Stem cell transplantation study for the treatment of ALS – Phase 2
The phase 2 trial focused on the safety and maximum tolerated dose of Human Spinal Cord Derived Neural Stem Cell Transplantation. This study expanded on the work of the phase 1 study directed by Eva L. Feldman, M.D., Ph.D., who is the principal investigator and director of the first-ever FDA-approved human clinical trial of stem cells injected directly into the spinal cords of ALS patients.
Phase 1 of the trial, designed to study the safety of the procedure, was completed in 2013 with no significant adverse side effects to patients. And follow-up patient evaluations have produced some extraordinary data: Several participants in the trial, who were treated early in their disease, were determined to have had little or no significant progression of ALS for more than 700 days post-surgery.
Updated July 2015: Fifteen patients were studied in the phase 2 study, the last 3 of which received 8 million stem cells injected into the lumbar spinal cord followed by 8 million stem cells injected into the cervical spinal cord.
All procedures have been completed and the trial is still ongoing. No data has been released.
Updated May 2016: The next phase of the stem cell study has not started and is not recruiting participants. We do not have an anticipated start date at this time. An online central registration will be used to select participants. Your local treating neurologist will be required to submit documentation to this registry where it will be reviewed by an independent physician to determine study eligibility. Therefore, clinical consultation at University of Michigan is not required to be considered for the trial. We encourage you to periodically check the Neuralstem website at www.neuralstem.com, for updates on the study status. You can also contact Neuralstem directly for more information.
We also do not know the entry criteria at this time, but anticipate it will be similar to the Phase 2 study which included age less than 70, ability to stand and walk without another person’s assistance, forced vital capacity (FVC) greater than 60%, antigravity movement in arms, and disease duration less than 3 years, among others.