Lomecel-B on Vaccine-Specific Antibody- Response in Subjects With Aging Frailty

NCT ID: NCT02982915

Last Updated: 2022-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2022-09-30

Brief Summary

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.

Detailed Description

A pilot phase will consist of a 3 subject safety run-in, followed by 20 subject randomized phase to evaluate influenza vaccine response at 1 week and 4 weeks post infusion of Lomecel-B (Formerly LMSCs). This will be followed by a double-blinded, randomized, placebo-controlled phase.

Conditions

Aging Frailty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Pilot Phase- Cohort A

Single dose of 20 million Longeveron Mesenchymal Stem Cells (LMSCs) will be delivered followed by vaccination with Fluzone High-Dose at 1 week post-infusion.

Group Type: EXPERIMENTAL

Longeveron Mesenchymal Stem Cells (LMSCs)

Intervention Type: BIOLOGICAL

Intravenously delivered

Fluzone High Dose Vaccine

Intervention Type: BIOLOGICAL

Intramuscular injection

Pilot Phase Cohort B & C

Single dose of 100 million Longeveron Mesenchymal Stem Cells (LMSCs) followed by vaccination with Fluzone High-Dose at either 1 week (Cohort B) or 4 weeks (Cohort C) post infusion.

Group Type: EXPERIMENTAL

Longeveron Mesenchymal Stem Cells (LMSCs)

Intervention Type: BIOLOGICAL

Intravenously delivered

Fluzone High Dose Vaccine

Intervention Type: BIOLOGICAL

Intramuscular injection

Double-Blind,Randomized,Placebo Phase

2 cohorts to receive a single infusion of 100 million Longeveron Mesenchymal Stem Cells (LMSCs) (Cohort A: 30 subjects) or placebo (Cohort B:30 subjects) followed by vaccination with Fluzone High-Dose.

Group Type: EXPERIMENTAL

Longeveron Mesenchymal Stem Cells (LMSCs)

Intervention Type: BIOLOGICAL

Intravenously delivered

Fluzone High Dose Vaccine

Intervention Type: BIOLOGICAL

Intramuscular injection

Interventions

Longeveron Mesenchymal Stem Cells (LMSCs)

Intravenously delivered

Intervention Type: BIOLOGICAL

Fluzone High Dose Vaccine

Intramuscular injection

Intervention Type: BIOLOGICAL

Other Intervention Names

Lomecel-B

Eligibility Criteria

Inclusion Criteria

• be willing and able to provide written informed consent and comply with all procedures required by the protocol.
• be 65 - 90 years of age at the time of signing the Informed Consent Form.
• have a diagnosis of Aging Frailty, with a score of 4 to 7 using the Canadian Frailty Scale.
• have a six-minute walk test (6MWT) distance of 200m - 400m for each of 2 trials, and the 2 trials must be within 15% of each other.
• have total bilirubin between 0.3 - 1.9 mg/dL.

Exclusion Criteria

• be unwilling or unable to perform any of the assessments required by the Protocol.
• score ≤24 on the Mini Mental State Examination (MMSE).
• have previously received current year's flu-vaccine.
• have any contraindication to receiving a vaccine.
• have a Hemoglobin A1c (HbA1c) level >9.0%.
• be diagnosed with malignancy (subjects without a recurrence in the last 2.5 years will be allowed) except curatively-treated basal cell carcinoma, melanoma in situ, or cervical carcinoma.
• have a condition that projected to limit the life-expectancy to ≤1 year.
• have autoimmune disease (e.g., rheumatoid arthritis).
• be using medication(s) known to alter immune response, e.g., high-dose corticosteroids.
• have HIV, AIDS, or other immunodeficiency.
• test positive for hepatitis B virus

• If the subject tests positive for anti-HBc or anti-HBs, they must be receiving treatment for Hepatitis B virus prior to infusion and remain on treatment throughout the study.
• test positive for viremic hepatitis C, HIV1, HIV2, or syphilis.
• have a resting blood oxygen saturation of <93% (measured by pulse oximetry).
• be a female who is pregnant, nursing, or of childbearing potential while not practicing effective contraception.
• have documented current substance and/or alcohol abuse.
• have known allergies to latex or eggs.
• have a known hypersensitivity to dimethyl sulfoxide (DMSO).
• be an organ transplant recipient (other than corneal, bone, skin, ligament, or tendon transplant).
• be actively listed (or expected to be listed) for transplant of any organ (other than corneal, bone, skin, ligament, or tendon transplant).
• have any clinically important abnormal screening laboratory values, including but not limited to:

• hemoglobin <10.0 g/dL.
• white blood cell count < 2500/mm3.
• platelets < 100,000/mm3.
• prothrombin time/international normalized ratio (PT/INR) ˃ 1.5 not due to a reversible cause (i.e. Coumadin).
• aspartate transaminase, alanine transaminase, or alkaline phosphatase ˃ 2 times upper limit of normal.
• have a sitting or resting systolic blood pressure >180 mm Hg or diastolic blood pressure >110 mm Hg at Screening.
• have any serious illness or any other condition that, in the opinion of the investigator, may compromise the safety or compliance of the subject or preclude successful completion of the study, or that may compromise the validity of the study.
• be currently participating in an investigational therapeutic or device trial, or have participated in an investigational therapeutic or device trial within the previous 30 days, or participate in any other clinical trial for the duration of the time that the subject actively participates in this trial.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Longeveron Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinical Research of South Florida

Coral Gables, Florida, United States

Clinical Physiology Associates

Fort Myers, Florida, United States

University of Miami

Miami, Florida, United States

Vista Health Research

Miami, Florida, United States

Johns Hopkins University

Baltimore, Maryland, United States

Optimal Research LLC

Rockville, Maryland, United States

Countries

United States

Other Identifiers

00-0000-03

Identifier Type: -

Identifier Source: org_study_id