What Stem Cell Treatments Are FDA-Approved?
The following quote was excerpted from an article posted on the Food and Drug Administration (FDA) website in Sept. 2019:
The only stem cell-based products that are FDA-approved for use in the United States consist of blood-forming stem cells (hematopoietic progenitor cells) derived from cord blood. These products are approved for limited use in patients with disorders that affect the body system that is involved in the production of blood (called the “hematopoietic” system). These FDA-approved stem cell products are listed on the FDA website. Bone marrow also is used for these treatments but is generally not regulated by the FDA for this use.
Source: FDA Warns About Stem Cell Therapies (Sept. 2019)
Hematopoietic stem cells are immature cells that can develop into all types of blood cells, including white and red blood cells, and platelets. Hematopoietic stem cells are found in peripheral blood (blood circulating throughout the body) and bone marrow.
It should be noted that while the FDA has officially only approved one stem cell treatment, more than 13,000 patients have received this type of therapy and had their results published and indexed in the U.S. Library of Medicine.
Why have so many procedures been performed despite just one treatment approval? The FDA provides almost no regulatory oversight of orthopedic procedures using bone-marrow extracts or platelets because they’re considered low risk.
While the FDA has the authority to regulate stem cell treatments, it adopted an industry-friendly approach in 2017 by giving organizations a three-year grace period in which to describe their products or treatments so the agency could determine whether they meet the criteria of drugs that would require agency approval. Thus far, few companies have submitted any stem cell treatment information.
The “compliance and enforcement discretion policy for certain human cell, tissue, and cellular tissue-based products” The New York Times refers to ended May 31, 2021.
This post will be enhanced with more research as it becomes available.
Comments and suggestions are welcome.
