Q&A: Bioethicist Leigh Turner on the worrisome boom in unregulated stem cell clinics
By Megan Molteni,
STAT
| 11. 08. 2021
In 2016, the Food and Drug Administration put the emerging stem cell cottage industry on notice. At the time, a few hundred clinics were peddling experimental stem cell therapies costing between $2,000 and $25,000 for conditions ranging from chronic pain to autism to multiple sclerosis without solid scientific evidence that they worked. Federal regulators asserted that the stem cells being sold — usually taken from a patient’s body and slightly processed before being re-injected — were drugs, and therefore required a rigorous approval process.
After contentious public hearings, the agency offered a sort of compromise. For three years, starting in November of 2017, regulators would exercise “enforcement discretion.” In other words, mostly look the other way. The idea was to give the stem cell clinic operators time to convince the agency their products were safe and effective before the crackdown came. The alternative would be to shut down or move abroad.
But according to a new analysis, the period of enforcement discretion led to a boom in the unauthorized stem cell business. “Embedded in that plan was...
Related Articles
By Tomoko Otake, The Japan Times | 04.09.2024
A decade ago, researcher Haruko Obokata caused a sensation when she published two papers in the journal Nature, in which she claimed that she had discovered a way to create stem cells easily using the so-called STAP method.
With STAP...
By Ian Sample, The Guardian | 03.08.2024
Scientists are a step closer to making IVF eggs from patients’ skin cells after adapting the procedure that created Dolly the sheep, the first cloned mammal, more than two decades ago.
The work raises the prospect of older women being...
By Ramon Antonio Vargas, The Guardian | 02.28.2024
Doctors say a man in California who contracted blood cancer while living with HIV is in remission from both potentially fatal illnesses thanks to a treatment they are hailing as remarkable and encouraging.
Paul Edmonds is only the fifth-known person...
By Victoria Gray, Uduak Thomas, and Kevin Davies, The CRISPR Journal | 02.14.2024
In July 2019, medical staff in Nashville dosed the first U.S. patient in the exa-cel therapy trial, sponsored by Vertex Pharmaceuticals and CRISPR Therapeutics. That first patient was Victoria Gray, a mother of four from Forest, Mississippi, a sickle cell...