Unproven Stem Cell Ruling Creates Uncertainty

Earlier this month, a US judge ruled that a facility offering unproven stem cell therapy treatments did not fall under the FDA’s regulatory jurisdiction and, therefore, cannot be blocked by the agency. The FDA had initiated a lawsuit against the California Stem Cell Treatment Center in 2018 – arguing that stem cell procedures were subject to the agency’s regulation. The court rejected this, saying, “The adipose tissue Defendants remove from patients clearly consists of human cells. And whatever is injected back into patients as part of Defendants’ SVF Surgical Procedure and Expanded MSC Surgical Procedure certainly contains such cells.”

Previous articles published on The Medicine Maker website have discussed the dangers of unapproved cell therapies, including Putting a Stop to Cell Therapy “Snake Oil” and The Cell Therapy Guardians.

The International Society for Cell & Gene Therapy (ISCT) has issued a statement expressing its concern – and has raised several scientific inaccuracies in the ruling. The statement says, “The ruling made statements concerning stromal vascular fraction (SVF) that are both inaccurate and unsupported by current scientific knowledge. The ruling mistakenly claims the production of SVF is essentially equivalent to surgery and mischaracterizes SVF as a naturally occurring, circulating, unaltered biological entity that is simply relocated from adipose tissue to other diseased parts of the body by surgical means.”

The ruling also asserted that the clinical networks use FDA-authorized devices to produce autologous stem cell treatments. However, it “does not take into account that the devices in question may not have been authorized by the FDA, or authorized for other purposes, and have not been designed for the production of stem cell therapies.”

The ISCT also argues that the ruling’s claim that culture-expanded mesenchymal stem cells should not be regulated as drugs conflicts with scientific evidence – and opens the door to potentially dangerous unchecked therapies.

ISCT president Jacques Galipeau, said, “This ruling introduces regulatory uncertainty into the CGT market, and unscrupulous clinics prey on this uncertainty to market unproven interventions to patients. The ruling reinforces the imperative market need for informative resources that establish scientific consensus, standards, and best practices. ISCT will continue to work with FDA and other like-minded national and international organizations and regulatory agencies to achieve ISCT’s mission to drive clinical translation of cell and gene therapies worldwide.”