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Aging FrailtyPhase 1/2HERANCT02982915

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

A Phase 1/2 study testing Longeveron Mesenchymal Stem Cells (LMSCs) and Fluzone High Dose Vaccine in people with Aging Frailty, run by Longeveron Inc. at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 to 90 years
Conditions the study is for
Aging Frailty
What is being tested?
Longeveron Mesenchymal Stem Cells (LMSCs) and Fluzone High Dose Vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
6 sitesUnited States
Study dates
Nov 2016to Sep 2022
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 90 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 29Show fewer
  • 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.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Johns Hopkins University

    Baltimore, Maryland, 21224

  • Clinical Research of South Florida

    Coral Gables, Florida, 33134

  • Clinical Physiology Associates

    Fort Myers, Florida, 33912

  • University of Miami

    Miami, Florida, 33136

  • Vista Health Research

    Miami, Florida, 33176

  • Optimal Research LLC

    Rockville, Maryland, 20850

Other trials in United States

About this study

Official title: 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

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.

Read the 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
Being tested
Longeveron Mesenchymal Stem Cells (LMSCs), Fluzone High Dose Vaccine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Longeveron Mesenchymal Stem Cells (LMSCs)Biological

    Also called Lomecel-B

    Intravenously delivered

  • Fluzone High Dose VaccineBiological

    Intramuscular injection

Study groups in NCT02982915
Study groupRoleWhat they receive
Pilot Phase- Cohort AExperimentalSingle dose of 20 million Longeveron Mesenchymal Stem Cells (LMSCs) will be delivered followed by vaccination with Fluzone High-Dose at 1 week post-infusion.
Receives: Biological: Longeveron Mesenchymal Stem Cells (LMSCs); Biological: Fluzone High Dose Vaccine
Pilot Phase Cohort B & CExperimentalSingle 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.
Receives: Biological: Longeveron Mesenchymal Stem Cells (LMSCs); Biological: Fluzone High Dose Vaccine
Double-Blind,Randomized,Placebo PhaseExperimental2 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.
Receives: Biological: Longeveron Mesenchymal Stem Cells (LMSCs); Biological: Fluzone High Dose Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 30 days after infusion

  2. 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.

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

Secondary outcomes (17)

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

    Plasma levels of interleukins measured in pg/mL.

    Measured: Baseline, month 6 and month 12 after infusion

  2. Differences in rate of decline from Aging Frailty

    Change in Clinical Frailty rating

    Measured: Baseline, month 6 and month 12 after infusion

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

    Change in risk of falling

    Measured: Baseline, month 6 and month 12 after infusion

  4. PROMIS Short Form 20a questionnaire

    Change in subject quality of life as assessed by participant-reported outcomes.

    Measured: Baseline, month 6 and month 12 after infusion

  5. PROMIS Mobility questionnaire

    Change in subject quality of life as assessed by participant-reported outcomes.

    Measured: Baseline, month 6 and month 12 after infusion

  6. PROMIS Upper Extremity questionnaire

    Change in subject quality of life as assessed by participant-reported outcomes.

    Measured: Baseline, month 6 and month 12 after infusion

  7. Short Form 36 questionnaire

    Change in subject quality of life as assessed by participant-reported outcomes.

    Measured: Baseline, month 6 and month 12 after infusion

  8. IIEF questionnaire

    Change in subject quality of life as assessed by participant-reported outcomes.

    Measured: Baseline, month 6 and month 12 after infusion

  9. SQOL-F questionnaire

    Change in subject quality of life as assessed by participant-reported outcomes.

    Measured: Baseline, month 6 and month 12 after infusion

  10. Death from any cause

    Number of participants that die from any cause while enrolled on the trial and after being treated with LMSCs.

    Measured: Within 12 months after infusion

  11. Falls Efficacy Scale-International (FES-I)

    Change by participant-reported outcomes. Minimum 16 (no concern about falling) to maximum 64 (severe concern about falling)

    Measured: Baseline, month 6 and month 12 after infusion

  12. Changes from baseline between the LMSC and placebo cohorts as assessed by B & T cell levels:

    Plasma levels of B \& T Cells.

    Measured: Baseline, month 6 and month 12 after infusion

  13. Rate of decline in Aging Frailty status as assessed by the 6 minute walk test

    Distance in meters walked in 6 minutes

    Measured: Baseline, month 6 and month 12 after infusion

  14. Rate of decline in Aging Frailty status as assessed by the Short Physical Performance Battery (SPPB)

    Short Physical Performance Battery Assessment

    Measured: Baseline, month 6 and month 12 after infusion

  15. Rate of decline in Aging Frailty status as assessed by the Tinetti POMA Test

    TInetti POMA assessment

    Measured: Baseline, month 6 and month 12 after infusion

  16. Rate of decline in Aging Frailty status as assessed by the Weight Loss

    Weigh measurements at visits

    Measured: Baseline, month 6 and month 12 after infusion

  17. Rate of decline in Aging Frailty status as assessed by the Handgrip Test

    Handgrip strength via dynamometer.

    Measured: Baseline, month 6 and month 12 after infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2016 (estimated)
  2. Study startNov 2016
  3. Primary completionSep 2021
  4. Study completionSep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02982915
Sponsor's protocol ID
00-0000-03
Acronym
HERA
Status last verified
Nov 2022
First submitted
17 Nov 2016
Last updated
4 Nov 2022
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Longeveron Mesenchymal Stem Cells (LMSCs) and Fluzone High Dose Vaccine in people with Aging Frailty, run by Longeveron Inc. at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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: (time frame: 30 days after infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02982915.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2022.

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