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US court ruling frees regulator to police stem cell therapies

30 July 2012
Appeared in BioNews 667

A US federal court has ruled that a stem cell product is classified as a 'drug', falling under the jurisdiction of the Food and Drug Administration (FDA). The ruling allows the FDA to regulate stem cell therapy in the USA and could open clinics that offer stem cell treatments to federal liability.

The FDA took legal action against Regenerative Sciences, a clinic based in Broomfield, Colorado, in 2010 over its treatments involving mesenchymal stem cells. It sought an injunction to prevent the clinic from offering what it said were unapproved treatments that were not shown to be effective in clinical studies. The FDA also claimed that the facilities at Regenerative Sciences did not meet its standards.

The clinic challenged the FDA's jurisdiction to regulate its orthopaedic treatment, Regenexx, on the grounds that the procedure used patients' own stem cells, which were harvested, manipulated, and injected back into the same patient. The company argued as the cells were not significantly modified during the procedure it should be categorised as a routine treatment and therefore not subject to federal regulation by the FDA.

Although Regenerative Sciences agreed to stop offering Regenexx during the proceedings, US District Judge Rosemary Collyer, who gave judgment in favour of the FDA, said there remained a 'cognisable danger of recurrent violation'.

'It is a close question but ultimately the court concludes that the Regenexx Procedure is subject to FDA enforcement because it constitutes a "drug" and because a drug that has been shipped in interstate commerce is used in the solution through which the cultured stem cells are administered to patients', said Judge Collyer in granting the permanent injunction against Regenerative Sciences. The court ruling now means that any cells that undergo more than 'minimal manipulation' are subject to federal regulations.

Commenting on the ruling, Dr Christopher Centeno, medical director of Regenerative Sciences said: 'This is really round one. Our position remains that a patient's cells are not drugs'. He told Nature News that he intends to appeal the decision.

Christopher Scott, of the Center for Biomedical Ethics at Stanford University, California welcomed the decision, however. 'I think it's a good ruling, and I'm glad to see that that the FDA has exercised its muscle on the case', he said.

A statement on the Regenexx webpage reads: 'This battle is largely about who has the right to regulate an individual's body. The FDA took the position that the cells in your body, under certain circumstances, are prescription drugs. The physician practice behind the Regenexx procedures has challenged in court this ''Your cells = drugs'' policy'.

Many medical professionals, including Scott, want the FDA to step in and regulate stem cell therapies, especially since their effectiveness is as yet unproven. On the other hand, some commentators fear FDA control will limit stem cell therapies so that people will seek riskier treatment elsewhere.

Court ruling: FDA can regulate stem cell clinics
Nature News Blog |  26 July 2012
Home Page
Regenexx |  24 May 2022
Judge Halts Regenexx Stem Cell Treatments
Courthouse News Service |  26 July 2012
Ruling frees FDA to crack down on stem cell clinics
New Scientist |  25 July 2012
USA v Regenerative Sciences, LLC, Order of Permanent Injunction
Scribd |  23 July 2012
19 September 2016 - by Dr Lucy Freem 
The US Food and Drug Administration has held a public hearing on proposals to regulate stem cell treatments in the same way as drugs...
4 July 2016 - by James Brooks 
The authors of a study detailing the rapid expansion of unlicensed stem-cell therapies in the US have called on the FDA to act to stop thousands of patients being used as 'unwitting guinea pigs' for untested treatments...
21 September 2015 - by Paul Waldron 
The Food and Drug Administration must do more to control clinics offering unproven stem cell treatments in the USA, say scientists....
7 January 2013 - by Dr Linda Wijlaars 
Bone fragments were removed from the eyelid of a woman after a facelift that used her own stem cells yielded some unexpected results...
12 November 2012 - by Dr Daniel Grimes 
A biotechnology company has come under fire after reporting success of its 'life-saving' stem cell based therapies ahead of a major stock sale, which occurred before investors became aware of news that a patient who had received its treatment had died....
6 February 2012 - by Dr Maria Botcharova 
A clinic in California has announced that its doctors are licensed and trained to carry out a stem cell treatment for chronic pain. Meanwhile, the US Food and Drug Administration (FDA) is pursuing a lawsuit against Regenerative Sciences, the company that developed the technique...
23 August 2010 - by Nishat Hyder 
The US Food and Drug Administration (FDA) has demanded a federal injunction from the US District Court of the District of Columbia to stop Regenerative Sciences (a Colorado based stem cell clinic) from using patients' own stem cells as medicinal treatment...
8 March 2010 - by Harriet Vickers 
A US company has been granted beneficial 'orphan drug' status by the American Food and Drug Administration (FDA) for an embryonic stem cell therapy it's developing to treat a rare form of blindness...
10 January 2010 - by Dr Vivienne Raper 
Scientist and patient groups want more safeguards to prevent clinics in the UK from offering unproven stem cell treatments, according to the Guardian newspaper. The calls come as a Harley Street doctor - Robert Trossel - comes before the General Medical Council (GMC) accused of misconduct, the newspaper reports. According to the Guardian, the upcoming GMC hearing will consider allegations that he offered, and made false claims about, stem cell therapy. Dr Trossel is accused of ...
US court ruling frees regulator to police stem cell therapies ( - 13/11/2012)
Personally everyone wants to get resolve from the problems , making legal about stem cell to a limitation will be fine . but its not that easy to maintain once the permission is given so i feel as per medical usage its should be permit not for other purposes
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