Stem cell clinics have received a great deal of negative press, with prominent media outlets announcing that the FDA mailed “Warning Letters” to stem cell clinics across the United States. According to a paper published in the journal Cell Stem Cell in June 2016, at least 351 businesses offer “unproven” stem cell interventions from clinics spread across the U.S. Shortly after publication, the MIT Technology Review and Washington Post picked up the story, spreading the fear far and wide. Journalists then got enthralled with the story, calling it the “Wild West” of stem cells. But, is this the whole story?
Stem Cell Clinics
In this article:
- Should You Believe the Hype About Stem Cell Clinics?
- Stem Cell Differentiation Capacity
- Therapeutic Promise of Stem Cells
- Legitimate Stem Cell Clinics
- Regulatory Oversight: What are 351 and 361 Products
- Clinical Trials for FDA Products
- Top Stem Cell Clinics
FDA Approved Stem Cell Clinics
What this hype does not cover is the promising medical potential of stem cell therapies, nor has it properly credited the clinics that comply with FDA regulations to offer effective medical treatments to populations of patients who otherwise have limited options.
Should You Believe the Hype About Stem Cell Clinics?
Today, the large majority of medical clinics that offer stem cell treatments administer mesenchymal stem cells (MSCs), which they source from fat (adipose tissue) or bone marrow. Mesenchymal stem cells are a type of multipotent stem cell that is administered for a range of medical applications, including orthopedic repair, pain management, arthritis, asthma, and more. When properly administered, multipotent self-derived stem cells (such as MSCs) can be safe for patient use.
Stem Cell Differentiation Capacity
It is important that the cells be multipotent (limited in their differentiation capacity), rather than totipotent (can become any cell) or pluripotent (can become most cells). There is also an additional level of safety that comes from having the stem cells be self-derived, which doctors and scientists call “autologous.” Stem cell differentiation capacity is explained below:
- Totipotent stem cells – Have the capacity to form an entire organism
- Pluripotent stem cells – Can give rise to most, but not all, tissues within an organism
- Multipotent stem cells – Undifferentiated cells that are limited to giving rise to specific populations of cells
Therapeutic Promise of Stem Cells
While it is true that many stem cell clinics are not properly regulated, the therapeutic promise of stem cells is also clear. Today, nearly 30,000 scientific publications highlight research and therapeutic advances with mesenchymal stem cells (MSCs) and approximately 850+ clinical trials are investigating therapeutic uses of MSCs. Additionally, 300,000+ scientific publications about stem cells have been released.
Legitimate Stem Cell Clinics
This momentum is not surprising, because “We are not made of drugs, we are made of cells.” However, the biggest issue with the hype surrounding stem cell clinics is that it does not give proper credit to the companies that cooperate with regulatory bodies to ensure a safe and efficacious patient experience. Many of these companies also collaborate with offshore regulatory bodies to offer stem cell procedures approved by local regulatory agencies.
Regulatory Oversight: What are 351 and 361 Products?
The FDA’s Center for Biologics Evaluation and Research (CBER) regulates human cell and tissue-based products in the U.S., known as “HCT/Ps.” The FDA has two different paths for cell therapies based on relative risk. These pathways are commonly called “361” and “351” products. The 361 products that meet all the criteria in 21 CFR 1271.10(a) are regulated as HCT/Ps and are not required to be licensed or approved by the FDA. These products are called “361 products” because they are regulated under Section 361 of the Public Health Service (PHS) Act.
Clinical Trials for FDA Products
In contrast, if a cell therapy product does not meet all the criteria outlined in 21 CFR 1271.10(a)), then it is “regulated as a drug, device, or biological product under the Federal Food, Drug, and Cosmetic Act (FDCA) and Section 351 of the PHS Act.” These “351” products require clinical trials to demonstrate safety and efficacy in a process that is nearly identical to that what is required for pharmaceutical products to enter the marketplace. Stem cell clinics must ensure that their treatments meet the FDA’s criteria to be classified as “351” products.
Top Stem Cell Clinics
Below, we cover five leading stem cell clinics. Each one has treated large populations of patients with adult stem cells. At least one (Regenexx), is maintaining a Patient Registry to document long-term patient outcomes. We are not advising patients to seek treatments from these companies. We are identifying them to allow readers to seek out more information.
1. Stem Cell Institute (Panama)
Stem Cell Therapy for MS
One of their most recent studies exhibited the clinical feasibility of stem cell therapy as a safe and effective treatment approach for patients with multiple sclerosis (MS). Published in the Journal of Translational Medicine, the study showed that umbilical cord stem cells can slow down MS disease progression and decrease the frequency of flare-ups. However, these stem cells did not exhibit the ability to repair damaged nerve cells or myelin sheaths.
Clinical Trials Results
After the completion of this clinical study, there was an improvement in MS patient disability. The 1-month mark of the study documented improvements in mobility, hand, bladder, bowel, and sexual functions. Importantly, the study demonstrated that a sustained one-year umbilical cord stem cell therapy has more durable benefits than current MS drug therapies.
Headquartered in Denver, CO, Regenexx offers self-derived (autologous) same-day stem cell treatments to patients with orthopedic injuries and conditions. Regenexx clinics incorporate a variety of regenerative approaches, drawing patients from all over the U.S. who are seeking innovative, non-surgical treatments.
Regenexx Stem Cell Technology
The Regenexx® technology involves a procedure in which a small bone marrow sample is extracted through a needle and a blood is drawn from a vein in the arm. These samples are then processed in a laboratory and the cells they contain are injected into the area needing repair, with the goal of delivering large numbers of stem cells to the site of injury.
Beyond FDA Approved Cell Therapy
Regenexx also a licensed offshore clinic in the Cayman Islands where patients can undergo treatments that utilize laboratory expanded (“ex vivo”) stem cell populations. This approach allows for a much larger number of stem cells to be administered to the patient than is supported by U.S. law, which currently prohibits laboratory procedures that the FDA considers to exceed “minimal manipulation.”
CEO and Regenexx Reviews
Dr. Christopher Centeno is the Founder and CEO of Regenexx. He is a global authority in the culture expansion and clinical use of adult stem cells to treat orthopedic injuries and the visionary behind the Regenexx® technology. I am also a Regenexx patient. Click here to read my experience.
Founded in 2011, Okyanos is a stem cell therapy provider that specializes in treating patients with congestive heart failure (CHF) and other chronic degenerative conditions. Okyanos Cell Therapy uses internationally-approved technology to deliver a mixed population of fat (adipose) derived stem and regenerative cells (ADRCs) to patients with conditions such as cardiovascular disease, orthopedic issues, neurological disorders, urological indications, and autoimmune conditions.
Stem Cell Treatment Centers
Okyanos maintains both a North American Office in Clearwater, FL and a purpose-built Cell Therapy Surgical Center in Freeport, Grand Bahama. Okyanos’ stem cell treatments are performed in their state-of-the-art surgical centers under the care of board-certified doctors. Okyanos is also fully licensed and regulated under the Bahamas Stem Cell Therapy and Research Act, and adheres to U.S. surgical center standards. Click here to access our recent interview with Matthew Feshbach, Co-Founder and CEO of Okyanos.
4. GIOSTAR Mexico
The Global Institute of Stem Cell Therapy and Research (GIOSTAR) “provides adult stem cells for autologous and allogeneic stem cell therapy to patients around the world, based on research by Dr. Anand Srivastava.” It offers adult stem cells for rejuvenation treatment, muscular injuries and degenerative diseases. Each of GIOSTAR’s clinics is licensed for the application of stem cell therapy. Since 2000, its team of scientist and clinicians have been involved in the development and utilization of stem cell-based clinical protocols for stem cell therapy. Although the company is headquartered in San Diego, California, GIOSTAR Mexico has provided stem cell therapy to patients from all over the world. Mexico’s regulation of stem cell therapeutics differs from the regulations imposed by the U.S. FDA, making it a growing site for medical tourism.
Celltex specializes in cryopreserving mesenchymal stem cells (MSCs) for therapeutic use. Celltex acquires stem cells by collecting a small fat sample from a patient, from which MSCs are extracted, isolated, multiplied and stored for future use (known as cell banking). Patients can then use their stored stem cells for regenerative purposes through infusions or injections performed by a licensed physician.
FDA Approved Stem Cell Clinical Trials
Because the FDA considers an individual’s stem cells a drug if they have been expanded in large quantities, Celltex has begun the process of undertaking clinical trials in which it will seek approval from the FDA to provide stem cells for use by physicians in the U.S. to treat a variety of medical conditions.
Approved Stem Cell Therapies in Mexico
Nonetheless, to meet the immediate needs of its clients, Celltex has taken steps to comply with the regulations established by the FDA and COFEPRIS, the Mexican equivalent of the FDA for exporting and importing MSCs. Celltex also works with established, certified hospitals in Mexico, where independent, licensed physicians make it possible for Celltex’s cell-banking clients to receive their own cells for therapeutic purposes.
Have You Had a Stem Cell Treatment?
While the information above is important to understand from a scientific and regulatory perspective, patient experiences are valuable too. Have you had a stem cell treatment? What stem cell clinic did you use? What treatment did you get and for what condition? Share your answers in the comments below, so that other patients can make more informed decisions.
BioInformant is the first and only market research firm to specialize in the stem cell industry. BioInformant research has been cited by major news outlets that include the Wall Street Journal, Nature Biotechnology, Xconomy, and Vogue Magazine. Serving Fortune 500 leaders that include GE Healthcare, Pfizer, and Goldman Sachs. BioInformant is your global leader in stem cell industry data. Footnotes  Aabb.org. (2017). Cellular Therapies. [online] Available at: http://www.aabb.org/advocacy/regulatorygovernment/ct/Pages/default.aspx [Accessed 1 Aug. 2017].