Phase 1/2Completed
Lomecel-B on Vaccine-Specific Antibody- Response in Subjects With Aging Frailty (HERA)
Effects of Intravenous Delivery of Lomecel-B (Formerly Allogenic Longeveron Human Mesenchymal Stem Cells (LMSCs)) on VaccinE-Specific Antibody Responses in Subjects With Aging Frailty
- Sponsor
- Longeveron Inc. (Industry)
- Enrolment
- 62 enrolled
- Conditions
- Aging Frailty
- Interventions
- Longeveron Mesenchymal Stem Cells (LMSCs); Fluzone High Dose Vaccine
- Ages
- older adults
- Registry
- NCT02982915
From the registry
This is a phase I/II, randomized, blinded and placebo-controlled study to test the safety and efficacy of Lomecel-B for improving vaccine immune response.
Primary outcomes
- The incidence of any treatment-emergent serious adverse event (TE-SAE), defined as one or more of the following untoward medical occurrences within 30 days after infusion as assessed by the following:
- The ability of Lomecel-B (LMSC) treatment to improve inactivation of influenza virus as assessed by validated hemagglutination inhibition (HAI) assays.