drugset / Trial / NCT01777646
Autologous Mesenchymal Bone Marrow Stromal Cells Secreting Neurotrophic Factors (MSC-NTF), in Patients With Amyotrophic Lateral Sclerosis (ALS)
NaSingle-groupOpen-labelTreatment
Summary
The study will evaluate the safety, tolerability and therapeutic effects of transplantation of escalating doses of autologous cultured mesenchymal bone marrow stromal cells secreting neurotrophic factors (MSC-NTF), in patients with amyotrophic lateral sclerosis (ALS).
Timeline
- Start
- 2012-12
- Primary completion
- 2014-09
- Completion
- 2015-09
Outcome
Met primary endpoint
release “We met our primary endpoint and demonstrated that a single dose of NurOwn was safe and well-tolerated” brainstorm-cell.com ↗
Publications
- Gothelf Y, Kaspi H, Abramov N, Aricha R. miRNA profiling of NurOwn(R): mesenchymal stem cells secreting neurotrophic factors. Stem Cell Res Ther. 2017 Nov 7;8(1):249. doi: 10.1186/s13287-017-0692-1.
- Petrou P, Gothelf Y, Argov Z, Gotkine M, Levy YS, Kassis I, Vaknin-Dembinsky A, Ben-Hur T, Offen D, Abramsky O, Melamed E, Karussis D. Safety and Clinical Effects of Mesenchymal Stem Cells Secreting Neurotrophic Factor Transplantation in Patients With Amyotrophic Lateral Sclerosis: Results of Phase 1/2 and 2a Clinical Trials. JAMA Neurol. 2016 Mar;73(3):337-44. doi: 10.1001/jamaneurol.2015.4321.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MSC-NTF | Cell therapy | 9.4e+07 cells | Intramuscular |
| Subject | MSC-NTF | Cell therapy | 1.41e+08 cells | Intramuscular |
| Subject | MSC-NTF | Cell therapy | 1.88e+08 cells | Intramuscular |