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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04476901 | Administration of Allogeneic-MSC in Patients With Non-Ischemic Dilated Cardiomyopathy | PHASE2 | RECRUITING | 136 | — | — | May 7, 2021 | Apr 1, 2027 | Mar 24, 2026 | 4 | United States |
Change in Left Ventricular Ejection Fraction (LVEF) as assessed via cardiac Magnetic Resonance Imaging (MRI)
| Arm | Type | Description |
|---|---|---|
| Genotype A administered with placebo Group | PLACEBO_COMPARATOR | Participants whose blood genotyping resulted with Genotype A (absence of any variant/ presence of benign variant) and randomized to the placebo group will receive the placebo intervention. |
| Genotype A administered with hMSC Group | EXPERIMENTAL | Participants whose blood genotyping resulted with Genotype A (absence of any variant/ presence of benign variant) and randomized to the treatment group will receive the hMSC intervention. |
| Genotype B administered with placebo Group | PLACEBO_COMPARATOR | Participants whose blood genotyping resulted with Genotype B (variants of uncertain significance) and randomized to the placebo group will receive the placebo intervention. |
| Genotype B administered with hMSC Group | EXPERIMENTAL | Participants whose blood genotyping resulted with Genotype B (variants of uncertain significance) and randomized to the treatment group will receive the hMSC intervention. |
| Genotype C administered with placebo Group | PLACEBO_COMPARATOR | Participants whose blood genotyping resulted with Genotype C (pathogenic or likely pathogenic variants) and randomized to the placebo group will receive the placebo intervention. |
| Genotype C administered with hMSC Group | EXPERIMENTAL | Participants whose blood genotyping resulted with Genotype C (pathogenic or likely pathogenic variants) and randomized to the treatment group will receive the hMSC intervention. |
| Name | Type | Description |
|---|---|---|
| allogeneic human mesenchymal stem cells (hMSCs) | BIOLOGICAL | allo-hMSCs, 16-20 million cells/ml delivered at a dose of 0.5 ml/ injection x 10 injections for a total of 80-100 million allo-hMSCs or a single administration of intravenous allogeneic hMSCs (100 million). |
| Placebo | OTHER | Placebo will be administered as injections of plasmalyte A supplemented with 1% of 25% human serum albumin (HSA). 0.5 ml/ injection x 10 injections or an intravenous placebo infusion of Cell-free PlasmaLyte-A medium supplemented with 1% of 25% human serum albumin (HSA) |
Inclusion Criteria: In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Men and women aged 18 to 80 years (inclusive) at the time of signing the informed consent form. 2. Diagnosis of NIDCM with left ventricular ejection fraction ≤45%. 3....