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Also known as NurOwn (MSC-NTF cells), NurOwn® (MSC-NTF cells)
NurOwn · 2 trials · 2 indications
The ALSFRS-R is a quickly administered (10 minutes) ordinal, validated rating scale (ratings 0-4) used to determine participants' assessment of their capability and independence in 12 functional activities. All 12 activities are relevant in ALS. Initial validity was established by documenting that in ALS patients, change in ALSFRS-R scores correlated with change in strength over time, as measured by quantitative neuromuscular strength testing, and with quality of life measures, and predicted survival. The total score of ALSFRS-R ranges from 0-48, with higher score being better.
Combined safety of all 3 intrathecal doses of NurOwn® (MSC-NTF cells) Number of participants who experienced Treatment-emergent Adverse Events during the study. Treatment-emergent Adverse Event is an adverse event that occurs for the first time after initiation of first treatment or if it had occurred prior to initiation first treatment, it worsens in severity after initiation of first treatment.
| Arm | Type | Description |
|---|---|---|
| NurOwn® (MSC-NTF cells) | ACTIVE_COMPARATOR | Three Intrathecal administrations of NurOwn® (MSC-NTF cells) at bi-monthly intervals |
| Placebo | PLACEBO_COMPARATOR | Three Intrathecal administrations of Placebo at bi-monthly intervals |
| NurOwn (MSC-NTF cells) | EXPERIMENTAL | Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors |
| Name | Type | Description |
|---|---|---|
| NurOwn® (MSC-NTF cells) | BIOLOGICAL | NurOwn® (MSC-NTF): One course of treatment that includes three separate intrathecal injections of 100-125 x 10\^6 cells every 8 weeks NurOwn® (MSC-NTF): Autologous, bone marrow-derived, mesenchymal stem cells secreting neurotrophic factors |
| Placebo | OTHER | One course of treatment that includes three separate intrathecal injections of Placebo every 8 weeks Placebo: liquid solution in syringe for injection |
| Bone Marrow aspiration | OTHER | Bone Marrow aspiration |
| NurOwn (MSC-NTF cells) | BIOLOGICAL | Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors |
Inclusion Criteria: * ALS diagnosed as possible, laboratory-supported probable, probable, or definite as defined by revised El Escorial criteria. * Having onset of ALS disease symptoms, including limb weakness within 24 months at the Screening Visit. * ALSFRS-R ≥ 25 at the screening Visit. * Uprigh...
NurOwn is being developed for amyotrophic lateral sclerosis (ALS) and for chronic progressive multiple sclerosis. It is an investigational cell-based therapy and has not been approved for commercial use. Brainstorm Cell Therapeutics is studying it in patients with these neurological conditions.
NurOwn is developed by Brainstorm Cell Therapeutics Inc., a biotechnology company whose shares trade under the ticker BCLI. The company sponsors the clinical program for the therapy in ALS and progressive multiple sclerosis.
NurOwn has completed a Phase 3 trial in ALS and a Phase 2 trial in chronic progressive multiple sclerosis. It remains an investigational therapy and is not approved for marketing. No active trials are currently listed for NurOwn.
NurOwn has been studied in two completed trials. NCT03280056 was a Phase 3 trial in ALS with 196 participants. NCT03799718 was a Phase 2 trial in progressive multiple sclerosis with 23 participants. Both were conducted in the United States.
Yes, NurOwn is also known as MSC-NTF cells. NurOwn (MSC-NTF cells) is the full name used in trial listings and company communications. The two names refer to the same investigational cell therapy developed by Brainstorm Cell Therapeutics.
NurOwn has received Orphan Drug and Fast Track designations from the FDA. These designations are intended to support development of therapies for serious conditions. NurOwn is still investigational and has not been approved by the FDA.