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Mesenchymal Precursor Cells · 3 trials · 3 indications
Outcomes include the following safety parameters: * Number of and percent of subject with adverse events and serious adverse events * Clinically significant values and shifts from baseline in vital signs, physical examinations and electrocardiograms * Clinical laboratory tests (hematology, chemistry and urinalysis, flow cytometry with Class I and Class II PRA % with specificity)
Outcomes include the measurement of the following safety parameters: * Adverse events and serious adverse events(including hypoglycemia) * Vital signs (BP, HR, RR, O2 saturation) * Physical examinations * Results of clinical laboratory tests (hematology, biochemistry, and urinalysis, flow cytometry Class I and Class II PRA % with specificity, antibovine and antimurine antibody analysis) * Pulmonary function test * Electrocardiograms * Chest X-ray * Fundus oculi examination
| Arm | Type | Description |
|---|---|---|
| A1 | ACTIVE_COMPARATOR | 15 subjects randomized to receive 25 M allogeneic MPCs by transendocardial injection and mapping. |
| A2 | SHAM_COMPARATOR | 5 subjects randomized to receive standard-of-care treatment with mock mapping and injection procedures. |
| B1 | ACTIVE_COMPARATOR | 15 subjects randomized to receive 75 M allogeneic MPCs by transendocardial injection and mapping. |
| B2 | SHAM_COMPARATOR | 5 subjects randomized to receive standard-of-care treatment with mock mapping and injection procedures. |
| C1 | ACTIVE_COMPARATOR | 15 subjects randomized to receive 150 M allogeneic MPCs by transendocardial injection and mapping. |
| C2 | SHAM_COMPARATOR | 5 subjects randomized to receive standard-of-care treatment with mock mapping and injection procedures. |
| Cohort 1 | EXPERIMENTAL | Mesenchymal Precursor Cells (MPCs) - Dose 1 or Placebo |
| Cohort 2 | EXPERIMENTAL | Mesenchymal Precursor Cells (MPCs) - Dose 2 or Placebo |
| Cohort 3 | EXPERIMENTAL | MPC dose 3 or Placebo |
| Name | Type | Description |
|---|---|---|
| Mesenchymal Precursor Cells (MPCs) | BIOLOGICAL | 25 M allogeneic MPCs by transendocardial injection and mapping. |
| standard-of-care treatment with mock mapping and injection procedures. | PROCEDURE | Mock |
Inclusion Criteria: 1. NYHA ≥ 2. 2. Age \>20 and \<80. 3. Cardiomyopathy of ischemic or idiopathic etiology. 4. Subject is not a candidate for either percutaneous intervention or cardiac surgery as determined by both an interventional cardiologist and a cardiac surgeon. 5. LVEF (Left ventricular ej...
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Mesenchymal Precursor Cells is an investigational cell therapy being studied for diabetic nephropathy, type 2 diabetes, and heart failure. It is developed by Mesoblast Limited (MESO) and is currently in Phase 1 clinical development for these metabolic and cardiovascular conditions.
Mesenchymal Precursor Cells is developed by Mesoblast Limited, a biopharmaceutical company listed on the stock exchange under the ticker MESO. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational cell therapy in various patient populations.
Mesenchymal Precursor Cells is in Phase 1 clinical development. While one completed trial was a Phase 2 study in heart failure, the current development stage for the drug is Phase 1, with ongoing or completed early-stage trials in type 2 diabetes and diabetic nephropathy.
Mesenchymal Precursor Cells has been studied in three completed clinical trials: NCT00721045, a Phase 2 dose-escalation study in heart failure; NCT01576328, a Phase 1 safety study in type 2 diabetes; and NCT01843387, a Phase 1 safety and efficacy study in diabetic nephropathy.
Mesenchymal Precursor Cells is not FDA approved. It is an investigational drug still in clinical development, with completed trials but no approval status indicated. The drug is being studied for safety and efficacy in conditions like heart failure, type 2 diabetes, and diabetic nephropathy.