Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs)
Allogeneic Human Mesenchymal Stem Cells · 1 trial · 1 indication
Incidence of any treatment-emergent serious adverse events (SAE), defined as the composite of: death, non-fatal pulmonary embolism, stroke, hospitalization for worsening dyspnea and clinically significant laboratory test abnormalities. * Serum chemistry: chloride, bicarbonate, blood urea nitrogen (BUN), creatinine, glucose, calcium, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin (fractionate if total \>1.5 times normal), alkaline phosphatase, albumin, * Hematology (Complete blood count): hemoglobin, hematocrit, platelets, white blood cells (WBC), WBC differential
| Arm | Type | Description |
|---|---|---|
| Pilot phase - Group 1 | EXPERIMENTAL | Group 1 participants will receive Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 20 million allo-hMSCs/kg delivered via peripheral intravenous infusion. Participants in this group have the option to receive an additional 3 infusions of 100million allo-hMSCs/kg per infusion with a 12 to 18 month interval. |
| Pilot Phase - Group 2 | EXPERIMENTAL | Group 2 - Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 100 million allo-hMSCs/kg delivered via peripheral intravenous infusion. Participants in this group have the option to receive an additional 3 infusions of 100million allo-hMSCs/kg per infusion with a 12 to 18 month interval. |
| Pilot Phase - Group 3 | EXPERIMENTAL | Group 3 - Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 200 million allo-hMSCs/kg delivered via peripheral intravenous infusion. Participants in this group have the option to receive an additional 3 infusions of 100million allo-hMSCs/kg per infusion with a 12 to 18 month interval. |
| Randomized Phase - Group A | EXPERIMENTAL | Group A - Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 100 million allo-hMSCs/kg delivered via peripheral intravenous infusion. |
| Randomized phase - Group B | EXPERIMENTAL | Group B - Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 200 million allo-hMSCs/kg delivered via peripheral intravenous infusion. |
| Randomized Phase - Group C | EXPERIMENTAL | Group C - Placebo delivered via peripheral intravenous infusion. Participants in this group have the option to receive one additional infusion of 100million allo-hMSCs/kg with a 12 to 18 month interval. |
| Addendum B - Antibiotic free cell Group | EXPERIMENTAL | Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs): 100 million penicillin/streptomycin-free allo-hMSCs/kg delivered via peripheral intravenous infusion. Participants in this group have the option to receive an additional 3 infusions of 100million allo-hMSCs/kg per infusion with a 12 to 18 month interval. |
| Name | Type | Description |
|---|---|---|
| Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) | BIOLOGICAL | Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion |
| Placebo | BIOLOGICAL | Placebo administered by peripheral intravenous infusion. |
| Penicillin/Streptomycin-Free Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) | BIOLOGICAL | Penicillin/Streptomycin-Free Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion. |
Inclusion Criteria: * Provide written informed consent. * Subjects age greater than or equal to 60 and less than or equal to 95 years at the time of signing the Informed Consent Form. * Show signs of frailty apart from a concomitant condition as assessed by the Investigator with a frailty score of ...