FDA approves phase 2 of stem cell trial for ALS.
ANN ARBOR, Mich., April 17, 2013 -- The FDA has approved the University of Michigan as the second site in a clinical trial of stem cell injections in patients with the deadly degenerative disease known as amyotrophic lateral sclerosis, often called ALS or Lou Gehrig's disease.
The first phase of the trial has taken place at Emory University, with Eva Feldman, M.D., Ph.D., of UM serving as principal investigator.
The FDA approval of a Phase 2 trial was announced by Neuralstem, the company whose product the trial is testing. The Phase 2 trial will continue lo evaluate the safety of the stem cell injections, delivered directly into patients' spinal cords in escalating doses of up to 400,000 cells per injection, with a maximum of 40 injections. It will also assess any signs that the injections might be impacting patients' ALS symptoms or progression.
Feldman serves as an unpaid consultant to the company, and has led the analysis of results from the Phase 1 trial. In data presented last year, spinal cord injections of up to 100,000 cells were delivered safely and tolerated well, with possible signs that in one subgroup of participants, ALS progression may have been interrupted.
"In Phase 2, we'll be injecting stem cells into the upper part of the spinal cord, and our goal is to continue to assess whether this approach is safe, and to look at whether this approach offers some benefit to our patients. We are very pleased at the potential to bring this trial to the University of Michigan, where the initial research behind this technology was done - as well as having it continue at Emory," said Feldman, a professor of neurology at the U-M Medical School.
The approach uses injections of stem cells delivered during an operation performed by a neurosurgeon. The first phase of the trial involved 15 patients; specific plans for Phase 2 are still being made.
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|Title Annotation:||In The Clinic ...|
|Publication:||Stem Cell Research News|
|Date:||Apr 29, 2013|
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