Stem cell laws and regulations: FDA regulation of stem cell therapies

If you wanted to upgrade the old film, “The Graduate,” you’d have Dustin Hoffman’s character shouting out “stem cells!” instead of “plastics!” Of course, he would immediate meet his favorite regulatory attorney to understand FDA regulation of stem cell therapies. In Beyond Complementary Medicine: Legal and Ethical Perspectives (University of Michigan Press), I wrote a chapter called, “Do Clones Have Souls? And Other Medico-Legal Mysteries.”

Reproductive cloning, by the way, is illegal in the U.S. You can’t clone your favorite dog or cat (or cousin).

Therapeutic cloning is another story.

A Bit About Stem Cells

Embryonic stem cells are cultured from embroyblasts after fertilization, quite often from donated embryos from IVF clinics. The embryo is destroyed after.

Some countries ban or restrict the use of embryonic stem cells. In the U.S., some states allow and other states disallow the use of embryonic stem cells for research. In California, stem cell research is funded via Prop 71, which created the California Institute for Regenerative Medicine.

There are different kinds of stem cells, such as pluripotent and mesechymal. Pluripotent stem cells can crate any fetal or adult cell type; among the places where these can be found is umbilical cord blood.

NIH maintains a webpage on Stem Cell Information, including a primer on stem cell basics. NIH explains: “When a stem cell divides, each new cell has the potential either to remain a stem cell or become another type of cell with a more specialized function, such as a muscle cell, a red blood cell, or a brain cell.” This makes stem cells the frontier for regenerative or reparative (or “cell-based”) medicine. For example, grow an organ from stem cells instead of getting one donated; or, direct the stem cells to replace cells and tissues and “to treat diseases including Alzheimer’s diseases, spinal cord injury, stroke, burns, heart disease, diabetes, osteoarthritis, and rheumatoid arthritis.”

What makes stem cells so fascinating is that they can possess the property of self-renewal (i.e., they can go through many cycles of cell division while still maintaining their undifferentiated state), and multipotency (the ability to generate several distinct cell types). As NIH states: “All stem cells—regardless of their source—have three general properties: they are capable of dividing and renewing themselves for long periods; they are unspecialized; and they can give rise to specialized cell types.”

FDA Regulation of Stem Cells

FDA, while upbeat about the potential promise of stem cells, warns consumers about stem cell claims. FDA expresses concern about consumers being misled by stem cell claims (as by claims about other therapies).

FDA gives similar warnings to those it gives for other healthcare products: it cautions consumers to make sure that any stem cell treatment they are considering has been approved by FDA or is being studied under a clinical investigation that has been submitted to and allowed to proceed by FDA. FDA has approved only one stem cell product… FDA regulates stem cells in the U.S. to ensure that they are safe and effective for their intended use…. Consumers need to be aware that at present—other than cord blood for certain specified indications—there are no approved stem cell products.

FDA advises consumers to ask their physician if the necessary FDA approval has been obtained or if the patient will be part of an FDA-regulated, clinical study, even if stem cells are the patient’s own.

Remember that FDA has the power to bring criminal charges related to manufacturing, selling and using stem cells without FDA sanction or approval. FDA reports one case in which FDA ‘thwarted’ a “stem cell scheme:”

According to the criminal indictment, one of the accused, a licensed midwife who operated a maternity care clinic in Texas, obtained umbilical cord blood from birth mothers, telling them it was for “research” purposes. Instead, the midwife sold the cord blood to a laboratory in Arizona which, in turn, sent the blood to a paid consultant at a university in South Carolina. The owner of the laboratory in Arizona was convicted in August 2011 of unlawfully introducing stem cells into interstate commerce. She faces up to 3 years in prison and a fine of up to $10,000.

The consultant, an assistant professor, used university facilities to manufacture stem cell products. He then sent the products back to the lab, which sold them to a man representing himself as a physician licensed in the U.S. The man then traveled to Mexico to perform unapproved stem cell procedures on people suffering from cancer, multiple sclerosis and other autoimmune diseases.

The three defendants allegedly received more than $1.5 million from patients seeking treatment for incurable diseases.

In January 2014, a Texas man was sentenced for a conspiracy to introduce misbranded and unapproved new drugs into interstate commerce. Defendant “falsely represented to the public that he had extensive training and experience regarding stem cells and stem cell therapy, when his exposure was actually limited to attending seminars and reading materials published by researchers,” and treated a patient for neurological symptoms, with stem cells. He also represented that his treatment protocol was FDA-approved and was effective for treatment of ALS, MS and Parkinson’s.

In its Consumer Information on Stem Cells, FDA states that it has “not approved any stem cell-based products for use, other than cord blood-derived hematopoietic progenitor cells (blood forming stem cells) for certain indications including certain blood cancers and some inherited metabolic and immune system disorders.”

FDA points out safety concerns with stem cell treatments, including development of tumors. FDA regulates stems cells through its Center for Biologics Evaluation and Research (CBER), not its drug approval center.

FDA jurisdiction over stem cell therapies has recently been challenged – but as Bob Marley put it, “I fought the law, and the law won.” More about that – and about state law regulation of stem cell therapies – in subsequent articles. If you are introducing stem cell therapies to market, or, a physician delivering stem cell therapies in practice, contact healthcare legal counsel about relevant laws and regulations.

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