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

NCT02982915 | Completed Phase 1 DMC

• 1 other identifier: 00-0000-03
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 6

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.

Conditions

Aging Frailty

Outcome Measures

Primary Outcomes (2)

• 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:

  * 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.

  30 days after infusion

• The ability of Lomecel-B (LMSC) treatment to improve inactivation of influenza virus as assessed by validated hemagglutination inhibition (HAI) assays.

  Measurements of validated hemagglutination inhibition (HAI) assays at follow up visits.

  Baseline Visit, Vaccination Visits, Weeks 1, 2, 4, Month 6 and Month 12 Follow-Up Visits.

Secondary Outcomes (17)

• Changes from baseline between the LMSC and placebo cohorts as assessed by plasma cytokine levels:

  Baseline, month 6 and month 12 after infusion

• Differences in rate of decline from Aging Frailty

  Baseline, month 6 and month 12 after infusion

• Assessed by the Falls Efficacy Scale-International and Performance Oriented Mobility Assessment

  Baseline, month 6 and month 12 after infusion

• PROMIS Short Form 20a questionnaire

  Baseline, month 6 and month 12 after infusion

• PROMIS Mobility questionnaire

  Baseline, month 6 and month 12 after infusion

Study Arms (3)

Pilot Phase- Cohort A

EXPERIMENTAL

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.

Biological: Longeveron Mesenchymal Stem Cells (LMSCs); Biological: Fluzone High Dose Vaccine

Pilot Phase Cohort B & C

EXPERIMENTAL

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.

Biological: Longeveron Mesenchymal Stem Cells (LMSCs); Biological: Fluzone High Dose Vaccine

Double-Blind,Randomized,Placebo Phase

EXPERIMENTAL

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.

Biological: Longeveron Mesenchymal Stem Cells (LMSCs); Biological: Fluzone High Dose Vaccine

Interventions

Longeveron Mesenchymal Stem Cells (LMSCs) BIOLOGICAL

Intravenously delivered

Also known as: Lomecel-B

Double-Blind,Randomized,Placebo Phase; Pilot Phase Cohort B & C; Pilot Phase- Cohort A

Fluzone High Dose Vaccine BIOLOGICAL

Intramuscular injection

Double-Blind,Randomized,Placebo Phase; Pilot Phase Cohort B & C; Pilot Phase- Cohort A

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Longeveron Inc.: lead

Study Sites (6)

Clinical Research of South Florida

Coral Gables, Florida, 33134, United States

Location

Clinical Physiology Associates

Fort Myers, Florida, 33912, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Vista Health Research

Miami, Florida, 33176, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21224, United States

Location

Optimal Research LLC

Rockville, Maryland, 20850, United States

Location

MeSH Terms

Interventions

Influenza Vaccines; Vaccines

Intervention Hierarchy (Ancestors)

Viral Vaccines; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2016
• First Posted: December 6, 2016
• Study Start: November 1, 2016
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2022
• Last Updated: November 4, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)