First Cardiac Stem Cell Infusion Performed

Physicians at the University of Louisville in Kentucky have announced the successful completion of the world’s first cardiac stem cell infusion.

The patient, 66-year-old Michael Jones, had suffered the first of two heart attacks slightly over 4 years ago, and within 4 months of the second heart attack he was diagnosed with heart failure and permanent scarring of his heart as a result of multiple blocked arteries. Because he had not yet had bypass surgery, he was a good candidate for adult stem cell therapy. In March of this year he underwent bypass surgery for his blocked arteries, during which time Dr. Mark Slaughter, chief of cardiothoracic surgery at the University of Louisville and director of the Heart Transplant and Mechanical Assist Device Program at Jewish Hospital, removed a portion of tissue from the upper chamber of his heart. The tissue was then sent to Harvard University and Brigham and Women’s Hospital in Boston, where the endogenous cardiac stem cells were isolated, expanded and returned to Louisville where doctors injected the cells directly into the scar tissue of the heart via a minimally invasive catheterization procedure that was performed on July 17. Dr. Roberto Bolli, director of the Institute for Molecular Cardiology at the University of Louisville and distinguished chair in cardiology at the Jewish Hospital Heart and Lung Institute, led the study.

Before undergoing the autologous adult stem cell therapy, Mr. Jones had a left ventricular ejection fraction (LVEF) – a measure of the efficiency with which blood is pumped out of the heart’s left ventricle – that was lower than 25% but which is now around 30% and continues to increase. An LVEF of approximately 58% or higher is considered normal for healthy people.

Thus far, fourteen patients have been enrolled in the FDA-approved Phase I clinical trial which has a target enrollment of 20 patients. A second patient underwent the procedure on Friday, July 24.

According to James Ramsey, president of the University of Louisville, "It is an important, historic announcement. The number one killer is heart disease, and we in Kentucky have a higher incidence than the national average." Indeed, heart failure afflicts approximately 6 million Americans throughout the U.S. although the rate is unusually high in Kentucky, where as many as 14,000 deaths per year – in a state with a population of approximately 4 million people – are attributed to cardiovascular conditions, according to the American Heart Association.

As Michael Jones himself stated at a press conference today, "I am very, very grateful and honored to be chosen as the first recipient. This really seemed natural. It just made sense to use the body to regenerate itself." Looking physically well, strong, and fully recovered from the pioneering procedure that he underwent just a few days ago, he also added, "I hope to have as normal a life as anyone. I might even start jogging again."

Adult Stem Cells Act as Pacemaker

Scientists at the Chiba University Graduate School of Medicine in Japan have announced their discovery of a natural "biological pacemaker" in adult stem cells derived from adipose (fat) tissue. Specifically, the adult stem cells are mesenchymal stem cells (MSCs), and their naturally occurring "pacemaker" qualities may someday be useful in correcting electrical problems in the heart.

According to Dr. Toshinao Takahashi of the Chiba University, "Electronic pacemakers are often used as palliative therapy for people who have conduction problems with the electrical signals that govern the heart beat. However, that therapy has several shortcomings, including possible malfunction and the need for repeated replacement of the device’s power packs and electrodes. Cell therapy could overcome those problems and provide a possible cure for conductive disease. Our goal is to create a biological pacemaker."

The researchers harvested MSCs from the adipose tissue of mice which were then differentiated into beating cells which resembled heart cells in all features including cell surface proteins that serve as cardiac chemical markers. The new cells were then injected into mice who suffered from atrioventricular (AV) block, an electrical signaling problem of the heart which results in an abnormally reduced heart rate. Within a week after treatment with the new cells, the AV block was reversed to some extent, either completely or partially, in half of the mice who received the stem cell transplant.

Adipose tissue is known to be a rich source of MSCs which have been shown in numerous studies to differentiate into a wide variety of tissue types such as bone, muscle, liver, neuron and cardiac cells, among others. As the name implies, MSCs possess qualities of the "mesenchyme" – the unspecialized matrix cells that are found in the early embryo – which is in fact derived from all 3 germ layers, so one would therefore logically expect MSCs to be able to differentiate into most if not all cell and tissue types of the adult human body. Additionally, adipose tissue is known to exhibit a number of unique immunomodulatory properties which would also prove to be especially beneficial in the treatment of a variety of diseases and injuries (as recently reported by N.H. Riordan et al. in a publication in the April 24, 2009 issue of the Journal of Translational Medicine entitled, "Non-expanded adipose stromal vascular fraction cell therapy for multiple sclerosis").

In the particular treatment of disorders stemming from problems in cardiac electrical conduction and signaling, Dr. Takahashi has concluded that, "Our findings suggest that brown-fat-derived mesenchymal stem cells may become a useful cell source for antiarrhythmic therapy."

The results were presented at the American Heart Association’s Basic Cardiovascular Sciences Conference in Dallas.

NeoStem Featured on CBS

The first company to commercialize a method by which healthy adults may bank their own stem cells, NeoStem was the subject this past Sunday of the CBS television feature, "Eye on New York City".

NeoStem has pioneered a process by which endogenous adult stem cells that naturally reside in the bone marrow are "mobilized" to migrate into the peripheral blood, from which they are then collected through a process known as apheresis. Routinely used in other procedures such as the donation of blood platelets, apheresis allows stem cells to be easily separated from the other cells in the blood, so that the non-stem-cell cells may then be returned to the individual after the stem cells are removed. Apheresis is a minimally invasive, painless process that typically lasts approximately 3 to 4 hours, during which time the patient is awake and comfortable – all of which is highly preferable to bone marrow aspiration, the procedure for harvesting adult stem cells from bone marrow but which must be performed under general anesthesia due to the high level of pain that it causes. After the adult stem cells are collected via apheresis, the stem cells are then stored via a cryopreservation method and remain available to the individual indefinitely throughout the future for therapeutic use whenever needed.

According to Dr. Max Gomez, medical expert for CBS, autologous adult stem cells "have become the cutting edge way to treat osteoarthritis of the knee, hip, ankle and even back pain", among other ailments. Additionally, he adds, "The promise appears to be so great that more than 1,000 clinical trials are testing (autologous adult) stem cell therapies for various conditions and showing promising results for heart failure, diabetes, lupus and even macular degeneration", among other conditions.

According to Dr. Robin Smith, CEO of NeoStem, "NeoStem is very focused on autologous adult stem cell therapies being developed for multiple diseases." Among NeoStem’s recent acquisitions is an exclusive license for use of the technology which identifies and isolates VSELs (very small embryonic-like stem cells), which are not actually embryonic stem cells but nevertheless resemble embryonic stem cells in their pluripotency, and which are believed to have a number of potential clinical applications to the treatment of various diseases.

According to the company’s website, "NeoStem is the first company to provide adult stem cell collection and banking services to the general adult population. NeoStem’s medically proven process is a minimally invasive, painless and safe way to collect your adult stem cells. … There are tremendous clinical and economic advantages to autologous stem cell transplantation (receiving your own stem cells) as there are no issues with immune rejection. Engraftment with your own stem cells is faster, safer and much less costly than receiving someone else’s stem cells (allogeneic)." Additionally, as NeoStem points out on their website, "Currently, adult stem cell transplants have been successfully used as the standard of care in treating blood cancers such as leukemia, lymphomas and multiple myelomas. Today, over 2,000 clinical trials are being conducted in the United States looking at treatments for other diseases such as heart disease, diabetes, vascular disease, autoimmune disorders such as lupus, multiple sclerosis, Crohn’s disease, and many more. In addition, adult stem cells are now being used for certain cosmetic procedures and evaluated for further ones."

According to the actress Suzanne Somers, who has utilized NeoStem’s services for banking her own adult stem cells, "Stem cell therapy is the most exciting new breakthrough in medicine. It gives me great peace of mind to know that my own stem cells will be banked as bio-insurance for me. Now I am prepared for my future as the beneficiary of medical benefits while I am alive."

In June of this year, NeoStem signed an exclusive 10-year-long contract with the China-based company Enhance Biomedical Holdings for a collaboration in the development of a network of adult stem cell collection and treatment centers in Taiwan and throughout a number of provinces in China. (Please see the related news articles on this website, entitled "NeoStem Signs Adult Stem Cell Agreemenet in China", dated June 15, 2009, and "NeoStem CEO Invited to Address Medical Tourism at Conference", dated September 8, 2008).

Enrollment Begins in Adult Stem Cell Clinical Trial for Ischemic Stroke

The Canadian company Stem Cell Therapeutics (SCT) has received authorization from the Drug Controller General of India (DCGI) to begin enrollment in the Phase IIb clinical trial for the treatment of acute ischemic stroke with adult stem cells.

The double-blind, randomized, placebo-controlled clinical trial, which has a recruitment target of 128 to 130 patients, will utilize the modified REGENESIS proprietary protocol developed by SCT. Dr. Steven C. Cramer from UC-Irvine and Dr. Michael D. Hill of the University of Calgary are the two principle investigators of the study.

According to Dr. Alan Moore, president and CEO of SCT, "Approval from DCGI to initiate recruitment for the modified REGENESIS stroke trial in India is an exciting milestone for SCT. Jurisdictional approvals have now been granted in India, the U.S. and Canada, therefore we will begin recruiting patients as soon as possible."

In accordance with their regulations, the DCGI states that, "The DCGI approval process categorizes clinical trials into two types. If the study protocol has already been approved by a cognizant regulatory authority in one or more developed countries (such as the U.S., Canada, the U.K., Switzerland, Germany, Australia, Japan, and South Africa), the study is classified as a Type A trial and can be approved using a fast-track process within two to six weeks after the required documentation has been submitted. All other studies are classified as Type B. For these, the approval process is generally 8 to 12 weeks. The Institutional Review Board (IRB) approval process can be conducted in parallel with the DCGI review and, if import licenses are needed, the applications for these can also proceed in parallel. These provisions facilitate the process of getting study protocols in place and quickly initiating the trials." In other words, India is an excellent place in which to conduct clinical trials, since the approval process moves much more quickly than it does in many other countries. A number of businesses from the U.S., the U.K. and Europe are therefore turning to countries such as India for the testing and commercialization of their new medical products, whether related to stem cells or not.

In this particular case, the therapeutic product developed by SCT, known as REGENESIS, contains a proprietary combination of compounds which are designed to stimulate the body’s naturally occurring, endogenous adult stem cells for the healing and repair of damaged tissue. As described on the company’s website, "Stem Cell Therapeutics Corp. is a Canadian public biotechnology company focused on the development and commercialization of drug-based therapies to treat central nervous system diseases. SCT is a leader in the development of therapies that utilize drugs to stimulate a patient’s own resident stem cells. The Company’s programs aim to repair brain and nerve function lost due to disease or injury. The Company’s extensive patent portfolio of owned and licensed intellectual property supports the potential expansion into future clinical programs in numerous neurological diseases such as traumatic brain injury, multiple sclerosis, Huntington’s disease, Alzheimer’s disease, and ALS."

Heart Damage in Mice Repaired With iPS Cells

Researchers at the Mayo Clinic in Rochester, Minnesota, have used induced pluripotent stem (iPS) cells to treat damaged cardiac tissue in a mouse model of heart attack. The iPS cells were found to repair the heart tissue both structurally and functionally.

According to Timothy Nelson, M.D., Ph.D., one of the lead investigators of the research, "This study establishes the real potential for using iPS cells in cardiac treatment. Bioengineered fibroblasts acquired the capacity to repair and regenerate infarcted hearts."

Previously, iPS cells had been tested in animal models for three other diseases, namely, Parkinson’s disease, sickle cell anemia, and hemophilia A. This new study is the first of its kind in which iPS cells were tested specifically for their ability to regenerate cardiac tissue.

As Dr. Nelson further explains, "We’re taking advantage of a diseased tissue environment that is sending out a distress signal that is asking the tissue to repair itself. When we put these iPS cells in, they are able to respond. They were able to respond to this damaged environment and spontaneously give rise to the appropriate tissues and create new tissues within that diseased heart. That is a key ‘wow factor’ of this paper. It was obvious to the observer which animals had been treated and which ones hadn’t."

The scientists used fibroblasts which they genetically reprogrammed to dedifferentiate into iPS cells which were then redifferentiated into heart tissue. When transplanted directly into the damaged hearts of the mice, the new cells were found to have engrafted within two weeks of transplantation, and by 4 weeks the transplanted cells were found to have contributed to improved structure and function of the hearts. Not only did the iPS cells halt the progression of structural damage within the heart muscle itself, but the iPS cells were also found to regenerate new cardiac tissue which included not only heart muscle but also blood vessels. Ultrasound also revealed significant improvement in the ability of the hearts to pump blood.

According to Adre Terzic, M.D., Ph.D., Mayo Clinic physician and senior author of the study, "This iPS innovation lays the groundwork for translational applications. Through advances in nuclear programming, we should be able to reverse the fate of adult cells and customize ‘on demand’ cardiovascular regenerative medicine."

However, the researchers still used dangerous viral vectors for dedifferentiation of the fibroblasts into iPS cells, even though other scientists have replaced such methods with less dangerous reprogramming techniques.

Nevertheless, according to Dr. Nelson, he believes that iPS technology will be able to be used in clinical therapies to help people, eventually, even though it might take "several years". Until then, iPS cells are still ineligible for clinical therapeutic use since there are still a number of biological hurdles remaining that have yet to be overcome.

Meanwhile, autologous adult stem cells have already been used therapeutically in the clinical treatment of heart and other conditions, and are already available in clinics around the world – except, that is, in the U.S., where outdated FDA regulations have been unable to keep pace with scientific progress.

Cord Blood America Highlights 2009 Stem Cell Progress

Cord Blood America Inc. (CBAI), one of the largest providers in the world of umbilical cord blood stem cell preservation, reviews its accomplishments thus far in 2009. Even though the year is only half over, CBAI considers its achievements thus far in 2009 to be among the most significant in the company’s history. Some of its accomplishments in the first half of this year are described herein.

In January: The company launched its first social media campaign in the industry to start a public conversation about the potential usefulness of adult stem cells and the importance of storing umbilical cord blood. Additionally, the company established its "3 pillars of success" for 2009, which are, namely, organic growth, acquisitions, and debt reduction for an improvement in the company’s balance sheet.

In February: CBAI was listed on the ETF Innovators Stem Cell 40 company index. Additionally, CBAI announced $1 million in long-term debt reduction as part of its cash-flow restructuring.

In March: CBAI was noted as the top stock performer on ETF Innovators Stem Cell index, with a year-to-date stock price increase of 279% at that time.

In April: Congress introduced legislation to promote the "Family Banking of Umbilical Cord Blood" stem cells, which is a major boost to the entire cord blood banking industry. Additionally, CBAI received its first customer in Germany and announced a long-term debt reduction of over $2.5 million.

In May: CBAI announced that it had received $2.3 million for the purpose of building its own stem cell processing and storage laboratory, rather than continuing to outsource the services, which thereby resulted in a further debt reduction of $4.2 million.

In June: CBAI announced further expansion throughout Europe as well as independent contracting with affilates in the Caribbean and Central America.

In July: CBAI has further secured $7.5 in long-term equity financing for acquisition and growth opportunities, while also hiring a separate management team to direct its new stem cell laboratories in the U.S., which will be among the largest in the country, construction on which has already begun.

According to Matthew Schissler, chairman and CEO of CBAI, "On January 6, 2009, the closing CBAI stock price was $0.0017. On July 10, 2009, the closing stock price was $0.0033, a 94% increase in 6 months of trading. That’s not where we want to be, we are still very undervalued, and I understand that the day-to-day swings of our very liquid and volatile stock price cause some investor concern. I tell investors to take a snapshot of the last 6 months, not six hours. Micro cap stocks are perhaps not for the faint-of-heart. We believe we’re building a very valuable company and this snapshot of the past 6 months shows our progress."

Additionally, Mr. Schissler adds, "In January, CBAI stated its mission is to lay the foundation for a much stronger, healthier company by the end of 2009, which included organic growth, acquisition and debt reduction. As you can see by these highlights, we remain laser-focused on executing these strategies. Because of our focus, we are able to raise significant funding to build a lab with the future growth opportunities it affords us. We are also pleased by the current support of stem cell research in Washington, D.C. and Congressional and state legislative focus on family stem cell banking legislation."

CBAI is the parent company of Cord Partners, which was founded in 2002 and became operational on January 1, 2003. According to the company’s website, "Cord Partners, a Cord Blood America company, has established itself as a platinum standard national competitor in the umbilical cord blood storage industry… CBAI was founded on a simple principle: The families who seek stem cell preservation should never have to work to achieve this. By bundling such services as medical kit preparation, medical courier arrangement, 24/7 customer service, easy enrollment, and one price for all services, we feel an unparalleled commitment to our clinets, and have the foundation for providing the highest quality stem cell preservation available."

Umbilical cord blood is an extremely rich source of highly potent adult stem cells, such as mesenchymal stem cells and CD34+ cells, which have already been in use for decades in the clinical treatment of various diseases, safely and without side effects. Unlike embryonic stem cells, adult stem cells derived from umbilical cord blood are ethically noncontroversial, as umbilical cord blood is easily and harmlessly collectable.

Adult Stem Cells Treat Scleroderma

Mike George, a retired junior high school principal, had been suffering from an advanced case of systemic scleroderma. Translated literally as "hard skin", scleroderma is a chronic autoimmune disease characterized by fibrosis (tightening and hardening of tissue) and for which conventional medicine has no known cure. Of the two main versions of the disease, the systemic version (also known as diffuse cutaneous scleroderma) involves internal organs as well as the skin. In the version of the disease known as limited cutaneous scleroderma, symptoms are limited primarily to the skin, although secondary complications may manifest in the pulmonary system. Vascular complications are not uncommon in the systemic version, and when one or more internal organs are affected, the disease can be fatal.

Fourteen months ago, however, Mr. George underwent autologous adult stem cell therapy as part of a clinical trial at Northwestern Memorial Hospital in Chicago. Now, according to Mr. George, "I feel really good. I feel I was reborn. It’s great to be alive."

Prior to the therapy last year, Mr. George’s skin was stiff, his face was tight, he could only swallow with difficulty, any type of physical movement was an effort, and his doctors were concerned that the disease had begun spreading to his heart and lungs. Upon his return back home after the therapy, however, Mr. George was able to lift his luggage out of the trunk of his taxi – an accomplishment which had not been possible prior to the stem cell therapy. The next month, as Mr. George describes, his physician didn’t recognize him. "In April, the doctor said, are you sure I didn’t give you a lung transplant, instead of a stem cell transplant?" Although the stem cell therapy has not totally cured Mr. George, it has stopped the progression of the disease and to some extent reversed it, with noticeable improvement not only in his skin but also in his heart and lungs as well.

On May 17, 2005, it was announced that Northwestern Memorial Hospital and the Northwestern University Feinberg School of Medicine in Chicago together launched the Northwestern Scleroderma Program, which offers patients with scleroderma a unique program of comprehensive care. According to Dr. John Varga, a rheumatologist and director of the Northwestern Scleroderma Program, "Patients who are diagnosed with scleroderma are often told that there is little that can be done for them. At Northwestern, our integrated team of experts specializes in the treatment of scleroderma and all of its related conditions. We can offer patients treatment options they can’t find elsewhere, like bone marrow transplants, while also giving them access to other important disease management services such as physical and rehabilitative therapy and nutritional counseling and support." As described on their website, "The Northwestern Scleroderma Program offers the latest advances in diagnostics and treatment for scleroderma, including bronchoscopy and lavage, high-resolution CT scanning, right heart hemodynamics (blood circulation), advanced esophageal studies, innovative treatments for pulmonary hypertension and scleroderma lung disease, as well as autologous stem cell therapies."

In fact, on this website we have previously reported a number of times in the past on various clinical studies conducted at Northwestern Memorial Hospital in which patients have shown dramatic success after having received autologous adult stem cell therapy, usually for the treatment of other types of autoimmune diseases such as multiple sclerosis. In particular, Richard Burt, M.D., Chief of the Division of Immunotherapy for Autoimmune Diseases at Northwestern Memorial Hospital, is gaining increasing attention for his pioneering use of hematopoietic stem cells in the treatment of various autoimmune diseases which include not only multiple sclerosis but also rhematoid arthritis, lupus, and Chron’s disease, among others. In 2006 Dr. Burt was named within The Scientific American 50, which is the magazine’s annual list of outstanding leaders in science and technology. According to John Rennie, editor-in-chief of the magazine, "The Scientific American 50 pays tribute to individuals and organizations who, through their efforts in research, business and policy-making, are driving advances in science and technology that lay the groundwork for a better future. Not only does our list honor these prime movers, it shines a spotlight on the critical fields that are benefiting from their achievements." Continuing his distinguished and pioneering use of autologous adult stem cell therapy, Dr. Burt is currently involved in ongoing randomized clinical trials for a number of autoimmune diseases which include systemic scleroderma.

Usually, in clinical trials, patients are neither charged nor remunerated for their participation in the trial. However, even though the scleroderma clinical trials at Northwestern are FDA-approved and tightly controlled, nevertheless Mr. George had to pay for the medical services that he received as a participant in the study, which came to more than $200,000. Family members, friends, and the communities at his church and school district helped contribute to the cost of his medical expenses.

In the study, the autologous adult stem cells were harvested from Mr. George’s own bone marrow and then readministered to him therapeutically after having been isolated, purified and expanded in the laboratory. First, however, he also received a heavy dose of chemotherapy, the purpose of which was to "cleanse" his immune system before he received his own adult stem cells, which not only served as a therapy for his scleroderma but also "rescued" his immune system from deliberate destruction by the chemotherapy. The use of chemotherapy prior to autologous adult stem cell therapy is, unfortunately, not uncommon. Fortunately, however, the scientific logic of such a routine practice is becoming increasingly questioned.

In actuality, other doctors have already demonstrated success in treating various autoimmune diseases with adult stem cell therapy, but without the brutal and deliberate destruction of the immune system with chemotherapy. Known as immunological myeloablation, such a procedure had previously been considered a necessary part of any transplant therapy, even though it exposes the patient to potentially life-threatening risks. Today, however, an increasing number of doctors are questioning the logic and necessity of subjecting their patients to deliberate immune destruction, and with valid scientific reason. In a publication that appeared over two years ago, in the Journal of Translational Medicine in January of 2007, Dr. Neil H. Riordan et al. posed the following question: "…in patients who are not suffering from a disease that is associated with an aberrant bone marrow such as hematological malignancies or immunological dysfunctions, how is it justifiable to subject them to the high levels of morbidity and mortality associated with immune suppression?" Dr. Riordan and his team of scientists then examined compelling evidence which strongly indicates that pre-transplant immune suppression is unnecessary for autologous hematopoietic cell therapies and even for some types of allogeneic therapies, such as those that utilize "universal donor" cells such as mesenchymal stem cells and the CD34+ stem cells that are found in umbilical cord blood, and for which immune rejection is not even a concern. As Dr. Riordan and his colleagues wrote in their 2007 paper in a section that is subtitled, "Mesenchymal stem cells do not need myeloablation for efficacy": "Currently there are several ongoing clinical trials in Phase I-III using ‘universal donor’ mesenchymal stem cells in non-conditioned recipients of Crohn’s disease, GVHD (graft-versus-host disease) and myocardial infarction. Although these cells are bone marrow expanded mesenchymal cells, the superior proliferative potential of cord blood mesenchymal cells may allow them not only to escape immune destruction, but also to expand in vivo and mediate therapeutic effects superior to those derived from bone marrow. The fact that regulatory agencies have allowed advancement of ‘off-the-shelf’ universal donor mesenchymal stem cells supports the numerous reports of clinical efficacy in an allogeneic setting." Therefore, certainly with autologous (in which the donor and recipient are the same person) adult stem cell therapy, there is no risk of immune rejection so there is no need to destroy the immune system with chemotherapy; but even with many types of allogeneic (in which the donor and recipient are not the same person) adult stem cell therapy, such as with "immune privileged" "universal donor" stem cells, there is also no need to destroy the immune system with chemotherapy.

Nevertheless, for clinical trials such as those conducted at Northwestern University, the autologous adult stem cell therapies offer tangible improvement – at least for those patients who survive the life-threatening destruction of their immune systems from the chemotherapy. One can only conclude, therefore, as has already been demonstrated by other doctors at other clinics, that patients would exhibit even greater and faster improvement if they did not have to recover from the deliberate destruction of their immune systems prior to receiving the stem cell therapy. Additionally, other clinical evidence indicates that even greater patient improvement would be seen if the stem cell therapy would utilize the "superior proliferative potential" of the adult stem cells that are found in umbilical cord blood.

It has been estimated that between 150,000 and 300,000 people in the U.S. alone suffer from scleroderma. Having been one of the fortunate patients who was strong enough to survive the deliberate and unncessary destruction of his immune system prior to receiving his autologous adult stem cell therapy, Mr. George is now a devout believer in autologous adult stem cells. "I’m like an advocate," he says. "All my life, I wanted to help people. Helping kids was my forte. Now to help someone in need who doesn’t know what to expect, it raises it to a whole different level."

Clinical Results From Embryonic Stem Cells are “Decades Away”

In an article entitled "The Dirty Secret of Embryonic Stem Cell Research", the noted science journalist, author, attorney and director of the Independent Journalism Project, Michael Fumento, writes an eye-opening assessment of the stem cell field.

Michael Fumento begins his article in today’s issue of Forbes by citing the widespread, popular consensus among the general, nonscientific public that cures for all sorts of diseases are imminent, now that the infallible Obama administration has suddenly lifted all restrictions which the nefarious Bush administration imposed upon stem cell research. Such popular consensus, however, is grossly misguided and uninformed, as Mr. Fumento proceeds to demonstrate.

As Mr. Fumento points out, "Quadriplegics probably shouldn’t sign up for the New York City Marathon just yet. If these cures are just around the corner, this corner is far, far away. And that’s according to embryonic stem cell researchers and funding advocates themselves. The time frame for the first of those miracles seems routinely to be given as a ‘decade’, as in ‘a decade away’ or ‘a decade off.’ And it keeps shifting."

Fumento then reminds the reader that in 1998, when Dr. James Thomson isolated the first human embryonic stem cell in the laboratory, it was reported in an article at that time that Dr. Thomson and his colleagues themselves "warn that such clinical applications are perhaps as much as a decade away." That was in 1998, which by now was over a decade ago – and still, as of 2009, there have not yet been any clinical applications, not even one, that have resulted from human embryonic stem cell research. Continuing from the 1998 article, as Fumento then adds, "Check your calendar. Addressing a 2007 Wisconsin convention 9 years later, Thomson articulated that the time frame had shifted to ‘decades away’, plural."

As Fumento goes on to explain, "The scientists didn’t blame too little federal funding, as have others, according to the Associated Press. Rather, Thomson blamed simple biology. Among other problems, embryonic stem cells require permanent use of dangerous immunosuppressive drugs. They have a nasty tendency to form tumors both malignant and benign including teratomas – meaning ‘monster tumor’. Teratomas can grow larger than a football and can contain eyeball parts, hair and teeth." As Fumento further exclaims, "Yech!"

He goes on to ponder, "OK, so how many ‘decades’?" Among others, the answer is given by William Haseltine, former CEO of The Human Genome Project, who told the Agence France Presse in 2001 that, "The routine utilization of human embryonic stem cells for medicine is 20 to 30 years hence", to which Haseltine further added, "The timeline to commercialization is so long that I simply would not invest." There are other embryonic stem cell researchers, however, who believe that "3 to 5 decades" is more realistic, while the British fertility expert and Imperial College, London University professor Lord Robert Winston proclaimed in a 2005 lecture that, "I am not entirely convinced that embryonic stem cells will, in my lifetime and possibly anybody’s lifetime for that matter, be holding quite the promise that we desperately hope they will," further adding that "one of the problems is that in order to persuade the public that we must do this work, we often go rather too far in promising what we might achieve."

Fumento further points out that the 2007 AP article stated, "One day, some believe embryonic stem cells will become sources of brain tissue, muscle and bone marrow to replace diseased or injured body parts." In other words, maybe "one day" in the future, even though such goals have not yet been attained with human embryonic stem cells, not even as recently as 2007 nor even today in 2009. Meanwhile, however, various types of adult stem cells have already been differentiated into these and other types of tissue, decades ago. As Fumento explains, "Life-saving marrow regeneration with stem cells dates back to 1956."

Additionally, "Adult stem cells have now treated scores of illnesses including many cancers, autoimmune disease, cardiovascular disease, immunodeficiency disorders, neural degenerative diseases, anemias and other blood conditions," Fumento points out. "They’ve been used in over 2,000 human clinical trials. There has never been an embryonic stem cell clinical trial. Former National Institutes of Health director Dr. Bernardine Healy, once an embryonic stem cell research enthusiast, now calls them ‘obsolete’."

Indeed, as previously reported a number of times on this website, Dr. James Thomson himself – widely revered as "the father of embryonic stem cell science" – has often emphasized the importance of other types of cells, especially iPS (induced pluripotent stem) cells, over embryonic stem cells. In fact, the company which Dr. Thomson cofounded, Cellular Dynamics International, has as its primary focus today the commercialization of iPS cells, not embryonic stem cells – and not for the development of actual cell-based clinical therapies, but instead for the use of these iPS cells in drug screening and pharmaceutical development. (Please see a number of articles on this website related to Cellular Dynamics International, including but not limited to those entitled, "Leading Researcher Joins Cellular Dynamics", dated July 22, 2009; "Wisconsin Stem Cell Company Announces Licensing Agreement", dated July 15, 2009; "Cellular Dynamics Creates iPS Cells From Human Blood", dated July 8, 2009; and "Cellular Dynamics and Mount Sinai Sign Licensing Agreement", dated May 29, 2009).

As Fumento concludes, "In justifying his stem cell research executive order, President Barack Obama cited ‘a consensus of the majority of Americans.’ Actually, the polling responses vary tremendously depending on the questions asked. But no decision is better than the information upon which it’s based. What might Americans think if they knew the embryonic stem cell reseach ‘decades away’ secret?"

(Please see a number of articles on this website related to the embryonic stem cell versus adult stem cell controversy, including but not limited to that entitled, "Former Director of N.I.H. Explains Why Embryonic Stem Cells are Obsolete", dated March 4, 2009, as originally reported in U.S. News & World Report).

Adult Stem Cells Continue Going to the Dogs

Zack was suffering from a number of degenerative osteoarthritis conditions, despite the fact that he is only 14 years old. Of course, for a dog, 14 is not young. Fortunately for Zack, however, his owner decided to allow him to try stem cell therapy.

According to Deanna Winter, Zack’s owner who is also a doctor for people, "His main problem is arthritis. Trouble walking, trouble sitting and going upstairs." Furthermore, she adds, "His belly was almost touching the ground because he couldn’t hold his hips up. His quality of life was going down. He couldn’t make it around the block anymore."

Dr. Benjamin Ealing at Broad Ripple Animal Clinic in Indianapolis, not far from Zack’s home, has already used autologous adult stem cell treatment on 13 other dogs, successfully in each case. Dr. Ealing surgically removes abdominal fat from the dog, "which about fits in the palm of your hand and fills up two tubes", he describes. The adipose tissue is then shipped to the Vet-Stem laboratories in California where the stem cells are isolated, purified, expanded and returned to Dr. Ealing within 48 hours, already in syringes and ready to be injected into the site of the afflicted joints – which in Zack’s case were a hip and a shoulder. Although results are usually noticeable immediately, the greatest results take about 2 weeks to manifest. Now, two months later, Zack "can walk and he can sit and he can jump and he can go up stairs", as Deanna describes.

As Dr. Ealing adds, "The stem cells are the body’s own natural healing cells. Those cells then recruit the body’s own natural healing cells to come to that area, reduce inflammation, potentially to regenerate damaged tissue."

By now, Zack’s story is becoming an increasingly familiar one. As previously reported a number of times on this website, the company Vet-Stem continues to see consistently high success rates in both canine and equine clinical applications, with an 80% efficacy rate and a 100% safety rate in the animals that are treated with Vet-Stem’s autologous adult stem cell procedure. In other words, 80% of the animals treated are found to experience improvement in their condition with a reduction and often a full elimination of the need for medication, while adverse side effects have not been reported in any of the treated animals.

Since Vet-Stem first began marketing their services, they have now treated more than 2,000 dogs and more than 3,000 horses with autologous adult stem cells, extracted from each animal’s own fat. The procedure is quick, simple, minimally invasive, safe, highly effective, and while it is not cheap, it is less expensive than conventional surgical and pharmaceutical therapies which may not be effective at all. The first stem cell extraction and transplant for a dog typically run between $2,500 and $3,500, although the second transplant will often cost much less since extraction is only necessary once. The entire stem cell extraction procedure consists of the approximate equivalent of 2 to 3 tablespoons of the animal’s own adipose (fat) tissue which is surgically removed under anesthesia and shipped overnight to Vet-Stem’s laboratories in southern California where the stem cells are processed and returned two days later to the veterinarian who injects the stem cells back into the animal. Not only do the stem cells automatically target the injured tissue, but they also stimulate other endogenous stem cells which in turn are mobilized into action and participate in the healing and repair process. Although improvements are usually dramatic and immediate, even after the first injection, additional injections may be necessary, depending upon the age and condition of the animal. Very few animals ever need more than a total or 2 or 3 treatments, however, before they are fully restored to their natural, pain-free state of mobility – which contrasts sharply with conventional therapies such as most prescription medications which may need to be taken indefinitely, without ever producing any tangible signs of improvement and while even possibly causing further damage to the animal through dangerous side effects and other associated risks.

Vet-Stem uses exclusively adult stem cells, derived from each animal’s own tissue. Since the cells are autologous (in which the donor and recipient are the same animal), there is no risk of immune rejection. More specifically, the stem cells that are harvested in Vet-Stem’s procedure are mesenchymal stem cells, which are highly potent adult stem cells that are also found in bone marrow and umbilical cord blood. Numerous scientific and clinical studies have been published in the peer-reviewed medical literature detailing the regenerative properties of mesenchymal stem cells. No embryonic stem cells are ever used in Vet-Stem’s therapies, since embryonic stem cells are highly problematic in the laboratory, whether they are of human or non-human origin. Among other problems, the risk of teratoma (tumor) formation disqualifies embryonic stem cells for use as a clinical therapy, even in animals. Adult stem cells, however, do not pose such risks and are therefore rapidly accumulating a consistent history of successful clinical treatments in veterinary, as well as in human, medicine.

A number of companies throughout the world are replicating the procedure pioneered by Vet-Stem. It is fortunate – not only for Zack but also for his 2-legged friends who learn from his example – that such companies are able to conduct their business without the same burdensome federal legislation that continues to impede progress in human medical adult stem cell therapies in the United States.

(Please see a number of other related news article on this website, which include but are not limited to the most recent one entitled, "Veterinary Stem Cell Therapies Translate into Human Therapies", dated July 14, 2009).

Veterinary Stem Cell Therapies Translate into Human Therapies

As previously reported on this website a number of times, rapid progress has been made over the past few years in veterinary medicine using autologous adult stem cells. Now, the consistent success of such therapy is finally getting the attention of the human medical community, which is beginning to replicate the veterinary procedures in human clinical trials.

Autologous (in which the donor and recipient are the same individual, whether a person or a dog or a horse) adult stem cell therapy has been routinely used in recent years for the treatment of a variety of conditions in large domesticated animals. Such conditions most commonly include orthopedic injuries in competitive horses, while in dogs the most commonly treated condition is age-related degenerative osteoarthritis. Although such stem cell therapies could also be of benefit to smaller animals such as cats, orthopedic injuries are not usually life-threatening to these smaller animals whereas such an injury could be fatal for a thoroughbred race horse. Consequently, veterinary stem cell therapy has been applied very aggressively to these valuable, expensive, large animals whose lives and competitive careers have literally been saved by such therapies. Even for dogs who do not earn large salaries in high-profile competitions but who are merely beloved pets, autologous adult stem cell therapy has also proven to be life-saving. Meanwhile, in human medicine, however, nothing whatsoever has been allowed to happen in U.S. clinics outside of a small number of government-approved clinical trials, thanks to an outdated, lengthy, lethargic and prohibitively expensive FDA approval process. It is hardly surprising, therefore, that veterinary stem cell medicine has quickly outpaced human stem cell medicine – but now, at last, humans are beginning to learn something from their canine and equine friends.

Companies such as Vet-Stem in the U.S. and VetCell in the U.K. have accumulated numerous documented cases of the benefits of autologous adult stem cell therapy in animals. To name just a few of the advantages, adult stem cell therapy yields faster healing and shorter recovery times than surgical treatments do, and adult stem cell therapy does not pose a risk of any side effects like medications do. Additionally, since the adult stem cells are autologous, there is no risk of immune injection. The U.K. company VetCell derives the autologous adult stem cells from the animal’s bone marrow, and to date has treated approximately 1,700 horses with an 80% success rate. By comparison, the U.S. company Vet-Stem derives the autologous adult stem cells from the animal’s adipose (fat) tissue, and to date has treated over 2,000 dogs and over 3,000 horses, also with an 80% success rate. With both companies, the procedure is quick, simple, and minimally invasive. Although the treatment is more expensive than conventional veterinary procedures, the adult stem cell treatment actually works, and noticeable improvement is seen almost immediately in all cases, not just in the 80% of cases that exhibit a complete recovery. By sharp contrast, however, conventional surgical and pharmacological therapies, which might initially be less expensive than stem cell therapy, only have a 30% success rate and therefore in the long-term are actually more expensive when repeated treatment is needed, or when improvements are not seen at all. Additionally, reinjury is significantly lower in animals who receive autologous adult stem cell therapy, due to the mechanism of action by which these stem cells activate the healing process. As Dr. David Mountford, a veterinary surgeon and chief operating officer at VetCell, explains, "After 3 years, the reinjury rate was much lower in stem-cell-treated animals: about 23% compared with the published average of 56%" for animals treated with conventional therapies.

According to Dr. Sean Owens, veterinarian and founding director of the Regenerative Medicine Laboratory at UC-Davis, "Soft-tissue injury is the number-one injury competitive horses will suffer, and it can end a thoroughbred horse’s career." Additionally, Dr. Owens adds, "Regulatory oversight of veterinary medicine is minimal. For the most part, the USDA (U.S. Department of Agriculture) and the FDA (Food and Drug Administration) have not waded into the regulatory arena for us." Precisely because of such a lack of federal government regulation in the veterinary industry, this newly created research center which Dr. Owens has established is able to dedicate itself to the advancement of animal stem cell medicine, which in turn should translate into the advancement of human stem cell medicine through parallel clinical trials. A number of ongoing clinical trials in horses are conducted at the Laboratory, which include those for tendon tears and those for fractured bone chips in the knee – and now a similar type of autologous adult stem cell therapy for these same conditions will be developed for human clinical trials. Ultimately, such a program will result not only in the development of better treatments for horses, but also in the development of better treatments for humans. Currently Dr. Owens is collaborating with Dr. Jan Nolta, director of the Stem Cell Program at UC-Davis, who has been appointed to oversee the human trials. As Dr. Owens explains, "Part of our mission is to do basic science and clinical trials and also improve ways of processing cells."

Similarly, VetCell of the U.K. initially chose to focus specifically on tendon injuries in horses precisely because these injuries bear such a close resemblance to the same injuries in humans, and therefore the medical procedures should be easily translatable from veterinary to human medicine. In fact, while damage to a rotator cuff or an Achilles tendon would certainly be extremely painful in a human, it probably would not be fatal, whereas such injuries in a horse could prove fatal. The veterinary procedures have therefore had to advance very carefully and meticulously – despite the absence of a controlling government regulatory system – merely because of the severe and extreme nature of such animal injuries. Next year, VetCell plans to begin autologous adult stem cell therapy for human patients with Achilles tendon damage, which will mark VetCell’s first human clinical trials in which an equine procedure will be translated to a human procedure. As with the horses, the human autologous adult stem cells will be derived from each human patient’s own bone marrow, from which the stem cells will then be isolated, purified, expanded and readministered to the patient therapeutically, usually by injection directly into the area of tissue damage. According to Dr. Mountford, "Our long-term goal is to use it to treat a number of tendon injuries."

Likewise, Vet-Stem of California has already demonstrated success in a double-blind, placebo-controlled clinical trial with autologous adult stem cells in the treatment of arthritic dogs. As Dr. Robert Harman, veterinarian and founding CEO of the company, points out, "About 200,000 hip replacements are done every year in humans. That’s a very good target for someone to look at cell therapy." Adipose-derived stem cells have been shown in a number of studies to exhibit highly beneficial immunomodulatory properties – which reduce inflammation, among other benefits – in addition to stimulating the regeneration of cartilage and other tissue. (E.g., "Non-expanded adipose stromal vascular fraction cell therapy for multiple sclerosis", by N.H. Riordan et al., published in the Journal of Translational Medicine in April of 2009, of which Dr. Harman is a coauthor). As Dr. Harman further explains, "In the last couple of years, evidence has come out that the cells we use reduce inflammation and pain, and help lubricate the joint."

Ordinarily, injuries of the bones, joints, tendons and ligaments result in scarring of the tissue, which not only prevents full healing but also often leads to further injuries at a later time. Conventional medical therapies do nothing to address the problem of scar tissue directly, and surgical procedures actually make the problem worse by increasing the severity of tissue scarring which in turn merely exacerbates later complications that will inevitably result from the scar tissue, since such tissue can never be fully rehabilitated. Stem cell therapy, however, allows for the full and complete healing of tissue without scarring, which not only reduces the risk of re-injury of the same tissue at a later date but also restores full physical performance and function, usually very quickly and dramatically. Such is the case in humans as well as in animals. As Dr. Harman succinctly states, "Our success in animals is directly translatable to humans, and we wish to share our evidence that stem cells are safe and effective."

Although Vet-Stem was the first company to commercialize the process in the U.S., and VetCell was the first to do so in the U.K., a number of other companies throughout the world are now also utilizing similar types of technology in which adult stem cells are derived from each animal’s own tissue and readministered to the animal as a clinical therapy for the particular medical condition from which the animal suffers. Autologous adult stem cell therapy has proven to be a highly preferable alternative treatment for many animals, especially those whose conditions require surgery or anti-inflammatory drugs, both of which can often be avoided with the stem cell therapy.

Vet-Stem was founded in 2002 as the result of stem cell research conducted at the University of Pittsburgh and UCLA in the late 1990s, when Dr. Bob Harman saw the commercial potential for veterinary applications of such stem cell technology. A veterinarian himself, as well as a statistician and former biotech entrepreneur who had already held the top executive title at 3 biotechnology companies prior to Vet-Stem, Dr. Harman is now the CEO of Vet-Stem as well as one of its founders. Based in San Diego, Vet-Stem patterned its initial clinical model upon the example of other companies that were already involved in human adult stem cell therapies, such as Cytori Therapeutics which had developed a proprietary separation apparatus that harvests human adult stem cells from adipose tissue at the patient’s bedside during reconstructive or cosmetic surgery. In a similar procedure, veterinarians extract approximately 2 to 3 tablespoons of adipose tissue from each animal, which are then sent to Vet-Stem’s laboratories where the adult stem cells are isolated, purified, expanded and returned within 48 hours to the veterinarian who then administers the stem cells to the animal. The procedure has demonstrated a consistently high success rate and its use is becoming increasingly widespread not only for horses but also for dogs. Among other partnerships, in September of 2007 Vet-Stem licensed their proprietary adult stem cell technology to the Central Veterinary Research Laboratory (CVRL) of Dubai in the United Arab Emirates, thereby allowing the CVRL to offer the same adipose-derived adult stem cell animal therapies throughout the Middle East. Sheik Mohammed bin Rashid al-Maktoum, the ruler of Dubai and the Prime Minister of the UAE, is an avid thoroughbred owner and a sponsor of the Dubai World Cup, the world’s most highly-prized horse race. As Dr. Harman described in 2007, "The Central Veterinary Research Laboratory will be an excellent partner in bringing this technology from the U.S. to the Middle East as they are already the most respected reference lab in the region." CVRL now provides stem cell services for the treatment of injuries not only in thoroughbred race horses and Arabian endurance horses, but also in racing camels, among other species, throughout the Middle East. As already mentioned, to date Vet-Stem has treated over 3,000 horses and over 2,000 dogs with joint injuries and degenerative conditions that include tendon and ligament injuries as well as age-related osteoarthritis. Vet-Stem’s overall success rate is around 80% in the number of animals who are able to return to normal performance, a rate that is significantly above that of conventional surgical and pharmaceutical therapies.

VetCell Bioscience developed the equine autologous adult stem cell procedure in the U.K., where such therapy is now routine practice at most equine veterinary locations and is even covered by most equine insurance policies. VetCell uses mesenchymal stem cells (MSCs) that are derived from the animal’s own bone marrow which is extracted from the horse’s sternum, from which the MSCs are then isolated, expanded to more than 10 million cells, re-suspended in bone marrow supernatant which is rich in growth factors and other chemical nutrients, and then the cells are injected directly into the site of the injury where the cells regenerate the tendon tissue and also prevent the formation of scar tissue, which is often a main hindrance to healing and the cause of future reinjury. Physical rehabilitation and a controlled exercise program are also important to the recovery of the horse, and periodic MRI (magnetic resonance imaging) scans are taken to monitor the healing. VetCell Bioscience specializes in the development and commercialization of new biotechnologies for veterinarian musculoskeletal regeneration. VetCell was formed in partnership with the Royal Veterinary College and the Institute for Orthopaedic and Musculoskeletal Science, and is a trading company within MedCell Bioscience, its parent company, which develops musculoskeletal regenerative therapeutics for human clinical treatment. As stated on their website, "VetCell has rapidly commercialised a technique for the multiplication of equine stem cells which can be used in the treatment of tendon and ligament injury. This service is now available to veterinary surgeons in the U.K. and internationally. VetCell has also developed a simple method for separating and storing stem cells from the umbilical cords of foals." Although VetCell specializes in the treatment of horse injuries, they are also expanding their services and products to therapeutic applications for dogs, cats and other domestic species, in addition to their human clinical trials which will commence next year. Headquartered in Cambridge, England with laboratories in Edinburgh, Scotland, MedCell and VetCell also have offices in Germany, Spain, China, Australia, South America, Canada and the United States.

Both Vet-Stem and VetCell use exclusively adult stem cells, derived from each animal’s own tissue. Since the cells are autologous (in which the donor and recipient are the same animal), there is no risk of immune rejection. More specifically, the stem cells that are harvested in both procedures are mesenchymal stem cells (MSCs), which are highly potent adult stem cells that are found not only in bone marrow and adipose tissue but also umbilical cord blood. Numerous scientific and clinical studies have been published in the peer-reviewed medical literature detailing the regenerative properties of MSCs.

No embryonic stem cells are ever used in either Vet-Stem’s or VetCell’s therapies, since embryonic stem cells are highly problematic in the laboratory, whether they are of human or non-human origin. Among other problems, the risk of teratoma (tumor) formation disqualifies embryonic stem cells for use as a clinical therapy, even in animals. Adult stem cells, however, do not pose such risks and are therefore rapidly accumulating a consistent history of successful clinical treatments in veterinary, as well as in human, medicine.