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 (HERA)

NCT02982915 Phase 1/Phase 2 COMPLETED

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.

Details

Lead sponsor	Longeveron Inc.
Phase	Phase 1/Phase 2
Status	COMPLETED
Enrolment	62
Start date	2016-11
Completion	2022-09

Conditions

• Aging Frailty

Interventions

• Longeveron Mesenchymal Stem Cells (LMSCs)
• Fluzone High Dose Vaccine

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: — 30 days after infusion
  * Is life-threatening (e.g., stroke or non-fatal pulmonary embolism). * Requires inpatient hospitalization or prolongation of existing hospitalization. * Results in persistent or significant disability/incapacity. * Results in death * Results in other clinically significant untoward laboratory test result(s) or medical condition(s), determined per Investigator's judgment.
• The ability of Lomecel-B (LMSC) treatment to improve inactivation of influenza virus as assessed by validated hemagglutination inhibition (HAI) assays. — Baseline Visit, Vaccination Visits, Weeks 1, 2, 4, Month 6 and Month 12 Follow-Up Visits.
  Measurements of validated hemagglutination inhibition (HAI) assays at follow up visits.

Countries

United States