Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Allogeneic MSC · 1 trial · 1 indication
To demonstrate that Lomecel-B infusions do not trigger the pre-specified stopping rules. Additional safety will be acquired throughout the study as follows: Incidence of all AEs and SAEs over the course of the trial.
To demonstrate that Lomecel-B infusions do not trigger the pre-specified stopping rules. Additional safety will be acquired throughout the study as follows: Alzheimer's disease-related imaging abnormalities (ARIA) or clinically asymptomatic microhemorrhages as revealed by MRI.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Group 1 will receive four infusions of Placebo on Day 0, Week 4, Week 8, and Week 12. |
| Lomecel-B Dose 1 | EXPERIMENTAL | Group 2 will receive an infusion of Lomecel-B at a dose of 25 x 10\^6 cells (25M) on Day 0, followed by Placebo infusions at Week 4, Week 8, and Week 12. |
| Lomecel-B Dose 2 | EXPERIMENTAL | Group 3 will receive four infusions of 25M Lomecel-B on Day 0, Week 4, Week 8, and Week 12. |
| Lomecel-B Dose 3 | EXPERIMENTAL | Group 4 will receive four infusions of Lomecel-B at a dose of 100 x 10\^6 cells (100M) on Day 0, Week 4, Week 8, and Week 12. |
| Name | Type | Description |
|---|---|---|
| Allogeneic MSC | DRUG | An allogeneic bone marrow-derived medicinal signaling cell (MSC) formulation |
| Placebo | OTHER | Placebo |
Inclusion Criteria: * Provide written informed consent. * Be 60 - 85 years of age at signing of the Informed Consent Form. * Clinical diagnosis of mild Alzheimer's disease in accordance with the NIA-AA criteria at the time of enrollment. * MMSE score of 19 - 23. * Body weight of 40 - 150 kg. * Has ...
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Allogeneic MSC is an investigational therapy being studied for the treatment of Mild Alzheimer's Disease. It is currently in Phase 2 clinical development. The therapy is being evaluated in a completed clinical trial that enrolled 50 participants with this condition.
Allogeneic MSC is being developed by Longeveron Inc., a biopharmaceutical company. Longeveron Inc. is publicly traded under the ticker symbol LGVN. The company is conducting clinical research to evaluate this therapy for Mild Alzheimer's Disease.
Allogeneic MSC is in Phase 2 clinical development. It is an investigational therapy, meaning it has not been approved by regulatory authorities. A Phase 2 clinical trial for this therapy has been completed, with results expected to inform further development.
Allogeneic MSC has been studied in one clinical trial with the identifier NCT05233774, titled 'Lomecel-B Effects on Alzheimer's Disease'. This was a Phase 2, randomized, double-blind, placebo-controlled trial conducted in the United States, enrolling 50 participants with Mild Alzheimer's Disease.
Yes, Allogeneic MSC is also known as Lomecel-B. The clinical trial NCT05233774, which evaluated this therapy for Mild Alzheimer's Disease, is titled 'Lomecel-B Effects on Alzheimer's Disease'. Both names refer to the same investigational therapy being developed by Longeveron Inc.