The Commercialization of Stem Cells: Promises and Public Concerns



The hype and hope of stem cell clinical trials


In several of the modules (e.g., Module 8), potential medical applications of stem cell (SC) science are discussed. Scientists are eager to discover and test emergent technologies, ultimately applying them to the treatment of human diseases. The public, in turn, is eagerly anticipating breakthroughs in SC research that will provide the hoped-for alternative to our current reliance on drugs, devices, and procedures. This reliance often involves high cost, need for chronic use, waning efficacy and, importantly, side-effects that can range from minor nuisances to life-threatening complications. While many are hoping for near-miraculous benefits, even cures, offered by the promise of stem cell therapies, it is very necessary to be realistic and tamp down the incessant hype, as any cure will not be realized for many years.

There are other cutting edge approaches that also show promise including genetic, proteomic, and metabolomic-based applications to therapeutics. All these pioneering approaches will need to be developed and clinically tested which inevitably will take several years to complete. Yet these will be exciting years filled with promising discoveries as we translate basic biology into regenerative medicine.

There are urgent questions that confront us having to do with the application of SCs to medicine which include:
  • When and how will discoveries from in vitro and animal model studies of SCs as well as computer simulation (in silico), translate into therapies for human beings?
  • What kind of specific proof must be presented before clinical trials using embryonic SCs or adult SCs are allowed to begin?
  • How do we remain guided by stringent ethical principles and the soundest science, yet also be willing to think innovatively and at times question or even reject accepted wisdom?

The two videos below offer a response to the questions raised above. They illustrate how high levels of clinical and scientific expertise, innovative thinking, and solid animal model studies may converge to bring us closer to the day when stem cell transplants may, in this case, help heal spinal cord injury and reduce paralysis.

Irving Weissman, MD (b. 1939)


In the first video, we see Irving Weissman, MD, Director, StemCells, Inc., discuss stem cell research and its impact on neurological conditions. In the accompanying video, we see mice with spinal cord injury: pre, post treatment, control mouse vs. stem cell-treated mouse.






Before any intervention is approved for study we need to respond to the urgent questions we raised to see if the stem cell therapy truly has promise and, if so, how exactly the therapy must be delivered to offer optimal benefit. Especially, when sufficient proof of efficacy and safety are lacking, we must remain wary of the few clinicians - from the well-meaning to the unscrupulous, here and abroad – who may offer unproven treatments to desperate patients who are willing to pay huge sums in hopes of obtaining a benefit.
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Recent stem cell (SC) trials that have raised important questions for clinical research


Breaking news about important new developments involving research and discovery on stem cells arrives almost weekly (see Current News in Stem Cell Research). Often, the emergent research results raise significant bioethical issues.

Our first research example underscores how scientific enthusiasm for cutting-edge research can be difficult to moderate, even in the face of major adverse events. In this case of stem cell breast cancer research discussed below, many patients were harmed despite the required orderly and comprehensive procedures in place to develop and conduct the trials.

Research Example 1: Beginning in the 1980’s, in unrelated trials, many women with advanced metastatic breast cancer consented to a protocol based on high-dose chemotherapy (HDC) followed by bone marrow (autologous hematopoietic) stem cell transplantation (HCT). (This procedure therefore sometimes is called HDC/HCT therapy; HCT is elsewhere called ASCT (autologous stem cell transplantation).

When the trials began, bone marrow transplant appeared to be a promising intervention, one of the few to offer a glimmer of hope to women with advanced disease. After several years, however, extensive statistical analyses made it increasingly clear that a disproportionate number of women in these HDC/HCT trials had died and many others suffered “severe harms” without experiencing survival benefits (Howard et al., 2011; Berry et al., 2011 a and b; and Droste et al., 2011).

In addition, a key study that had pointed to the effectiveness of high-dose chemotherapy and bone marrow transplants in treating metastatic breast cancer was based on data that were falsified. The American Society of Clinical Oncology announced that data published by an unscrupulous South African researcher, Dr. Werner Bezwoda, had led thousands of women with breast cancer to undergo expensive, debilitating, and often fatal bone marrow transplants. His data suggested the controversial procedure was more effective than it actually was. The so-called Bezwoda fraud, in which HDC/HCT trial procedures, data, and reported results were falsified, as well as other negative developments, stigmatized the HDC/HCT breast cancer treatment approach (see for example Hagmann 2000). Yet despite acknowledgement of the Bezwoda fraud and more importantly, repeated negative trial results, clinicians who believed in this procedure were slow to discontinue it (Maugh and Mestel, 2001).

In studying HDC/HCT, Howard and colleagues (2011) concluded that
“..results suggest that comparative effectiveness research studies that report negative results can reduce [research] spending, but specialists may be reluctant to relinquish cutting-edge technologies. This bias in favor of pursuing advanced science even when clinical benefits are absent and harm may occur, on the part of even ethical and dedicated scientists, is a common feature of biomedical research that scientists and ethicists must grapple with.”

Recent studies from Dr. Irving Weissman’s group in Stanford presented data that the reason why these trials were unsuccessful was the failure to remove cancerous cells from the bone marrow before transplantation. In their clinical study, they first purified all the hematopoietic stem cells from the patient’s bone marrow. They then gave the patients high doses of chemotherapy and reconstituted their immune system with the bone marrow transplant. They reported increased patient survival and speculated that by purifying the hematopoietic stem cells, they removed any bone marrow-derived tumor cells that may be present (Müller et al. 2012). Thus, new scientific research can at times lead to a re-examination of "failed therapies" such as HDC/HCT. Work such as that presented by Dr. Weissman's group demonstrates how HDC/HCT can be made safer and more effective.
Research Example 2: When a stem cell clinical trial looks promising, circumspection, as well as potential excitement is warranted. Many clinical trials begin with a small number of participants and have low statistical power to assess real clinical efficacy and identify health risks associated with the procedure. Results of a recent pilot study conducted by Bolli and colleagues offer the news everyone has been hoping for in stem cell research and medicine (Hellerman, 2011; Bolli et al., 2011). Beginning in 2009, sixteen patients with severely compromised cardiac function due to massive heart attacks (myocardial infarctions) were enrolled in a Phase I clinical trial in which the experimental protocol consisted of an infusion of 90% autologous stem cells cultured from their own heart tissue. Cardiac stem cells exist in the heart, but in insufficient numbers to develop into blood vessels and heart muscle – i.e., spontaneous large scale tissue repair - to restore normal function after a myocardial episode. Patients receiving a massive infusion of their own cardiac stem cells grown in the laboratory, however, showed strong improvement, beyond that seen with conventional medical therapies according to Bolli et al. Patients in the Bolli trial continue to be followed. Circumspection and excitement at these positive results are certainly warranted; however, as this was a small pilot study, further follow-up is needed to see if the reported gains will be enduring.
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Patient expectations and hopes


Patients desperate for cures will often place their hope in treatments or trials offered in the US or abroad that are not FDA-approved. In the U.S., medicine and medical research can be conservative and move slowly, often too slowly for many people in need. The medical establishment viewpoint is not infallible. Patients and their families and advocates have contributed by focusing attention on innovative alternatives, for example, as famously detailed in movies and popular accounts (e.g., Lorenzo’s Oil - see www.myelin.org/lorenosoil/ for more information) or the parallel tracks developed for HIV therapies in the 1980s. Patient advocates are now more often invited to participate as peers alongside medical scientists in reviewing grants, presenting at medical and research conferences, and as partners in innovative stem cell and other medical research.

Clinical trial for myelofibrosis that targets cancer stem cells



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Stem cell medical tourism


Other regions of the world – in particular Asia (including India, China, Thailand), Eastern Europe and Russia, the Caribbean (Dominican Republic), and Israel – offer stem cell interventions not available in the US. Clinicians there often claim efficacy for a wide range of conditions. Treatment in these countries is substantially less expensive than in the United States. In some of these countries treatment can be substandard, as regulations and oversight may be much weaker than what is required in the U.S. Patients who develop medical problems as a result of participating in foreign “therapies” may have little recourse - medically or financially - either abroad or upon their return to the U.S.

From a regulatory perspective, currently there is no U.S. regulation that prevents individuals from seeking and using treatments from abroad. Information available on the Web sites of the NIH, FDA, CDC, and related sites is designed to educate the public and to try to dissuade them from seeking unapproved and possibly dangerous or - at a minimum - useless therapies. Yet what should a person with a disability make of the many glowing testimonials from those who have spent a great deal of money to obtain these unapproved “treatments,” and who proclaim, on Web sites of the clinics they have visited or elsewhere, that they have substantially improved or even been cured? It is very rare for any of these individuals to be followed over time, so it is not possible to see if the purported benefits hold up.

Physicians and medical scientists increasingly are asked about going abroad for stem cell therapies. Sometimes, individuals’ physicians may not be asked, as patients anticipate professional opposition from their doctor. One cannot discount that bona fide stem cell science is being conducted in some of the countries where questionable commercial applications also occur. As an example, see the supplement published by the journal Science entitled Regenerative Medicine in China, April 2012, in which several articles detail a wide range of presumably reputable stem cell research and treatments derived from such research.


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(Source: Medra.com)

Stem cell treatments abroad

Web sites listing opportunities to obtain stem cell “treatments” abroad are widely available, such as:












Purported “Successful” Stem Cell Patient Videos





Even some stem cell clinics in the U.S. offer glowing testimonials stating that a person heretofore not helped by available interventions elsewhere has miraculously responded to stem cell infusions at their facility. How can we properly and effectively educate our population about the false hopes and claims by these “stem cell clinics”?

On the other hand, as described in the account below of Texas Governor Rick Perry’s quest to bring stem cell therapies to Texas, some medical facilities abroad may be pioneering stem cell procedures that may – or may not - be performed in the future in the US.

To be acceptable in the US, the foreign procedures first will have to be studied in clinical trials and, if found safe and effective, FDA approval will be granted. Without this testing, people, many of whom are desperate, will continue to go abroad.

Governor Rick Perry and Stem Cell Treatment


Rick Perry We report on one recent, striking example of how media reporting about stem cells may come to have a considerable influence on public perceptions of stem cell treatments, and may influence legislative, fiscal, and commercial decisions, as well as patient wishes and actions: In early August, 2011, the media reported that Gov. Rick Perry of Texas, a former Republican candidate for president in 2012, had had a procedure in which his own cultured stem cells had been infused into him for a back problem (see Ramshaw 2011).

Gov. Perry was reportedly very enthusiastic about the procedure and its outcome, performed by a Houston-based orthopedist and personal friend of the governor who had never previously performed this procedure. Gov. Perry also has become a vocal advocate for the procedure, and since Perry’s stem cell infusion, the Texas Medical Board— mostly at the behest of the governor and the orthopedist, a Dr. Jones — has reviewed how to regulate this adult stem cell procedure in Texas.

Gov. Perry has publicly expressed his conviction that SC treatments can be very effective, and that Texas should be a leader in promoting SC treatments. In this case, Gov. Perry’s story, and advocacy, has led to the increased establishment of more commercial stem cell enterprises in that state.

The article in the NY Times by S.M. Nir (2011) reported that immediately before the Texas Medical Board meeting, Perry in effect lobbied them, via a letter to the Board chair, promoting the economic and medical potential of adult stem cells. In the letter, Gov. Perry reportedly asked Board members to recognize “the sound science and good work that is already being done,” as they considered new regulations.

Gov. Perry did not reveal at the time, according to Nir’s article, that he’d undergone an experimental injection of his own stem cells. The Board may not have known that this therapy isn’t FDA approved, has mixed evidence of success, and can be very costly (tens of thousands of dollars). Dr. Jones, who became a stem cell tourist himself, and had been treated – Jones asserts successfully - with adult SCs in Korea for his own debilitating arthritis, reportedly contacted Mr. Perry to tell him, “I’m in Korea seeing miracles, and something needs to be done for our fellow Americans” (Nir, 2011).

It is probable that given the media coverage of this episode, Gov. Perry’s actions, as well as the actions of the Texas Medical Board, a number of outcomes are possible. Texas may see increased commercialization and activity of adult stem cell clinics and increased demand by patients in Texas and beyond and possibly other sequelae. All for a still FDA-unapproved procedure that will be costly for many and without a guarantee of success.


Zarzeczny et al. (2010) and others document that patients obtaining stem cell treatments from abroad spend between $5,000 to about $40,000 out of pocket, with an average cost of about $22,000 (Regenberg et al., 2009). Further, almost none of the treatments offered have been evaluated in clinical trials.

Zarzeczny et al. (2010) focus their discussion on how media coverage about stem cells shapes public perceptions and discussion, and influences the desire of desperate patients and their families to want to access these questionable treatments at for-profit clinics. They further assert that news media shape the SC discussion in two major ways:
For one fairly typical account of a family going to India at great expense to obtain an unproven stem cell treatment for their child, see this CNN report and video: "Family hangs hope for boy on unproven therapy in India" (via CNN.com).

  • they call attention to specific issues, events or developments regarding stem cell science and medicine, which has the effect of shaping the public agenda and of heightening the attention patients will pay to reported developments
  • news media frame the discussion of such medical topics, often over-simplifying and reducing the complexity and uncertainty inherent in medical science





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Commercial applications of stem cell therapies


Regenerative medicine for elite athletes: Therapy or an unfair advantage?

Professional athletes can afford to try expensive and unproven therapies; most people cannot. Further, given all the anti-doping scandals in professional sports over recent decades, soon there will have to be a discussion concerning whether types of tissue-regenerative treatments always are truly medical. At the least, stem cell treatments might be seen as providing unfair advantage for some players. Does this mean all athletes with similar sports medicine injuries should seek stem cell therapy? What if it works for some players and not others?

140px-Bartolo_Colón_2011.jpg
In March 2010, Yankees pitcher Bartolo Colón received a transplant of stem cells to repair damaged tissues in his right shoulder. The nature of this treatment is being investigated by Major League Baseball. During the 2011 season, Colón had an 8 and 9 record with an earned run average (ERA) of 3.63.

This article at Smart Planet, quoting New Scientist, states that Colón’s athleticism is not now abnormal, therefore, use of stem cells – in this case to re-grow or heal an injured tendon – is medically appropriate and does not constitute an unfair advantage. However, the article notes that some potential uses might in the future be questionable. The article further notes that equine athletes (i.e., race horses) with damaged tendons - whose high and often fatal U.S. breakdown rate has been the subject of much news in 2012 – subsequently heal the tendons much better with stem cell treatment than with conventional veterinary therapies (repeat tendon injury rate of approx. 27% vs. 50-60%; Jabr (2011)).


Commercial supplements promoted for tissue regeneration


Some companies now promise that consuming their supplements will result in more proliferation of endogenous stem cells and will stimulate tissue regeneration. Some examples of these companies are:


This online course will not attempt to assess the claims made on these sites. Rather, we just point out that to date, there is no formal scientific proof that these supplements do what is claimed. Appropriately controlled, peer reviewed and approved research into the substances and their purported benefits is mostly absent but definitely needed.
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Questions needing answers when evaluating stem cell clinic treatment claims


Many critical questions that need to be answered before we can have any possibility of assessing the medical appropriateness, safety, and possible efficacy of the SC treatments offered by these clinics, include those stated by Barrett (2010):
  • How credible are their claims?
  • How are the stem cells prepared?
  • How, and where in the body, are stem cells introduced?
  • Are steps taken to insure that the stem cells would not lead to infection or tumor formation?
  • How was it determined that patients experience no side effects from the treatment(s)?
  • Do the doctors’/clinics’ theories and methodology make sense and hold up?

Other questions that need to be considered:
  • In what quantities are the stem cells transplanted/transfused?
  • Was there systematic follow-up of long-term outcomes?
  • Where have the clinic directors published their clinical and/or research results?
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Cord blood banking


Another area of commercial activity with respect to stem cells is cord blood banking – the practice of storing stem cells from a newborn’s umbilical cord, for potential future use by the child, family members, or others. See the following examples:


Couples giving birth in many hospitals now often will be approached about banking their newborn’s cord blood – for themselves, their child, or for research. Those seeking to bank cells for their own possible future ills may be looking at initial fees of around $2,000, plus non-trivial monthly fees for ongoing storage (see for example, Cordblood's Pricing Schedule). In some foreign countries such as India, cord blood also is emerging as a huge commercial enterprise.

It certainly is possible that banking cord blood may help people heal illnesses in the future. There are medically significant emerging applications. The compelling case described in the box below describes how cord blood banking can be especially lifesaving in the search to find stem cell matches for Africans and people of African descent.

There also may be some benefits to retrieving stem cells from baby teeth for future therapies. Stem cells that can be obtained from juvenile and even adult molars, particularly the lower third molar, also are being looked at for future banking potential (Oda et al., 2010).

Suggesting today, however, that all parents of newborns bank cord blood seems premature and commercially motivated, well before the science is in place to suggest specifically how the banking can be useful in the future. In this sense, cord blood banking is much like banking of ova for a possible future child, something that is also becoming a big business (see for example Ethical Considerations of Egg Donation; and "
So Eager for Grandchildren, They’re Paying the Egg-Freezing Clinic" in the New York Times).

Innovative use of cord blood


One very positive report of the innovative use of cord blood is the following: "Finding a Match, and a Mission: Helping Blacks Survive Cancer"

“Umbilical cord blood is even more useful than bone marrow, because its stem cells are “more tolerant,” Dr. Rubinstein said. They have survived fewer bacterial and viral assaults and are less likely to counterattack with graft-versus-host disease.”

Seun Adebiyi, a Yale Law School graduate, struggled to find a marrow donor after learning he had two blood cancers. A Nigerian woman in the U.S. had donated her baby’s umbilical cord blood to a “cord-blood bank.” Its stem cells were a close enough match, and Adebiyi is now in remission after receiving the stem cells. In February 2012, he helped start Nigeria’s national bone-marrow registry, the first in Africa outside South Africa, and he is now raising money to start a cord-blood bank there. These banks eventually will help many Africans and African Americans with cancer who often cannot locate a marrow or stem cell donor.

Source: "Finding a Match, and a Mission: Helping Blacks Survive Cancer" (New York Times, May 11, 2012)

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How many stem cell samples will we need for widespread therapeutic use?

We do not know exactly how many stem cell lines are required to create a stem cell bank that would be adequate to meet the needs of a given population. At a recent 2012 conference on Stem Cells held in Edinburgh, Scotland, Dr. Shinya Yamanaka calculated that only about 50 unique HLA homozygotes would match 73% of a highly homogeneous Japanese population for potential use of stem cell therapies. It is not clear how many stem cell lines would be needed in the US which has a very heterogeneous ethnic population.

Thought question

Given what has been stated here about the potential benefits of cord blood banking, if stem cell medicine advances as hoped for, and cord blood or other stem cell banking therefore becomes commonplace, should banking of stem cells be covered by health insurance? What ethical problems might be caused by insurance covering cord blood banking?


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Conclusion


To advance science and medicine, study outcomes must be peer-reviewed and shared, transparently, as much as possible. Purported treatments that have not been studied scientifically in the ways discussed throughout this online course, and particularly detailed in Supplement 6, should be regarded with skepticism. But keep in mind, many treatments, including some very common ones with multiple benefits, such as aspirin, have never been studied using the gold standard randomized controlled trials. It is unfortunate that there will never be enough research money to study all the potential stem cell “treatments” that need to be evaluated for safety and efficacy.

Many news articles now and in the future will trumpet the promise or supposed successes of stem cells used for medical purposes. The public needs far more education about stem cell science and medicine in order to better evaluate the accuracy of these reports. Only when clinics with established reputations report on the successful use of stem cell therapies in reputable journals should patients have the confidence to try such therapies. History has taught us that even apparently legitimate, sincerely reported stem cell therapies will still require years of clinical testing with continual demonstration of safety, efficacy, and long-term documentation of potential side effects before these therapies might confidently and more universally be offered as a standard of care.


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References



  • Barrett S (2010). The Shady Side of Embryonic Stem Cell Therapy. Essay published at http://www.quackwatch.org/06ResearchProjects/stemcell.html. Accessed June 20, 2012.
  • Berry DA, Ueno NT, Johnson MM, Lei X, Caputo J, Rodenhuis S, Peters WP, Leonard RC, Barlow WE, Tallman MS, Bergh J, Nitz UA, Gianni AM, Basser RL, Zander AR, Coombes RC, Roché H, Tokuda Y, de Vries EG, Hortobagyi GN, Crown JP,Pedrazzoli P, Bregni M, Demirer T (2011a). High-dose chemotherapy with autologous stem-cell support as adjuvant therapy in breast cancer: overview of 15 randomized trials. J Clin Oncol. Aug 20;29(24):3214-23.
  • Berry DA, Ueno NT, Johnson MM, Lei X, Caputo J, Smith DA, Yancey LJ, Crump M, Stadtmauer EA, Biron P, Crown JP, Schmid P, Lotz JP, Rosti G, Bregni M, Demirer T (2011b). High-dose chemotherapy with autologous hematopoietic stem-cell transplantation in metastatic breast cancer: overview of six randomized trials. J Clin Oncol. Aug 20;29(24):3224-31.
  • Bolli R, Chugh AR, D'Amario D, Loughran JH, Stoddard MF, Ikram S, Beache GM, Wagner SG, Leri A, Hosoda T, Sanada F, Elmore JB, Goichberg P, Cappetta D, Solankhi NK, Fahsah I, Rokosh DG, Slaughter MS, Kajstura J, Anversa P (2011). Cardiac stem cells in patients with ischaemic cardiomyopathy (SCIPIO): initial results of a randomised phase 1 trial. Lancet Nov 26;378(9806):1847-57. Nov 14. [Epub ahead of print]
  • Droste S, Herrmann-Frank A, Scheibler F, Krones T (2011). Ethical issues in autologous stem cell transplantation (ASCT) in advanced breast cancer: a systematic literature review. BMC Med Ethics. Apr 15;12:6.
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  • Hagmann M (2000). Cancer researcher sacked for alleged fraud. Science 17 March 287 (5460): 1901-1902.
  • Hellerman C (2011). Studies: Stem cells reverse heart damage. CNN.com November 14. http://www.cnn.com/2011/11/14/health/stem-cells-heart-damage-reverse/index.html?hpt=hp_c3 Accessed June 20, 2012.
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  • Jabr F (2011). Stem cell therapy wasn't unfair help for baseball star. New Scientist 08 June, Issue 2816. http://www.newscientist.com/article/mg21028163.700-stem-cell-therapy-wasnt-unfair-help-for-baseball-star.html Accessed June 20, 2012.
  • Maugh TH, Mestel R (Los Angeles Times Medical Writers) (2001). The Los Angeles Times April 27. http://articles.latimes.com/2001/apr/27/news/mn-56336 Accessed June 20, 2012.
  • McNeil DG (2012). Finding a match, and a mission: Helping blacks survive cancer. The New York Times May 11. http://www.nytimes.com/2012/05/12/health/a-match-and-a-mission-helping-blacks-battle-cancer.html?_r=1&hp Accessed May 15, 2012.
  • Müller AM, Kohrt HE, Cha S, Laport G, Klein J, Guardino AE, Johnston LJ, Stockerl-Goldstein KE, Hanania E, Juttner C, Blume KG, Negrin RS, Weissman IL, Shizuru JA (2012). Long-term outcome of patients with metastatic breast cancer treated with high-dose chemotherapy and transplantation of purified autologous hematopoietic stem cells. Biol Blood Marrow Transplant. Jan;18(1):125-33. Epub 2011 Jul 20.
  • Nir SM (2011). Rick Perry has stem cell procedure, then works to bring it to Texas. The New York Times. 4 August 7:24 pm. http://thecaucus.blogs.nytimes.com/2011/08/04/rick-perry-has-stem-cell-procedure-then-works-to-bring-it-to-texas/ Accessed June 20, 2012.
  • Oda Y, Yoshimura Y, Ohnishi H et al. (2010). Induction of pluripotent stem cells from human third molar mesenchymal stromal cells. The Journal of Biological Chemistry September 17; 285:29270-29278.
  • Ramshaw E. (2011). Perry's adult stem cell treatment was doctor's first attempt. August 4. The Texas Tribune. http://www.texastribune.org/texas-people/rick-perry/perrys-stem-cell-treatment-was-doctors-first-attem/
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