Subscribe to the BioNews newsletter for free

Login
Advanced Search

Search for
BioNews


Print Page Follow BioNews on Twitter BioNews RSS feed

Like the Progress Educational Trust on Facebook







FDA approves embryonic stem cell therapy for clinical trials

26 January 2009

By Antony Blackburn-Starza

Appeared in BioNews 492

The US Food and Drug Administration (FDA) has allowed the biotech firm, Geron, to begin clinical trials using embryonic stem cell (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 safety first, with further regulatory approval needed to test efficacy.

The trial will involve 8-10 patients being injected with cells derived from human embryos which have been developed into cells called oligodendrocyte progenitor cells (OPCs). It is believed that these cells, when injected into the spines of patients up to two weeks after paralysis, will generate new OPCs. Oligodendrocyte cells create a substance called myelin which covers the shafts of nerve cells in a protective film allowing impulses to travel freely between the brain and body. Injury can cause the oligodendrocyte cells to die and myelin ceases to be produced. The effect is that the nerves then stop functioning correctly leading to paralysis. 'They are the nursemaids of the nervous system', explained Thomas Okarma, chief executive of Geron. 'You cannot get OPCs from the adult body, but now we can make them in large quantities, for the first time, from embryonic stem cells'.

Geron used cell lines eligible for funding under former-President Bush's restrictive policy on ES cell research although it says it did not access federal funding. It took three years for the company to develop the treatment from the laboratory into a product suitable for human testing. It needed to ensure the cells would not continue differentiating creating tumours called teratomas and that the cells would not be rejected by the recipient's immune system, both of which were successfully overcome in animal trials.

The announcement comes as President Obama, who supports ES cell research, takes over the Presidency, although the FDA says it was not politically motivated in approving Geron's work. 'The FDA looks to the science on these types of issues, and we approve [such applications] based on a showing of safety', said Karen Riley, spokeswoman of the FDA, adding that 'political considerations have no role in this process.'

It is reported that Geron, founded in 1992, has spend over $100 million on developing ES cell therapies. Upon news of the announcement of GRNOPC1, the company saw its share price shoot up by over 36 per cent. 'This marks the beginning of what is potentially a new chapter in medical therapeutics - one that reaches beyond pills to a new level of healing: the restoration of organ and tissue function by the injection of healthy replacement cells. The ultimate goal is to achieve restoration of spinal cord function', said Mr Okarma.

 

SOURCES & REFERENCES
The Wall Street Journal | 23 January 2009
 
Stem-cell therapy gives hope to accident victims
The Times | 23 January 2009
 
Therapy that might have helped Christopher Reeve to walk again
The Times | 23 January 2009
 
The Financial Times | 23 January 2009
 

RELATED ARTICLES FROM THE BIONEWS ARCHIVE

22 October 2012 - by Anna Cauldwell 
Two former CEOs of US drug company Geron are bidding to revive its stem cell assets... [Read More]
08 November 2009 - by Dr Jay Stone 
American company Geron Corporation (GC) has been given permission to resume its clinical trials testing the embryonic stem cell treatment GRNPOC1.... [Read More]
28 September 2009 - by Marianne Neary 
The US Food and Drug Administration (FDA) has granted approval to NeuralStem Inc., a Maryland-based biotherapeutics company, to conduct the first human trial using neural stem cells for treatment of amyotrophic lateral sclerosis (ALS). ALS is a type of motor neuron disease often referred to as 'Lou Gehrig's' and 'Maladie de Charcot'. The late-onset condition, of unknown cause, affects approximately two in 100,000 people, including the UK physicist Stephen Hawking and US rock gui... [Read More]
06 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... [Read More]
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.... [Read More]

19 January 2009 - by Ailsa Stevens 
Glasgow-based scientists have announced plans to trial a pioneering stem cell therapy for treating stroke patients later this year. The researchers hope that the therapy, which involves injecting embryonic stem (ES) cells into the brain, may help to reverse the symptoms of stroke, including mobility problems and... [Read More]

HAVE YOUR SAY
Be the first to have your say.

You need to or  to add comments.

By posting a comment you agree to abide by the BioNews terms and conditions

 


 

- click here to enquire about using this story.

Printer Friendly Page

Published by the Progress Educational Trust
PET CONFERENCE
COMMERCIALISATION OF LIFE


Lord Robert Winston, Professor of Science and Society at Imperial College London and speaker at the Progress Educational Trust's conference 'The Commercialisation of Life', taking place in central London on Tuesday 2 December

London, 2 December
Click HERE for details

FREE EVENT
GENOMIC MEDICINE NEEDS YOU


'Genomic Medicine Needs You - Do You Need Genomic Medicine?', a FREE public event being organised by the Progress Educational Trust in central Oxford on the evening of Thursday 16 October 2014

Oxford, 16 October
Click HERE for details

Good Fundraising Code

Become a Friend of PET HERE, and give the Progress Educational Trust a regular donation