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 ...
Allogeneic Human Mesenchymal Stem Cells is an investigational cell therapy being studied for frailty, a geriatric syndrome marked by reduced strength and physiologic reserve. It is delivered intravenously and was evaluated in patients aged 60 years and older. It is not an approved treatment.
Longeveron Inc., which trades under the ticker LGVN, is the developer of Allogeneic Human Mesenchymal Stem Cells. The company sponsored the clinical program evaluating this cell therapy in patients with frailty.
Allogeneic Human Mesenchymal Stem Cells is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The single registered trial of this therapy has completed, and no trials are currently active.
Allogeneic Human Mesenchymal Stem Cells was studied in one completed trial, NCT02065245, titled AllogeneiC Human Mesenchymal Stem Cells (hMSC) in Patients With Aging FRAilTy Via IntravenoUS Delivery. The Phase 1 trial enrolled 65 patients with frailty in the United States and used a randomized, double-blind, controlled design.
Yes. Allogeneic Human Mesenchymal Stem Cells is also referred to as allo-hMSCs, an abbreviation for the same cell therapy developed by Longeveron Inc. Both names describe the same investigational product studied in frailty.
The Phase 1 trial NCT02065245 was a randomized, double-blind, controlled study of Allogeneic Human Mesenchymal Stem Cells in frailty. It enrolled 65 participants aged 60 years and older of any sex, excluded healthy volunteers, and was conducted in the United States. The trial has completed.