Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Nurown MSC-NTF cells · 1 trial · 1 indication
Safety assessed based on the incidence of treatment-emergent adverse events (TEAEs) (including serious adverse events \[SAEs\]) including clinically relevant changes in vital signs, clinical laboratory assessments, physical and neurological examinations, and electrocardiogram (ECG) tests, during transplantation of expanded autologous MSC-NTF cells administered on a single occasion via combined intrathecal (IT) administration and intramuscular (IM) injections
| Arm | Type | Description |
|---|---|---|
| Nurown MSC-NTF cells | ACTIVE_COMPARATOR | Single autologous MSC-NTF cells treatment by combined intramuscular and intrathecal administration |
| Excipient | PLACEBO_COMPARATOR | Combined intramuscular and intrathecal placebo administration |
| Name | Type | Description |
|---|---|---|
| Nurown MSC-NTF cells | BIOLOGICAL | Single autologous MSC-NTF cells treatment by combined intramuscular and intrathecal administration |
| Placebo | BIOLOGICAL | Excipient administration by combined intramuscular and intrathecal administration |
Inclusion Criteria 1. Males and females ages 18 to 75 years old, inclusive. 2. ALS diagnosed as possible, laboratory-supported probable, probable, or definite as defined by revised El Escorial criteria. 3. Disease onset, as defined by first reported occurrence of symptomatic weakness, spasticity, o...
NurOwn MSC-NTF cells is an investigational cell therapy being studied for the treatment of Amyotrophic Lateral Sclerosis (ALS), a progressive neurodegenerative disease. It is currently in clinical development and has not been approved by regulatory authorities.
NurOwn MSC-NTF cells is a mesenchymal stem cell therapy that is engineered to secrete neurotrophic factors, which are proteins that support the survival and function of neurons. The therapy is designed to deliver these factors directly to the site of neurodegeneration in ALS patients.
NurOwn MSC-NTF cells is being developed by Brainstorm Cell Therapeutics Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol BCLI. The company is focused on developing cellular therapies for neurodegenerative diseases.
NurOwn MSC-NTF cells is in Phase 2 clinical development. It has completed a Phase 2 trial in patients with ALS, and it remains an investigational therapy that has not received regulatory approval for commercial use.
NurOwn MSC-NTF cells has been studied in one completed Phase 2 clinical trial, registered as NCT02017912. This was a randomized, double-blind, placebo-controlled multicenter study that enrolled 48 participants with ALS in the United States.
Yes, NurOwn MSC-NTF cells is also referred to as MSC-NTF cells. The therapy consists of autologous mesenchymal stem cells that have been induced to secrete neurotrophic factors, and it is being investigated as a potential treatment for ALS.