What Stem Cell Clinics Do You Trust ?
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.
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 investing 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 “361” products.
The Global Institute of Stem Cell Therapy and Research (GIOSTAR) “provides adult stem cell 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.
Source : https://goo.gl/Pv1t6Z