The biotech company Stemedica Cell Technologies has requested a pre-IND (investigational new drug) meeting with the U.S. FDA (Food and Drug Administration) for the purpose of discussing the use of Stemedica’s proprietary line of allogeneic adult stem cells as treatment for ischemic stroke.

Specializing in the R&D of adult stem cell therapies, Stemedical Cell Technologies has developed proprietary products composed of the type of adult stem cell known as mesenchymal stem cells (MSCs), which have already been shown in a number of independent studies to constitute a safe and efficacious therapeutic modality for a wide variety of injuries and diseases.

According to Nikolai Tankovich, M.D., Ph.D., president and chief medical officer of Stemedica, "Following a stroke, there is little therapy to offer patients to promote recovery other than physical, occupational, and speech therapy. Treatment with allogeneic mesenchymal bone marrow cells may offer new hope to patients with chronic neurological or age-related, neurodegenerative diseases." Indeed, since MSCs are known to be "immune privileged", "universal donor" cells, they pose no risk of immune rejection and therefore do not need to be administered autologously (in which the donor and recipient are the same person) but instead can be administered allogeneically (in which the donor and recipient are not the same person), as an "off-the-shelf" item.

The requested pre-IND meeting with the FDA is the preliminary step in the formal authorization process required before clinical trials can be initiated. According to Maynard Howe, Ph.D., vice chairmand and CEO of the company, "Stemedica’s facility will manufacture clinical grade stem cells as it prepares for FDA approval of an IND to begin clinical trials."

Incorporated in 2005 and headquartered in San Diego, Stemedica describes itself as a "specialty biopharmaceutical company" which, within the U.S., is "currently developing regulatory pathways for traumatic injury, stroke and wound repair." As further described on the company’s website, "Outside the United States, Stemedica provides its adult stem cells to hospitals and research centers that are conducting studies under protocols approved by the appropriate regulatory agencies. These studies are focused on the treatment of neurodegenerative disease, sight restoration and wound repair."

Adult stem cells are consistently proving to offer a viable and efficacious therapy for a number of diseases and injuries, especially in the treatment of neurodegenerative diseases such as Alzheimer’s, Parkinson’s, and Huntington’s disease, among others. Now, researchers have visually observed, in real time, the regenerative power of adult stem cells in a new animal model of Huntington’s disease.

Led by Dr. Yoram Cohen of the School of Chemistry at Tel Aviv University (TAU) in Israel, scientists used mesenchymal stem cells (MSCs) derived from bone marrow to treat animals in whom the disease had been artificially induced. In a novel approach to the study, Dr. Cohen and his colleagues also utilized "in-vivo MRI" (magnetic resonance imaging) to track the progress of the MSCs in the brains of the animals. The cinematic result clearly demonstrated the natural ability of the MSCs to target damaged or unhealthy tissue and repair the degeneration.

As Dr. Cohen explains, "By monitoring the motion of these cells, you get information about how viable they are, and how they can benefit the tissue. We have been able to prove that these stem cells travel within the brain, and only travel where they are needed. They read the chemical signaling of the tissue, which indicates areas of stress. And then they go and try to repair the situation."

The in-vivo MRI was conducted at the Strauss Centre for Computational Neuro-Imaging, where Dr. Cohen and his colleagues were able to observe, in real time, the activity of the live, active MSCs, which had been labeled with magnetic iron oxide nanoparticles, thereby allowing the MSCs to be tracked throughout the brain.

As Dr. Cohen further explains, "Cells that go toward a certain position that needs to be rescued are the best indirect proof that they are live and viable. If they can migrate toward the target, they are alive and can read chemical signaling." Additionally, he adds, "Bone marrow-derived MSCs bypass ethical and production complications, and in the long run, the cells are less likely to be rejected because they come from the patients themselves. This means you don’t need immunosuppressant therapy."

In actuality, since MSCs are "immune privileged", "universal donor" cells, they do not pose any risk of immune rejection even when they are not derived from the same patient to whom the cells are administered. In other words, there is no risk of immune rejection even when MSCs are administered allogeneically (in which the donor and recipient are not the same person), therefore autologous (in which the donor and recipient are the same person) administration is unnecessary, as is immunosuppressant therapy even when the MSCs are administered allogeneically.

Nevertheless, the results of the study offer further concrete evidence for both the natural "homing" ability as well as the powerful regenerative capacities of MSCs, especially in the treatment of neurodegenerative diseases for which conventional medicine currently offers no known treatment or cure.

At Jaslok Hospital in Mumbai, 55-year-old Bhawarlal Jain has received autologous adult stem cell therapy for the treatment of Parkinson’s disease. Mr. Jain has suffered from advanced symptoms of the disease for 6 years, which included spondylitis – inflammation of the vertebrae – and other joint pain since 2004. According to Jain, "I managed my business until my speech became so impaired that I had to repeat everything at least four times to be understood."

Then Mr. Jain came to Jaslok Hospital in February of this year, where a new clinical trial was being conducted in which ten Parkinson’s patients were being enrolled for autologous (in which the donor and recipient are the same person) adult stem cell therapy. In addition to enrolling in the study, Mr. Jain also became the first volunteer.

As he explains, "When I heard I was going to be the first human to be treated using stem cell transplant, I was excited and scared. I had told my family that I may never return." Ten days after receiving the stem cells, however, he is no longer afraid, and any doubts or trepidation that he may have had have now been replaced with optimism. As his wife, Sukhi, explains, "I was scared initially but now I am happy that we opted for this operation." As Dr. Pettarusp Wadia, a neurologist at Jaslok Hospital, adds, "All we did was tell him about the procedure and he volunteered himself."

Specifically, the procedure utilizes the type of adult stem cell known as mesenchymal stem cells (MSCs), which are harvested from each patient’s own bone marrow via the hip, and then returned to the patient therapeutically after being processed in the laboratory. According to Dr. Paresh Doshi, head of the team who performed the eight-hour-long procedure, "We chose the stem cells from the marrow of the patient’s hip bone as these cells are readily isolated. They can expand in culture and the body can accept them easily. Small quantities of these cells were injected at an interval of every one millimeter in his brain."

Although Mr. Jain is already showing significant improvement, he will continue to be monitored for the next 18 months.

A pro-embryo group has filed a lawsuit against the National Institutes of Health (NIH) alleging that the new stem cell policy of the Obama administration violates federal law. According to the members of the group, they filed the court case in order to protect embryos. In fact, one of the plaintiffs listed in the filing is named simply as "embryos".

The lawsuit was filed in federal district court in Washington, D.C. in a 28-page-long document. Besides "embryos", additional plantiffs include Dr. James Sherley, Dr. Theresa Deisher, and Nightlight Christian Adoptions, each of whom is listed "individually and as next friend for Plantiff Embryos". Shayne and Tina Nelson, William and Patricia Flynn, and Christian Medical Association are also listed as plaintiffs, but not as "next friend for Plaintiff Embryos".

Dr. Deisher is director of R&D at AVM Biotechnology in Seattle, and Dr. Sherley is currently an adult stem cell researcher at the Boston Biomedical Research Institute although he is perhaps best remembered as the former Massachusetts Institute of Technology professor who went on a hunger strike in 2007 in order to protest a lack of faculty diversity at M.I.T. after he was denied tenure. Nightlight Christian Adoptions is an organization which encourages adoptions of left-over embryos from fertility clinics.

The defendants are listed as Kathleen Sebelius, Secretary of the Department of Health and Human Services, in addition to the Department of Health and Human Serivces itself, and Dr. Francis Collins, director of NIH, in addition to NIH itself.

Complaints filed in the lawsuit assert that the new federal policy on human embryonic stem cell research enacted by the Obama administration violates the Dickey-Wicker amendment. According to Drs. Sherley and Deisher, federal guidelines "authorize public funding of research that depends upon and, indeed, requires the destruction of living human embryos."

In March of last year, Nightlight and others filed a similar lawsuit in the U.S. District Court in the state of Maryland. According to Tony Mazzaschi of the Association of American Medical Colleges in Washington, D.C., the new lawsuit doesn’t stand "a chance in hell" of succeeding.

(Please see the numerous related articles on this website, including but not limited to: "Obama Decrees Changes in Embryonic Stem Cell Research, Though Not What One Might Expect", dated March 9, 2009; "Obama Rescinds Bush-Era Executive Order Pushing for More Ethical Stem Cell Research", dated March 10, 2009; "Obama Signs Law Restricting Federal Funding of Embryonic Stem Cell Research", dated March 11, 2009; "A High-Profile Proponent of Embryonic Stem Cell Research Sharply Criticizes Obama’s Policy", dated March 13, 2009; "Members of The President’s Council on Bioethics Object to Obama’s Stem Cell Policy", dated March 26, 2009; "NIH Issues Guidelines Restricting Embryonic Stem Cell Research", dated April 17, 2009; "Embryonic Stem Cell Advocates Protest NIH Guidelines", dated May 25, 2009; "Pros and Cons of the New NIH Guidelines", dated June 3, 2009; "NIH Receives Nearly 50,000 Comments", dated June 5, 2009; "Obama Scraps Bioethics Council", dated June 17, 2009; "NIH Issues New Guidelines", dated July 7, 2009; "New Director of NIH Chosen", dated July 8, 2009; "New NIH Stem Cell Guidelines are Slowing Research", dated July 14, 2009; and "Clinical Results From Embryonic Stem Cells are ‘Decades Away’", dated July 15, 2009, among other articles).

If you are between the ages of 18 and 60, in good health, and would like to do a good deed, the "Be The Match" registry would like to solicit the donation of your adult stem cells.

Operated by the National Marrow Donor Program, the Be The Match registry is the largest in the world, arranging approximately 4,300 transplants a year. Although originally begun for bone marrow donations, the registry has now expanded to include adult stem cell donations, for which the process is relatively simple, quick, and provides a valuable, life-saving service to others.

Upon signing up, new registrants will receive a collection kit in the mail, with which a swab of cheek cells may be collected and returned to the registry. Those registrants who are identified as a potential match will then be contacted for further testing.

Of particular interest to the registry are the type of adult stem cells known as hematopoietic stem cells, which are found in umbilical cord blood, peripheral blood, and bone marrow. Umbilical cord blood is the most easily collected, as it can be cryogenically stored immediately after a child’s birth. Bone marrow donation is the most difficult to collect, since it must be surgically extracted under general anesthesia, a process which is contraindicated in many patients who are already weakened by age or disease. The collection of adult stem cells from peripheral blood is performed by a process known as apheresis, in which blood that is removed from one arm is passed through an apparatus that extracts the stem cells and then returns the remaining blood cells to the other arm.

Currently approximately 60% of the registry’s transplant procedures involve adult stem cells that are derived from peripheral blood, while 20% of the procedures use adult stem cells derived from umbilical cord blood, and the remaining 20% of the procedures involve bone marrow.

As described on the website of the registry, "Donors never pay for donating and are never paid to donate. All medical costs are paid by the patient’s medical insurance or by the patient, sometimes with assistance from the National Marrow Donor Program (NMDP)." Nevertheless, the website also adds that, "The total cost to add a new member to the Be The Match Registry is about $100. This includes the cost of the testing needed to match donors to searching patients and related costs."

Individuals interested in donating their cells to the registry, or in finding a match for their own medical needs, may obtain more information at www.marrow.org.

Nearly two years ago, Sheila Weiler suffered a stroke during childbirth which left her paralized on her left side. Now, she has decided to travel to Germany in order to receive autologous adult stem cell therapy which is not available in her home country, the United States.

In Germany, Sheila’s own adult stem cells will be harvested from her bone marrow through her hip, and after being purified and expanded in the laboratory the stem cells will then be placed directly into the damaged tissue of her brain.

As Sheila describes, "At first I thought it was a pipe dream and I would never really go and this would never really happen. With this I have an opportunity to show my children determination and inner strength and never to give up."

Although none of the reports about Sheila actually mention the particular clinic in Germany to which she will be traveling, odds are that she will probably be visiting the XCell-Center, which is a private institute for regenerative medicine that has clinics in both Dusseldorf and Cologne. The Center is becoming increasingly renowned for its use of adult stem cell therapies in the treatment of a wide variety of medical conditions, including stroke, and since its founding in 2007 the XCell-Center has treated more than 1,600 patients with autologous (in which the donor and recipient are the same person) adult stem cell therapy.

The XCell-Center strictly uses only adult stem cells. At no time are embryonic stem cells ever used in any of the Center’s therapies. As described on their website, "The XCell-Center treats patients with their own autologous adult stem cels. It is the first private institute worldwide to hold an official license for the extraction and approval of stem cell material for autologous treatment." As further described on their website, "…therapy with embryonic stem cells is strictly prohibited in Germany. At the XCell-Center, we only use the patient’s own stem cells for therapy. … Because our adult stem cell treatments use stem cells harvested from the patient’s own body (autologous cells), there are no ethical or moral concerns."

As in the U.S., autologous adult stem cells are classified as "drugs" in Germany, and therefore require government approval before they can be used in any clinical treatment. Unlike in the U.S., however, German law makes a distinction between "drugs" of individual origin that are for personal use, and drugs that are manufactured by the pharmaceutical industry for large-scale commercialization. As explained on the website of the XCell-Center, "The use of endogenous adult stem cells is ethical and legally straightforward. Under German law, the extracted stem cells are categorized as drugs. Because they are exclusively for personal use, they are individual drugs, and under German law do not require the same governmental approval as other drugs. Despite this, the clinic still has to obtain a manufacturing license from the surveillance authority."

A "manufacturing license" is significantly different from the decade-or-longer, multi-million dollar, multi-phase clinical trial process in the U.S. to which all new "drugs" must be subjected before they can receive FDA approval. Currently in the U.S., even an individual’s own, personal, autolgous adult stem cells are required to be scrutinized by the exact same bureaucratic system to which pharmaceutically manufactured drugs are subjected, which involves a lengthy and outdated process that typically takes a decade or longer and costs the sponsoring company hundreds of millions of dollars.

If U.S. federal laws were different, and if autolgous adult stem cell clinics could be set up in the U.S. merely by obtaining a "manufacturing license", as such clinics in Germany are allowed to do, then U.S. citizens such as Sheila Weiler would not be forced to leave their own homeland to travel to foreign countries in order to receive a type of adult stem cell therapy which is not available in the United States but which was, in fact, pioneered in the United States.