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administration of 1 million of MSC · 1 trial · 1 indication
To evaluate the safety of the intravenous administration of 3 doses of autologous mesenchymal stem cells (MSC) from adipose tissue in patients with Amyotrophic lateral Sclerosis (ALS) ABSENCE of: complications in the place of the infusion, appearance of a new neurological effect not attributable to the natural progression of this pathology and adverse serious unexpected reactions or not, attributable to the treatment (SUSSARs or SAE)
To evaluate the safety of the intravenous administration of 3 doses of autologous
To evaluate the safety of the intravenous administration of 3 doses of autologous
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Intravenous administration of placebo |
| 1 million of MSC | EXPERIMENTAL | Intravenous administration of 1 million of MSC/ kg |
| 2 million of MSC | EXPERIMENTAL | Intravenous administration of 2 million of MSC/ kg |
| 4 million of MSC | EXPERIMENTAL | Intravenous administration of 4 million of MSC/ kg |
| Name | Type | Description |
|---|---|---|
| Intravenous administration of placebo | OTHER | - |
| Intravenous administration of 1 million of MSC | DRUG | - |
| Intravenous administration of 2 million of MSC | DRUG | - |
| Intravenous administration of 4 million of MSC | DRUG | - |
Inclusion Criteria: 1. Women and males over 18-year-old. 2. Good understanding of the protocol and aptitude to grant the informed assent. 3. Diagnosis of sporadic ALS, with diagnosis of certainty, that is to say, definite or probable, in agreement with the criteria of "El Escorial", of the World Fe...
Administration of 1 million of MSC is used for Amyotrophic Lateral Sclerosis (ALS), a progressive neurodegenerative disease affecting nerve cells in the brain and spinal cord. It is an investigational small molecule being developed by Design Therapeutics, Inc. for this indication.
Design Therapeutics, Inc. (NASDAQ: DSGN) is developing administration of 1 million of MSC. The company is conducting clinical research on this investigational therapy for Amyotrophic Lateral Sclerosis.
Administration of 1 million of MSC is in Phase 1 clinical development. It is an investigational therapy, not yet approved by regulatory authorities, and is being studied for safety and efficacy in patients with Amyotrophic Lateral Sclerosis.
Administration of 1 million of MSC has one completed clinical trial, NCT02290886, a multicenter Phase I/II study evaluating safety in patients with Amyotrophic Lateral Sclerosis. The trial enrolled 52 participants in Spain and was placebo-controlled and double-blind.
Administration of 1 million of MSC is not FDA approved. It is an investigational therapy currently in Phase 1 clinical development for Amyotrophic Lateral Sclerosis, meaning it has not yet been authorized for commercial use.