Skip to main content
Premium Trial:

Request an Annual Quote

Decision on Stem Cell Therapeutic

The US District Court of Appeals for the DC Circuit ruled this week that the Food and Drug Administration can regulate stem cells as drugs, reports Regulatory Focus. The ruling upholds a lower court decision from 2012.

The case stems from FDA's 2008 warning letter to Regenerative Sciences, in which the agency contended that the company was in violation of federal regulations. Regenerative Sciences was using patients' mesenchymal stem cells as part of its Regenexx procedure to treat arthritis and related injuries, The Scientist notes.

According to Regulatory Focus, FDA argued that the company, now known as Regenexx, did more than "minimal manipulation" to the cells and thus the product had to be regulated as a drug. The company, meanwhile, said that FDA could regulate drugs but not the practice of medicine, which includes procedures like Regenexx.

The circuit court judge, though, sided with FDA. The process "alters the MSCs' relevant biological characteristics and is therefore more than minimal manipulation," Judge Thomas Griffith says in his decision.

Regulatory Focus notes that Regenexx does not plan to appeal the decision to the Supreme Court.

The Scan

RNA Editing in Octopuses Seems to Help Acclimation to Shifts in Water Temperature

A paper in Cell reports that octopuses use RNA editing to help them adjust to different water temperatures.

Topical Compound to Block EGFR Inhibitors May Ease Skin Toxicities, Study Finds

A topical treatment described in Science Translational Medicine may limit skin toxicities seen with EGFR inhibitor therapy.

Dozen Genetic Loci Linked to Preeclampsia Risk in New GWAS

An analysis of genome-wide association study data in JAMA Cardiology finds genetic loci linked to preeclampsia that have ties to blood pressure.

Cancer Survival Linked to Mutational Burden in Pan-Cancer Analysis

A pan-cancer paper appearing in JCO Precision Oncology suggests tumor mutation patterns provide clues for predicting cancer survival that are independent of other prognostic factors.