Bioheart Approved for Clinical Trial

Bioheart announced today that it has received U.S. FDA approval to begin testing it proprietary adult stem cell product, MyoCell SDF-1, for use in the treatment of heart failure. The Phase I clinical trial has a target enrollment of 15 patients and is scheduled to commence later this year.

MyoCell SDF-1 contains autologous (in which the donor and recipient are the same person) adult myogenic stem cells that are derived from each patient’s own thigh muscle and which are then genetically modified to produce specific growth factors (such as the cytokine known as stromal cell-derived factor-1) which are involved in the regeneration of muscle tissue. According to Howard Leonhardt, chairman and CEO of Bioheart, "To our knowledge, this will be the first clinical trial ever to test a combination gene and stem cell therapy for cardiovascular disease."

Headquartered in Florida and founded in 1999, Bioheart is focused on the development and commercialization of autologous adult stem cell therapies for the treatment of chronic and acute heart damage. As described on their website, "Our lead product candidate is MyoCell, an innovative clinical therapy designed to populate regions of scar tissue within a patient’s heart with autologous muscle cells, or cells from the patient’s body, for the purpose of improving cardiac function in chronic heart failure patients. The core technology used in MyoCell has been the subject of human clinical trials conducted over the last six years involving 95 enrollees and 76 treated patients. Our most recent clinical trials of MyoCell include the SEISMIC Trial, a completed 40-patient, randomized, multicenter, controlled, Phase II-a study conducted in Europe and the MYOHEART Trial, a completed 20-patient, multicenter, Phase I dose-escalation trial conducted in the United States."

Additionally, Bioheart has also been cleared by the U.S. FDA to proceed with its "MARVEL Trial" – a 330-patient, multicenter Phase II/III trial of MyoCell to be conducted in North America and Europe. Additional products in Bioheart’s pipeline include multiple candidates for the treatment of heart damage such as the Bioheart Acute Cell Therapy, a proprietary formulation of autologous adult stem cells derived from adipose tissue.

Three Nebraska Universities Receive Grants for Adult Stem Cell Research

Today three universities in Nebraska have announced that they are to receive state grants in order to conduct stem cell research that strictly and exclusively involves adult stem cells, not embryonic stem cells. The recipients include Creighton University School of Medicine, the University of Nebraska Medical Center (UNMC), and the University of Nebraska at Lincoln, each of whom have been awarded a $150,000 research grant.

The three grants have been awarded in accordance with the Nebraska Stem Cell Research Act of 2008, which stipulates that neither state money nor state facilities may be used for research purposes in which the destruction of a human embryo is involved. Nonembryonic, adult stem cell research is strongly encouraged under the Act, and funding for the grants comes from the state’s tobacco lawsuit settlement funds.

The grants were recommended by Nebraska’s Stem Cell Advisory Committee, which consists of deans of the medical schools at Creighton and UNMC as well as four scientists from outside of Nebraska.

According to Tom Murray, dean of research at Creighton University School of Medicine, the grant is also in accordance with Creighton’s policy against the destruction of human embryos. Researchers at Creighton plan to use the grant money to conduct research on stem cells in mice for the development of therapeutic strategies in the treatment of hearing loss. Researchers at UNMC intend to use the grant money to study human adult stem cells in the treatment of vision loss.

Adult Stem Cells Treat Cancer

A patient with multiple myeloma has been treated with his own autologous adult stem cells, and is now cancer-free.

Since receiving a kidney transplant 15 years ago, the patient – who has chosen to remain anonymous – has had to take immuno-suppressant drugs. Upon being diagnosed with multiple myeloma a year and a half ago, the patient suddenly faced a dilemma: reduction of the immunosuppressing drugs might have allowed his body to fight the cancer, but also could have resulted in rejection of the transplanted kidney. His doctors therefore recommended that he undergo treatment with his own bone-marrow-derived autologous adult stem cells.

The procedure was performed a month ago on the 49-year-old patient. Now, a PET (positron emission tomography) scan revealed that he is free of cancer.

According to nephrologist Dr. Madan Bahadur, this patient "is the first kidney transplant patient in the world to undergo a stem cell transplant to beat multiple myeloma after ablative chemotherapy." In addition to Dr. Bahadur, the patient was also treated by hematologist Dr. Sameer Shah and oncologist Dr. Ganpati Bhat at Mumbai’s Jaslok Hospital.

According to Dr. V. Hase, chief of nephrology at Mumbai’s King Edward Memorial Hospital, "The Jaslok patient’s case is of great academic interest. Firstly, it is rare for a kidney transplant patient to develop multiple myeloma. Secondly, no transplant patient in India has undergone a stem cell transplant as a rescue mission against cancer."

As Dr. Hase further adds, in light of the fact that renal failure is a known complication of multiple myeloma, "In the Western world, multiple myeloma patients would undergo the stem cell transplant first and a renal transplant later. But in the Mumbai case, the opposite has happened."

The results of the transplant are scheduled to appear in the European journal, Nephrology Dialysis Transplant.

Federal Court Ruling Issued on Stem Cell Patent Dispute

Two researchers at the University of Piitsburgh have won a patent dispute in the Federal Circuit over a laboratory procedure by which adult stem cells derived from human adipose (fat) tissue may be differentiated into cartilage, muscle and bone cells. The Court rejected a bid by researchers at UCLA who had claimed credit as co-inventors of the process.

University of Pittsburgh researchers Drs. Adam Katz and Ramon Llull first began researching adipose-derived adult stem cells in the 1990s. Along with Dr. Marc Hedrick, who temporarily joined their laboratory at a later date, the researchers formally announced in April of 1998 that the adipose-derived stem cells could be differentiated into cartilage, muscle and bone tissue. The actual date of the discovery, however, was listed as October of 1996.

At the crux of the dispute is the fact that Dr. Hedrick temporarily joined the University of Pittsburgh laboratory under a year-long fellowship, at the completion of which he returned to UCLA where he continued to study adult stem cells of adipose origin along with his UCLA colleagues Drs. Hermann Peter Lorenz, Min Zhu, and Propser Benhaim.

Both teams of researchers at both universities then filed separate patent applications for the same laboratory methods and materials by which the stem cells are differentiated into other tissue types. Although the University of Pittsburgh had originally filed an international patent application in 2000 on which Katz, Llull, Hedrick, Lorenz, Zhu and Benhaim were all listed as co-inventors, Katz and Llull later sought to remove the names of Hedrick and the other UCLA researchers from the application.

When the UCLA researchers challenged the claim by Katz and Llull as sole inventors of the process, the district court of Pittsburgh ruled in favor of Katz and Llull, decreeing that these two researchers had invented the procedure prior to Hedrick’s fellowship. The UCLA team of researchers then appealed the decision, claiming that the research was "inconclusive" until Hedrick had been added to the team – a claim which was overruled in Washington, D.C. by the U.S. Federal Court of Appeals.

According to the presiding judge, the Honorable H. Robert Mayer, who has served as Chief Circuit Judge of the United States Court of Appeals for the Federal Circuit since his appointment as such in 2004, "Proof that the invention works to a scientific certainty is reduction to practice. Therefore, because the district court found evidence that Katz and Llull formed a definite and permanent idea of the cells’ inventive qualities, and had in fact observed them, it is immaterial that their knowledge was not scientifically certain and that the [defendant] researchers helped them gain such scientific certainty."

Law suits are not uncommon in the biotech industry, and challenges to patent and copyright law are occurring with increasing frequency every day, especially in the stem cell field. No doubt this recent ruling – in favor of the initiating scientists who had "formed a definite and permanent idea" of the outcome despite the fact that such impressions were "not scientifically certain" – will now be cited as a precedent in future legal disputes of a similar nature.

Progress Made Toward an Implantable Bone

Researchers at the Imperial College in London have made some important discoveries in the process by which different types of stem cells differentiate into bone. The findings have direct applications to the development of stem cell therapies for the treatment of various bone injuries.

Specifically, the scientists found significant differences in "bone-like" material that was grown from 3 different types of cells taken from mice. Two of those cell types – namely, osteoblasts that were derived from the skulls of the mice, and mesenchymal stem cells that were derived from the bone marrow of the mice – were found to be capable of differentiating into a tissue that resembles "native" bone in all of its features, including matrix complexity and mechanical stiffness. The third type, however, was less promising. When the scientists tried to differentiate mouse embryonic stem cells into bone, the result was a tissue that was much less stiff and not as complex as real bone in its mineral composition. Upon further analysis with high resolution electron microscopy, a nano-indenter, and laser-based Raman spectroscopy, the scientists found that only the bone tissue that was differentiated from the two types of adult stem cells actually possessed both the microscopic and the macroscopic properties of real bone.

According to Dr. Molly Stevens of the Department of Materials and the Institute of Biomedical Engineering at the Imperial College of London, "Many patients who have had bone removed because of tumors or accidents live in real pain. By repairing bone defect sites in the body with bone-like material that best mimics the properties of their real bone, we could improve their lives immeasurably. Our study provides an important insight into how different cell sources can really influence the quality of bone that we can produce. It brings us one step closer to developing materials that will have the highest chance of success when implanted into patients."

A number of researchers around the world are currently working on the task of growing small "nodules" of new bone from stem cells in the laboratory, and a number of clinical trials are already underway. Now, the results of this new study allow scientists to pinpoint more precisely which type of stem cell is the best type to be the originating source of the bone.

Adult Stem Cells Treat Gum Disease

Researchers at the University of Adelaide have been using adult stem cells to treat gum disease in preclinical animal trials, with significant success. Now, the scientists have been awarded $200,000 in funding from the Australian Stem Cell Centre to expand their research to humans.

According to Dr. Mark Bartold of the University of Adelaide, "We’ve got the proof, in principle, and can regrow a lot of bone around the teeth and restore some of the damage that has been done. As with any new technology, we’ve still got a little way to go. There’s a lot of unanswered questions and more will pop up along the way."

In the past, Dr. Bartold and his colleagues have taken adult stem cells from the jawbones of sheep and pigs, which were then cultured and re-implanted into other animals in whom gum disease had caused bone loss around their teeth. Specifically, the adult stem cells were derived from the ligament that secures the teeth into the jawbones of the animals. Now, the method will be applied to people.

According to Dr. Bartold, it has been estimated that approximately 60% of all Australians suffer from some form of gum disease, in whom it is not uncommon to see advanced stages of periodontitis. In theory, therefore, a cell-based therapy for gum diseases would have a large market in Australia.

Heart Stem Cells Activated for Healing

Scientists have discovered a new method for stimulating endogenous heart stem cells to heal damaged heart tissue. Although the study was conducted in an animal model, the results of the study have direct applications to the treatment of various heart conditions in humans.

Led by Dr. Bernhard Kuhn of Harvard Medical School, researchers at Children’s Hospital in Boston have found that the protein neuregulin1 (NRG1) can be used to stimulate endogenous heart stem cells to re-enter the cell cycle, thereby allowing the stem cells to regenerate new heart tissue.

As Dr. Kuhn explains, "To my knowledge, this is the first regenerative therapy that may be applicable in a systemic way. In principle, there is nothing to preclude this going into the clinic. Based on all the information we have, this is a promising candidate."

For example, Dr. Kuhn and his colleagues surmise that someday it might be a routine protocol for patients to receive daily infusions of NRG1 over a period of weeks. As Dr. Kuhn adds, "Contemporary heart failure treatment is directed at making the remaining cardiomyocytes function better, and improvements in outcomes are harder and harder to achieve because these therapies have become so good. But despite this, heart failure is still a fatal disease. Therapies that replace lost heart muscle cells have the potential to advance the field."

Adult stem cells are already known to reside in a number of various tissue types throughout the human body, and they are suspected of residing in all tissue types. Although an endogenous heart stem cell has been identified and is known to exist, it does not exist in large numbers throughout the heart and is therefore not usually sufficient, in and of itself, to repair damaged heart tissue following an acute event such as a heart attack. A number of studies have examined various ways of stimulating other types of stem cells that are not found in the heart to differentiate into new heart cells, but Dr. Kuhn’s study is unique in that it has demonstrated a novel approach to stimulating the endogenous heart stem cells that are already in the heart to regenerate the heart’s own tissue.

In the study, the scientists treated mice with daily injections of NRG1, beginning at one week following the laboratory-induced injury. Within 12 weeks, the mice not only exhibited improved heart function, but they were also found to have an increased number of resident heart muscle cells as well as a reduction in heart muscle scar tissue. As Dr. Kuhn explains, "Most of the related cell death had already occurred. When we began the injections, we saw replacement of a significant number of cardiomyocytes resulting in significant structural and functional improvements in the heart muscle."

In 2007 the the same team of scientists reported that the protein periostin – which is found in developing fetal heart and injured skeletal muscles – also induces cardiomyocyte production and improved heart function in rats. Instead of being injected, however, the periostin was administered via patches that were placed directly on the heart tissue. In light of this current, new study, further trials are now proposed in which periostin and NRG1 could be used together as a combined therapy. According to Dr. Kuhn, "During initial treatment, patients might receive neuregulin injections, and once they are stable and out of the ICU they might be taken to the cath lab for a periostin patch."

According to Duke University cardiologist Dr. Richard C. Becker, who is also a spokesman for the American Heart Association, "This is something that I suspect people in the field of cardiology will be very excited about, and I suspect this interest will stimulate additional research."

Veterinary Adult Stem Cell Therapies Rapidly Progressing

Cris, a 5-year-old police dog in the San Francisco Bay Area, was suddenly faced with an early retirement following a muscle injury. Similarly, the 12-year-old mare and winner of the 2006 championship in Scotland, Marsh Mayfly, was incapacitated after incurring a torn tendon during a competition. But now, both animals have returned to their productive careers after having been treated with their own adult stem cells. In fact, in Cris’s case, a sonogram revealed that the dog’s previously injured hamstring muscle had been completely restored to its normal condition a mere 8 weeks after the adult stem cell therapy was administered.

Collectively, the U.S. company Vet-Stem and the U.K. company MedCell Biosciences have treated over 5,500 horses and 1,700 dogs with their respective autologous adult stem cell therapies, for which veterinarians usually charge around $3,000 per procedure. According to Dr. Hubert Kim, orthopedic surgeon and director of the Cartilage Repair and Regeneration Center at UC-San Francisco, "The results in animals provide an exciting look forward into what human therapies might look like. It gives you a snapshot of what may be possible."

As Dr. Gregory Ferraro, director of the Center for Equine Health at UC-Davis, explains, "Stem cell therapeutics is the most exciting development that has occurred in the 38 years I’ve been a veterinarian. By treating animal disease with stem cells, we can learn to treat animals better and find new ways to help humans."

The University of California at Davis boasts an impressive veterinary adult stem cell program which was funded in part by a $2.5 million donation from Dick Randall, a former real estate executive who now owns and breeds competition horses. When Hustlers Starlight, one of Randall’s horses, suffered a ligament injury, the veterinarian recommended Vet-Stem’s services. Within 2 months after treatment, the horse was exercising with a rider once again. Since then, Randall has had 8 other horses treated with Vet-Stem’s procedure. Similarly, Tim McQuay, who operates the 200-horse facility at McQuay Stables in Tioga, Texas, has had 50 horses treated by Vet-Stem, 90% of whom have shown dramatic improvement. Not only do the autologous adult stem cells regenerate damaged tissue, but they also exhibit important immunomodulatory properties that reduce inflammation. A number of clinical trials in horses and dogs have been published in the veterinary literature and are believed to be directly translatable to human therapies. As Sean Owens, assistant director of the Regenerative Medicine Laboratory at UC-Davis, points out, "Sometimes things get driven along because the public wants it. We want to show if this is as effective as the public thinks."

According to Linda Powers of Toucan Capital in Bethesda, Maryland, which provided $2.4 million in start-up funding for Vet-Stem in 2002, "The market is gigantic. We Americans are crazy for our pets." This year Vet-Stem expects to report around $4.5 million in revenue.

Indeed, the U.S. veterinary market is one of the largest in the world, which is precisely why MedCell of the U.K. entered the U.S. market last year by opening a branch in Florida, from which its VetCell unit has treated around 2,500 horses thus far. Additionally, the company also treats between 80 and 100 dogs per month.

While Vet-Stem’s procedure takes less than 48 hours to produce a ready-to-deliver therapy from adipose-derived stem cells, MedCell’s procedure takes 3 to 4 weeks to produce a stem cell therapy from bone-marrow-derived stem cells. In either case, the results are directly translatable to humans, and MedCell has received authorization from British regulators to begin human clinical trials during the first quarter of 2010 for the use of bone-marrow-derived autologous adult stem cells in the treatment of torn Achilles tendons and rotator cuffs. Results of the clinical trial are expected to be available in time for promotion of the treatment during the 2012 Olympic Games in London.

Jan Nolta, director of the human stem cell program at the UC-Davis medical school, estimates that at least 1,000 people have participated in U.S. FDA-approved clinical trials in which adult stem cells were used as therapies for a wide variety of medical conditions which include not only orthopedic problems but also heart disease and autoimmune disorders, among others. By sharp contrast, not one person has yet received human embryonic stem cells in any clinical trials. As Robin Young, an investment analyst who follows stem cell companies, points out, "Orthopedics will be the sector of medicine where new technologies like stem cells will find their first utilization."

According to Dr. Gary Brown, the veterinarian who treated Cris the police dog as well as two other dogs, all 3 dogs "have done fantastic. We’ve got reason for hope here. We can take dogs that would go into early retirement and keep them fighting bad guys for many years."

Stem Cell Therapies Are Not Just for the Dogs

Prior to being diagnosed with severe arthritis last year, Ezri used to compete in agility contests. But then the ten-year-old Border Collie began slowing down and showing signs of pain in her front paws. According to Ezri’s owner, Kim Galusha, "She was limping and we tried all kinds of different pain medications and arthritis treatments but nothing helped. She got to the point where all she wanted to do was sleep on the couch."

Thanks to veterinary surgeon Dr. Stephen Kerpsack, however, the dog underwent a successful autologous adult stem cell transplant. Dr. Kerpsack derived approximately 2 tablespoons of fat from Ezri’s abdominal adipose (fat) tissue, which was then mailed the the Vet-Stem laboratory in San Diego where the adult stem cells were isolated, expanded and returned within 48 hours to Dr. Kerpsack who injected the adult stem cells directly into the arthritic joints of Ezri’s front legs. Within 4 to 6 weeks, Ezri was back to her usual self. According to Kim, "You could just tell she had a real big attitude change. She wanted to play."

As Dr. Stephen Kerpsack explains, "In that fat are what are called stem cells. The stem cells have the ability to become other types of cells, which can repair tissue in the body."

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.

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.

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.

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. Adult 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. According to Dr. Robert Harman, veterinarian and founding CEO of Vet-Stem, "Our success in animals is directly translatable to humans, and we wish to share our evidence that stem cells are safe and effective." Additionally, 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 adds, "In the last couple of years, evidence has come out that the cells we use reduce inflammation and pain, and help lubricate the joint. About 200,000 hip replacements are done every year in humans. That’s a very good target for someone to look at cell therapy."

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.

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."