FDA on Wednesday sent warning letters to at least 20 companies the agency believes are offering unapproved stem cell treatments and products to consumers.

Stem cell therapies—and 7 other innovations that could transform health care

A regulatory gray area

Stem cells are considered a promising avenue for medical research, as the cells can develop into nearly any type of cell, meaning they could potentially replace or repair a wide range of dysfunctional cells. However, few stem cell treatments have been validated by clinical trials, and some proposed treatments have turned out to be harmful.

In recent years, hundreds of clinics have started selling stem cell products that the companies claim can treat a range of ailments, but FDA has approved only a handful of stem cell treatments, meaning most of the clinics are performing unapproved procedures.

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FDA in December 2018 sent 45 warning letters to manufacturers of stem-cell-related products, and last May the agency filed lawsuits against US Stem Cell Clinic of Sunrise, Florida and California Stem Cell Treatment Center to stop the clinics from marketing unapproved stem-cell treatments, the Wall Street Journal reports.

The agency has said it is striving to strike a balance between supporting innovation and protecting patient safety. Former FDA Commissioner Scott Gottlieb and Peter Marks, director of FDA's center on biologic therapies, in a statement said, "Most forms of regenerative medicine are still in early stages of development, and adult stem cells and stem cells from birthing tissues have not been shown to be safe and effective for use."

FDA cracks down on stem cell products

FDA in the latest round of warning letters said the organizations may be selling unapproved stem-cell products that supposedly treat a range of medical conditions, the Journal reports. The letters, which were mostly sent to medical providers and manufacturers, ask the companies whether their stem-cell products were approved by FDA.

One of the warning letters was issued to Cord for Life, a Florida-based stem cell company that uses human umbilical-cord blood cells as treatments. FDA in its warning letter to Cord for Life said the company's "unvalidated manufacturing processes" and "inadequate personnel aseptic practices" pose "a significant risk that your products may be contaminated with microorganisms or have other serious product quality defects."

Donald Hudspeth, operations manager for Cord for Life, told the Washington Post that the company has already taken action to address the safety issues raise in the letter (Burton, Wall Street Journal, 4/3; Wan/McGinley, Washington Post, 4/4).

Stem cell therapies—and 7 other innovations that could transform health care

Our new report explores the clinical technology pipeline to help health care leaders become more conversant in the major vectors of innovation, leading applications of new technologies, and the business implications for established providers. Read on to unpack the new innovation agenda.

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