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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 an investigational cell therapy being developed for amyotrophic lateral sclerosis (ALS) and chronic progressive multiple sclerosis. It is a mesenchymal stem cell-based treatment that secretes neurotrophic factors. NurOwn is not approved by the FDA and remains in clinical development.
NurOwn is being developed by Brainstorm Cell Therapeutics Inc., a biopharmaceutical company traded on the Nasdaq under the ticker BCLI. The company is focused on developing cellular therapies for neurodegenerative diseases.
NurOwn has completed a Phase 3 clinical trial for ALS and a Phase 2 clinical trial for progressive multiple sclerosis. Both trials are completed, and the therapy is still investigational, meaning it has not received FDA approval.
NurOwn has been studied in two completed clinical trials. The Phase 3 trial NCT03280056 evaluated repeated administrations of NurOwn in 196 ALS patients in the United States. The Phase 2 trial NCT03799718 assessed NurOwn in 23 participants with chronic progressive multiple sclerosis.
NurOwn is a cell therapy that uses mesenchymal stem cells that have been induced to secrete neurotrophic factors. These factors are intended to support and protect motor neurons, which are damaged in ALS. The therapy is designed to deliver these factors directly to the site of neurodegeneration.
Yes, NurOwn is also known as MSC-NTF cells, which stands for mesenchymal stem cells secreting neurotrophic factors. This name reflects the mechanism of the therapy, where stem cells are engineered to produce and release factors that support neuronal health.