drugset / Trial / NCT03280056
Safety and Efficacy of Repeated Administrations of NurOwn® in ALS Patients
Phase 3
Completed
196 enrolled
Brainstorm-Cell Therapeutics
California Institute for Regenerative Medicine (CIRM) · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study will evaluate the safety and efficacy of repeated administration of NurOwn® (MSC-NTF cells) therapy, which is based on transplantation of autologous bone marrow derived mesenchymal stromal cells (MSC), which are enriched from the patient's own bone marrow, propagated ex vivo and induced to secrete Neurotrophic factors (NTFs). The autologous NurOwn® (MSC-NTF cells) are back-transplanted into the patient intrathecally by standard lumbar puncture where neurons and glial cells are expected to take up the neurotrophic factors secreted by the transplanted cells
Timeline
- Start
- 2017-08-28
- Primary completion
- 2020-09-29
- Completion
- 2020-09-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | NurOwn | Cell therapy | 1e+08 cells | Intrathecal |
| Comparator | NurOwn | Cell therapy | 1.25e+08 cells | Intrathecal |