Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05233774 | Lomecel-B Effects on Alzheimer's Disease | PHASE2 | COMPLETED | 50 | — | — | Dec 28, 2021 | Sep 29, 2023 | Feb 20, 2024 | 13 | United States |
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 ...