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MSC-NTF cells transplantation · 1 trial · 1 indication
Safety evaluation and tolerability of a single treatment administration of autologous cultured mesenchymal bone marrow stromal cells secreting neurotrophic factors (MSC-NTF) by multiple intramuscular injections (IM) at 24 separate sites on the biceps and triceps muscles to patients with ALS at the early disease stage
Safety evaluation and tolerability of single intrathecal injection (IT) into the cerebrospinal fluid (CSF) of autologous cultured mesenchymal bone marrow stromal cells secreting neurotrophic factors (MSC-NTF),to patients with ALS at the progressive disease stage.
| Arm | Type | Description |
|---|---|---|
| MSC-NTF cells IM | EXPERIMENTAL | Intramuscular administration in early stage patients |
| MSC-NTF cells IT | EXPERIMENTAL | Intrathecal administration in progressive stage patients |
| Name | Type | Description |
|---|---|---|
| MSC-NTF cells transplantation (IM) | BIOLOGICAL | In early ALS subjects: Autologous MSC-NTF cells will be transplanted under mild anesthesia, intramuscularly into patients' clinically unaffected (or only mildly affected) upper arm biceps and triceps muscles according to a pre-designed grid. Intramuscular injections will be by a 26 gauge needle to a 1.5cm depth (ensuring that injection is into muscle and not adipose tissue). The patients will be injected at 24 sites with a total of 24 million cells |
| MSC-NTF cells transplantation (IT) | BIOLOGICAL | In progressive ALS subjects: Autologous MSC-NTF cells will be transplanted under mild anesthesia intrathecally(via a standard lumbar puncture)with a total of 60 million cells. |
Inclusion Criteria: 1. El Escorial criteria for definite or probable ALS 2. Either men or non pregnant women between 20-75 years of age. 3. Patient is mentally intact and psychologically stable 4. For early stage ALS- Patients will be with ALS-FRS-R scale of at least 30 and disease duration of less...
MSC-NTF cells transplantation is an investigational cell therapy being studied for the treatment of Amyotrophic Lateral Sclerosis (ALS). It involves transplanting autologous cultured mesenchymal bone marrow stromal cells that secrete neurotrophic factors. The therapy is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
MSC-NTF cells transplantation does not target a specific molecular target. Instead, it uses mesenchymal bone marrow stromal cells that have been cultured to secrete neurotrophic factors, which are proteins that support the growth, survival, and function of neurons. This approach aims to provide neuroprotective support to motor neurons affected by ALS.
MSC-NTF cells transplantation 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, with this therapy being one of its lead candidates for ALS.
MSC-NTF cells transplantation is in Phase 1 clinical development. It has completed one Phase 1 trial, which was a controlled, non-randomized, open-label study. The therapy is still investigational and has not been approved by the FDA or any other regulatory agency for commercial use.
MSC-NTF cells transplantation has been studied in one completed clinical trial with the identifier NCT01051882. The trial, titled 'Autologous Cultured Mesenchymal Bone Marrow Stromal Cells Secreting Neurotrophic Factors (MSC-NTF), in ALS Patients,' enrolled 12 participants with Amyotrophic Lateral Sclerosis in Israel. The study was a Phase 1, controlled, open-label trial.
MSC-NTF cells transplantation is not listed as being the same as NurOwn in the available information. While both are cell therapies developed by Brainstorm Cell Therapeutics for ALS, the data provided does not indicate that they are alternative names for the same product. Readers should consult official sources for clarification on product naming.