Interruption of the 1st clinical trial with CSEh: what we can understand


Geron, a Californian company, announced the 14th November that it stopped its clinical trial, on humans, for a treatment using human embryonic stem cell line (GRNOPC1 line). Initiated in October 2010, this trial dedicated to paralyzed patients following to total injuries of spinal cord. On last 20th October, it announced that 4 patients were already treated and that they did not show any complication.
 

A too expensive cost

 

The interruption of this trial, one year after its ultra-mediatized initiation, shows the abandonment, by Geron, of all the researches on human embryonic stem cells (CSEh). Yet the company had focused all its advertisement on this sector, making all its best efforts to obtain the right to start this trial. In its press release, it justifies the interruption of the trial with its too expensive cost. An amazing statement because the company received a 25-million financial support from the Californian Institute for Regenerative Medicine (CIRM) on 5th May 2011. Despite this support, the company does not gain anything with working on CSEh and its losses lead to lay off 38% of its employees. Wanting to resell its activities on stem cells, now it wants to dedicate its resources on two anticancer drugs. The Street, financial news site, depicts Geron situation in a sarcastic way: "the infamous fame of Geron as a serial fund raiser, whose unique success is to let the investors pay for the mistakes, could definitely tarnish the whole field of research on the embryonic stem cells for Wall Street".

 

No efficiency

 

The financial argument is not sufficient for explaining Geron decision: if the phase I trials are for testing the tolerance of the treatment and not its effects, however the company had to wait for a minimum of results. These were absent, which explains the drop of Geron stock market value. In France, Dr Marc Peschanski, director of the I-Stem laboratory, lamented the interruption of this trial giving according to him "a bad signal to investors and government on the state of works on stem cells [...] [whose] potential is still very important". For Pr. Alain Privat, from the Institute of neurosciences of Montpellier, the financial difficulties are only a pretext: "Geron would have easily found additional funds it its treatment showed it was able to improve the patients with affected spinal marrow. I rather think that the treatment has been stopped, due to lack of efficiency, problems of rejections or safety for patients".

 

Research on embryonic stem cells: disillusion?

 

The interruption of Geron trial marks a blow to the research on CSEh: now it seems that this will not lead to miracle treatments as some of its sponsors led to believe. For lack of results, the confidence in CSEh to develop therapies reduces. Regarding the good results of recent researches on adult stem cells, New Scientist announces a change: do adult stem cells "open the way on the clinical level? Absolutely. For instance, around 200 ongoing trials in the world using mesenchymal stem cells [...]. In terms of numbers and commercial potential, they are far ahead".