Stem Cell Trial ALS Clinic

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.

https://clinicaltrials.gov/show/NCT01730716

Future trials

Updated July 2015: No details are avakilable for a possible next pahse of the study at this time and we are not enrolling patients. We encourage any interested persons to continue to monitor the Neuralstem website for additional details as they are released.

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Stem Cell Trial ALS Clinic