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FDA 2020-11-03T19:22:15+00:00

FDA Approval of Stem Cell Therapy

Patients frequently ask if PRP treatments and stem cell therapy have been approved by the FDA, and we want our patients to be as informed as possible. The FDA — as well as major physician organizations such as the American Academy of Orthopaedic Surgeons and the American Medical Association — are taking a close look at these regenerative medicine procedures to make sure that they are done in a safe and effective manner.

Currently, no stem cell treatments for arthritis are approved by the FDA. However, clinical trials are under way by some of the leading research hospitals and institutions in the United States. Results are promising.

When will stem cell therapy be FDA approved? It’s important to note that the FDA does not develop or test products. Instead, FDA experts review the results of laboratory, animal and human clinical testing done by manufacturers.

This is part of the reason the Food and Drug Administration is slow to approve drugs and therapies.

Native Stem Cell Centers has been practicing stem cell therapy with since 2014. Our results are proven and effective. Research and experience show us that stem cell therapy is a beneficial treatment for joint pain and arthritis.

FDA approval is not a limiting factor for doctors. Physicians do have the authority to make decisions, such as prescribing drugs for “off-label” use, based on medical expertise and evidence. Dr. Crawford is a board-certified orthopedic surgeon who has been studying arthritis treatments for more than 25 years. His research shows that this is a safe, effective and promising treatment.

Dr. Crawford and the Native Stem Cell Centers staff will address any of your concerns.

FDA Approval Of Stem Cell (BMAC) Injection Therapy

At Native Stem Cell Centers, we perform stem cell injections using stem cells derived from your own bone marrow. These are also known as bone marrow aspirate concentrate injections, or BMAC stem cell therapy.

These treatments fall under the authority of the FDA’s Center for Biologics Evaluation and Research.

The bone marrow extraction and processing we perform satisfies the requirement set forth in the FDA’s 2020 guidelines: Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use.

Our BMAC stem cell therapy procedure satisfies those requirements because the cells taken from bone marrow continue to perform the same basic repair, reconstruction, replacement or supplementation functions when injected into a joint.

While many physicians perform adipose (fat) based stem cell treatments, those treatments do not satisfy the requirements.

FDA Approval Of Platelet Rich Plasma (PRP) Injection Therapy

With regard to PRP injections, there are many elements to consider.

At Native Stem Cell Centers, we use equipment that is approved under the FDA’s 510(k) clearance process for use in preparing PRP.

The FDA approves these devices for use in producing platelet-rich preparations intended to be used to mix with bone graft materials to enhance bone graft handling properties in orthopedic practices.  Other uses are considered “off-label” use of PRP.

Physicians are allowed to use PRP for off-label use if the following guidelines are met.

Physicians have the responsibility to be:

  • well informed about the product,
  • to base its use on firm scientific rationale and on sound medical evidence, and
  • to maintain records of the product’s use and effects.

Native Stem Cell satisfies all these conditions and takes the responsibility of using PRP in new, exciting ways very seriously by making sure that the use is guided by the latest research and regulations.

Patient Safety Matters Most

The FDA’s guidelines and approval process are designed to protect patients from harm and from paying for unnecessary or ineffective treatments.

While we all look forward to a clearer regulatory picture with regard to biologic treatments such as stem cell therapy and PRP injections, it is in everyone’s best interest to be cautious before undergoing these new procedures.

  • Beware of false claims. Many Michigan stem cell clinics make unsupported claims about being FDA approved or even claiming to be doing “stem cell injections” when they are not. They may be doing a PRP injection or injecting an amniotic product that does not contain any live stem cells.
  • Before deciding to have a stem cell or PRP procedure with any provider, it is important to find out exactly what type of injection they will be doing and what type of equipment they are using. In the case of amniotic products, ask what product they use and where that product comes from.
  • Make sure your physician has a clear understanding of the regulatory picture and does not make unsubstantiated claims.

If you have any more questions regarding these topics, please call us to discuss your concerns with our knowledgeable staff.