Stem cell clinics have received great deal of negative press, with prominent media outlets announcing that the FDA mailed “Warning Letters” to stem cell clinics across the U.S. 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 United States. 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?
What this hype does not cover is the promising medical potential of stem cell therapies, nor does it properly credit the clinics that comply with FDA regulations to offer effective medical treatments to populations of patients that otherwise have limited options.
Should You Believe the Hype About Stem Cell Clinics?
Today, the large majority of medical clinics that off 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 be 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 extremely safe for patient use.
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 500 clinical trials are investing therapeutic uses of MSCs. Additionally, 300,000+ scientific publications about stem cells have been released.
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 off-shore regulatory bodies to offer stem cell procedures that are approved by local regulatory agencies.
Regulatory Oversight: What are 351 and 361 Products?
Currently, the FDA’s Center for Biologics Evaluation and Research (CBER) is responsible for regulating 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. 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.
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 “361” products.
To further complicate the situation, there was a major FDA Public Hearing held at the NIH on September 12-13th, 2016, that reviewed draft guidances pertaining to the regulation of Human Cell and Tissue-Based Products (HCT/Ps). When the final guidelines get released by the FDA this fall, it will play a critical role in clarifying stem cell procedures for stem cell clinics across the U.S.
Stem Cell Clinics in the U.S.
Below, we cover three stem cell therapy companies that maintain American-based facilities with U.S. Board Certified Physicians. Each has large populations of patients that they have treated with stem cells, and at least one (Regenexx) is maintaining a Patient Registry to document long-term patient outcomes. Please note that we are not advising patients to seek out these companies, but are identifying them so readers can speak to their experience with each.
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.
The Regenexx® technology involves a procedure in which a small bone marrow sample is extracted through a needle and a blood draw from a vein in the arm. These samples are then processed in a laboratory and the cells it contains injected into the area needing repair, with the goal of delivering large numbers of stem cells to the site of injury.
Regenexx also a licensed off-shore 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.”
Click here to read our fascinating interview with Dr. Christopher Centeno. Dr. Centeno 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 and share my experience here.
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.
The stem cell treatments are performed in their state-of-the-art surgical center under the care of board-certified doctors. Additionally, Okyanos is fully licensed and regulated under the Bahamas Stem Cell Therapy and Research Act, and adheres to U.S. surgical center standards. Okyanos maintains both a North American Office in Clearwater, FL, and a purpose-built Cell Therapy Surgical Center in Freeport, Grand Bahama.
Click here to access our recent interview with Matthew Feshbach, Co-Founder and CEO of Okyanos.
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.
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 United States to treat a variety of medical conditions.
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, respectively. Additionally, Celltex 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 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?
Most importantly, how was your experience getting a stem cell treatment?
Please share your answers in the comments below, so that other patients can make better, faster, and more informed decisions about their health.
 Aabb.org. (2017). Cellular Therapies. [online] Available at: http://www.aabb.org/advocacy/regulatorygovernment/ct/Pages/default.aspx [Accessed 1 Aug. 2017].