FDA2018-09-28T03:54:56+00:00

FDA

Patients frequently ask if stem cell therapy is approved by the FDA and we want our patients to be as informed as possible when making their decision to have a stem cell or PRP procedure.  The FDA, as well as major physician organizations such as the AAOS and the AMA, are taking a close look at these procedures to make sure that they are done in a safe and effective manner.

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, what type of equipment they are using and in the case of amniotic products, what product they use and where that product comes from.  Many clinics and physicians make false or unsupported claims about being FDA approved or even claiming to be doing “stem cell injections” when they are, in fact, only doing a PRP injection or injecting an amniotic product that does not contain any live stem cells.

Stem Cell (BMAC) Injection Therapy

At Native Stem Cell, we perform stem cell injections using stem cells derived from bone marrow or bone marrow aspirate concentrate (BMAC) injections.  These injections fall under the authority of the FDA’s Center for Biologics Evaluation and Research (CBRE.)  In September of 2016 the FDA held hearings on the use of stem cells in which certain guidelines were discussed and later finalized in December of 2017 in the FDA document Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use.

In this guidance, the FDA defines how stem cells can be used and what type of stem cells can be used.  Any cellular or tissue-based therapy must meet the requirements of being minimally manipulated and used only for homologous use.

Minimal manipulation means the cells or tissue must be processed in a way that “does not alter the original relevant characteristics of the tissue relating to the tissue’s utility for reconstruction, repair, or replacement,” and “does not alter the relevant biological characteristics of cells or tissues.”  The bone marrow extraction and processing we perform satisfies the minimal manipulation requirement.

Homologous use is defined as “the repair, reconstruction, replacement, or supplementation of a recipient’s cells or tissues with an HCT/P that performs the same basic function or functions in the recipient as in the donor (21 CFR 1271.3(c)), including when such cells or tissues are for autologous use.”  So what does this mean?  To put it simply, the transferred cells or tissue must still operate as intended when they are moved from one location to another, even within a patient’s own body.  Again, the procedure we perform satisfies this requirement because the cells harvested from bone marrow continue to perform the same basic repair, reconstruction, replacement, or supplementation functions when injected into a joint.

Importantly, while many physicians are performing adipose (fat) based stem cell treatments, these treatments do not satisfy either of the requirements above and these physicians are technically in violation of the FDA’s guidance.

To read the FDA document click here

Platelet Rich Plasma (PRP) Injection Therapy

With regards to PRP injections, again, there are many elements to consider.  First, there are centrifuge machines and PRP kits and equipment that are FDA approved.  At Native Stem Cell, we use equipment that is approved under the FDA’s 510(k) clearance process for use in preparing PRP.  However, 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.  Anyone, including Native Stem Cell, who is injecting PRP into a joint, tendon or ligament, is doing so in an off-label fashion.

The FDA’s Center for Biologics Evaluation and Research provides guidance on this use as well though.  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 of 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.

For more information on PRP regulations click here

It is important to remember that 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 regards to biologic treatments such as stem cell and PRP injections, it is in everyone’s best interest to be cautious before undergoing these new procedures.  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 to discuss with our knowledgeable staff.