In its attempt to use stem cell technology to treat amyotrophic lateral sclerosis, Neuralstem, Inc. has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for a clinical trial. The company aims to use its patented Human Neural Stem Cell technology for the treatment.
Neuralstem expects to conduct the trial at Emory University with Dr. Johnathan Glass, M.D., Director of the Emory Neuromuscular Laboratory and Director of the Emory ALS Center, as site Principal Investigator (PI). Dr. Eva Feldman, M.D., Ph.D., Head of the A. Alfred Taubman Medical Research Institute and the De Jong Professor of Neurology at the University of Michigan Medical School, will be the overall PI for the ALS trial program. Formal approvals from these institutions to conduct the trial can come only after FDA approval of the trial protocol.
In pre-clinical work, the company’s cells have extended the life of rats with ALS (Lou Gehrig’s disease) as reported the journal TRANSPLANTATION, in collaboration with Johns Hopkins University researchers, and also reversed paralysis in rats with Ischemic Spastic Paraplegia, as reported in NEUROSCIENCE on June 29, 2007, in collaboration with researchers at University of California San Diego.
Neuralstem CEO and President, Richard Garr said,
“Like all first human trials, this proposed trial is primarily designed to test the safety and feasibility of both our stem cells and our method of delivering the cells to the spinal cord in ALS patients.We are also proposing secondary endpoints which we hope will be able to measure a slowing down of the degenerative process.”
Source: Market Watch
Filed under Stem Cell | Comment Below
Genzyme Corp awaits FDA approval for cancer drug December 17th, 2008 Genzyme Corp. is looking for the FDA approval for its cancer drug Mozobil.
Celgene gets FDA approval for human trial of stem cell November 18th, 2008 Biotechnology body Celgene Corp claimed to have received the approval of U.S. health regulators for human testing of stem cell therapy.
CureMichigan Group Backs The Expand Embryonic Stem Cell Research In MichiganJuly 7th, 2008 The Michigan based group called The CureMichigan, is backing a constitutional amendment to expand embryonic stem cell research in the state. The group will launch a campaign to win voter passage of the measure Monday.
Umbilical Cord Blood Bank is a Life SaverJanuary 12th, 2006 The Shanghai Umbilical Cord Blood Bank has completed its pilot period, successfully transfusing six leukemia patients and awaits a license from the Ministry of health. The Ministry of Health has licensed umbilical cord banks in Beijing and Tianjin.
Embryonic Stem Cell trial for spinal cord injury approved by US: For the first time everJanuary 23rd, 2009 Nations first ever human trial on embryonic stem cell research aimed for spinal cord injury patients, which was awaiting for FDA approval, at last get the green signal. This is the beginning of an potentially new chapter, after a long long wait the door of US is now open to adhere the world's future medical wonder, the embryonic stem cell research, which has the potentiality to demolish the killer diseases that make mankind suffered for years.
Researchers want Proposal 2 to restart stem cell research in MichiganOctober 22nd, 2008 After a long ban in embryonic stem cell research, Michigan gets a chance to restart its study with the Proposal 2. Stem cell research is likely to get final approval.
Columbia based stem cell research company gets deal worth $1.25 billionNovember 11th, 2008 It can be a celebration time for the stem cell research firm Osiris Therapeutics. First it posted its profit.
Stem Cell Therapeutics Phase IIb trials for stroke patients achieves FDA approvalMay 14th, 2009 U.S. Food and Drug Administration (FDA) has provided a verbal confirmation to Stem Cell Therapeutics Corp.(SCT) to commence the recruitment of stroke patients under an amended protocol using NTx®-265 for the Company's Phase IIb clinical trial for the acute ischemic stroke treatment. The company is expecting the written approval from FDA in near future.
