ReNeuron has been … finally … given full regulatory approval by the UK Gene Therapy Advisory Committee to initiate a stem cell trial for ischemic stroke after a 5 years approval cycle.
RENE.L also has new preclinical data backing the efficacy of its lead CTX stem cell line for peripheral arterial disease.
- The stem cells have generated “significant recovery of blood flow” in the ischemic limb. This CTX cell line has been extremely well-characterized and scaled up and extensively tested as part of their ReN001 program. Hopefully, this cell line will be able to further the clinic trial as a non-patient-specific therapeutic candidate for peripheral arterial disease,
- In this Glasgow based trial, 12 stroke victims in groups of 3 groups and treated with fetal stem cells for 6 to 24 months following a stroke,
- Doses will begin at around 2 M brain cells and grow to 20 M,
- The stem cells being tested have been extracted from the fetuses of aborted babies has sparked controversy in the UK,
- Repeated attempts to get the US FDA to approve a Phase I trial have dragged on for many months (almost a year) with the US FDA still seeking more information on their ReN001 candidate.
“If it (stem cell therapy) works, as it has done in animal model systems, it (this therapy) may allow new nerve cells to grow or regeneration existing cells with actual recovery of function in patients who would not otherwise be able to regain function.” (BBC News)
ReNeuron is a UK-based stem cell company. Their primary objective is the development of stem cell therapies targeting areas of significant unmet or poorly met medical need. RENE.L’s shares are traded on the London AIM market.
- Reiterating, RENE.L should be watched for future news and platform development within this sector/ industry,
- RENE.L since our last post on 1/29/09 , is trading down at £7.05 (52 week range of £3.50 to £11.35) with a market cap of £23.17 M.