FDA Warning About Stem Cell Therapies

This is an overview and not meant to replace the FDA warning. Please read the FDA warning resourced below.

The Food and Drug Administration (FDA) regulates stem cell products in the U.S. and recently issued a warning about stem cell therapies that are illegal and even harmful.

Many patients ask about using stem cell therapy, especially those living with sporadic inclusion body myositis (sIBM), an insidious, incurable, disabling muscle disease without any effective treatment options.

The reality is stem cell therapies are not approved for use in sIBM, or in any other form of myositis.

Learn more to protect yourself by visiting the FDA warning below, and watch the video. This provides a great overview of stem cell uses, how clinics promote and advertise illegal and harmful stem cell therapies, and what questions you can ask.

Read the FDA Stem Cell Warning

Canada case highlights possible long-term risks of experimental stem cell therapy

Plain language overview – The idea behind using stem cells is terrific. The problem is in the procedures. You need laboratories that can give you 100.00% purity for the stem cell product. No laboratory in the world is yet there in providing this level of purity. Usually, they use nerve or fat cells from your body as a source. Then, the stem cells are separated out and purified in a laboratory. The stem cells are then manipulated using chemicals to turn them into the type of cell you need to replace.

Here’s an example. If you take nerve cells from inside the olfactory nerve in the nose as your stem cell source, the goal is to make these into nerve stem cells and use them to repair nerve cells, in this case, to repair a spinal cord injury. Here’s the problem. After the laboratory processing, the stem cells are transplanted into the spinal cord. However, if just a few of the original nose nerve cells survive in the transplanted material, over time, these cells will grow. In this example, 12 years after the transplant, the patient developed cancer from the growth of the original nose nerve cells within his spine. This is a common complication that is holding back the wide use of stem cell therapy. Here is the link to the article I’ve used as an example.

Canada case highlights possible long-term risks of experimental stem cell therapy



Myositis Support and Understanding Association (MSU) is a patient-centered, all-volunteer 501(c)(3) nonprofit organization Empowering the Myositis Community. Founded by Myositis patients, for Myositis patients, MSU provides education, support, advocacy, access to research and clinical trial matching, and need-based financial assistance.

View more information: Myositis Support


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