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Spinal stem cell treatment gets go ahead from the FDA

8 November 2009
Appeared in BioNews 533

American company Geron Corporation (GC) has been given permission to resume its clinical trials testing the embryonic stem cell treatment GRNPOC1.

GC had originally been given permission to begin the trials in January 2009, but was then told to wait after a round of preclinical animal tests showed some worrying side effects. Researchers found that the animals given the GRNOPC1 treatment developed a higher number of cysts at the area of spinal cord injury than had been seen in previous studies. There were concerns that these cysts could produce cancerous teratomas, a detrimental side effect that could also potentially affect patients. This finding caused GC share prices to fall by 14 per cent after the trial suspension was announced. However further investigation has shown these cysts to be benign, confined to the site injury and not associated with any serious adverse effects, and so now the FDA has agreed to allow the human trials to begin.

GRNOPC1 consists of oligodendrocyte progenitor cells (OPCs), a type of neural cell derived from a human embryonic stem cell line (hESC). OPCs have the potential to differentiate into mature oligodendrocytes, which are a type of neuroglia cell responsible for coating nerve fibres with the insulating substance myelin. Loss of myelin after spinal cord injury can contribute to the loss of neural function. Just one oligodendroctye can help to insulate 50 nerve fibres, so GC aim to test if injections of these progenitor cells can improve recovery in people with spinal cord injuries.
Geron Corporation's Stem Cell Trial |  2 November 2009
23 August 2010 - by Kyrillos Georgiadis 
Japanese researchers have overcome a major obstacle to treating severe spinal cord injuries using stem cells taken from the brain...
2 August 2010 - by Dr Marianne Kennedy 
Biotechnology company Geron has been given the all clear for the world's first clinical trial involving human embryonic stem cells (hESCs). This comes a year after the US Food and Drug Administration (FDA) placed the study on hold amid safety fears...
23 November 2009 - by Alison Cranage 
Stem cell therapy came one step closer to being tested for the first time in people this week, as a US company applied to the Food and Drug Administration (FDA) for a licence to start a clinical trial. The embryonic stem (ES) cell therapy is being developed to treat Stargardt, a currently incurable disease that causes blindness in young people....
6 September 2009 - by Nishat Hyder 
Information has come to light regarding the US Food and Drug Adminstration (FDA)'s freeze on the clinical trails of GRNOPC1, a groundbreaking therapy for spinal cord injury derived from human embryonic stem cells (ES cells) being undertaken by biotech company Geron...
23 August 2009 - by Alison Cranage 
The US Food and Drug Administration (FDA) has delayed the start of a clinical trial that plans to use human embryonic stem cell(ES) cells to treat spinal cord injury. The trial is being run by Californian based company Geron. The FDA originally gave the go-ahead for the trial in January, but now has halted the start in order to review new data submitted by Geron....
26 January 2009 - by Antony Starza-Allen 
The US Food and Drug Administration (FDA) has allowed the biotech firm, Geron, to begin clinical trials using embryonic stem (ES) cells to help treat spinal cord injury sufferers who have become paralysed from the chest down. The product known as GRNOPC1 will be tested for its...
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