ALS stem cell trial begins at U-M Health System with first 2 patients receiving injections

Public release date: 9-Oct-2013 [ | E-mail | Share ]

Contact: Kara Gavin kegavin@umich.edu 734-764-2220 University of Michigan Health System

ANN ARBOR, Mich. Two patients with amyotrophic lateral sclerosis (ALS) have received stem cell injections to their spinal cords at the University of Michigan Health System the first two to receive the experimental injections in Michigan as part of a national clinical trial.

Both research volunteers have returned home and will receive follow-up monitoring and testing to help U-M researchers assess the safety and any potential effect of the injections.

Additional patients with the condition, also known as Lou Gehrig's disease, are being evaluated for possible participation in the trial at U-M and Emory University.

The Phase II trial is approved by the U.S. Food and Drug Administration and funded by Neuralstem, Inc., the Maryland-based company whose stem-cell product the trial is testing. It seeks to study any effect that injected stem cells might have on motor neurons muscle-controlling nerve cells that die in ALS patients, eventually robbing them of the ability to walk, speak and breathe.

Eva L. Feldman, M.D., Ph.D., the Russell N. DeJong professor of neurology at the U-M Medical School and director of the A. Alfred Taubman Medical Research Institute, is the principal investigator for the trial. Feldman serves as an unpaid consultant to the company, and has led the analysis of results from the Phase I trial which concluded in 2012.

In data presented earlier this year, spinal cord injections of up to 100,000 cells were delivered safely and tolerated well in a Phase I trial conducted at Emory. The researchers reported possible signs that in one subgroup of participants, ALS progression may have been interrupted.

"We're going to be permitted to give more injections and more stem cells, in Phase 2," said Feldman. "We're very excited that we have been able to bring this important work to the University of Michigan."

Parag Patil, M.D., Ph.D., a U-M neurosurgeon and biomedical engineer, performed both operations on the U-M trial participants. In each case, the patient's spinal column was unroofed and the spinal cord exposed to receive the cells. The cells are introduced via a custom-designed delivery device that is affixed to the subject's spinal bones so that it moves with the patient's breathing throughout the process.

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ALS stem cell trial begins at U-M Health System with first 2 patients receiving injections