Human Mesenchymal Stem Cells (LMSCs) on Vaccine-Specific Antibody- Response in Subjects With Aging Frailty (HERA)
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ClinicalTrials.gov Identifier: NCT02982915 |
Recruitment Status :
Recruiting
First Posted : December 6, 2016
Last Update Posted : March 13, 2020
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Condition or disease | Intervention/treatment | Phase |
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Aging Frailty | Biological: Longeveron Mesenchymal Stem Cells (LMSCs) Biological: Fluzone High Dose Vaccine | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 83 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Effects of Intravenous Delivery of Longeveron Human Mesenchymal Stem Cells (LMSCs) on Vaccine-Specific Antibody Responses in Subjects With Aging Frailty |
Study Start Date : | November 2016 |
Estimated Primary Completion Date : | April 2021 |
Estimated Study Completion Date : | August 2021 |
Arm | Intervention/treatment |
---|---|
Experimental: 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.
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Biological: Longeveron Mesenchymal Stem Cells (LMSCs)
Intravenously delivered Biological: Fluzone High Dose Vaccine Intramuscular injection |
Experimental: 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.
|
Biological: Longeveron Mesenchymal Stem Cells (LMSCs)
Intravenously delivered Biological: Fluzone High Dose Vaccine Intramuscular injection |
Experimental: 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.
|
Biological: Longeveron Mesenchymal Stem Cells (LMSCs)
Intravenously delivered Biological: Fluzone High Dose Vaccine Intramuscular injection |
- 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 ]
- 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.
- Prevention of the illness caused by any influenza viral type/subtype in association with influenza like symptoms: [ Time Frame: Within 7 months after vaccination ]Number of participants with sore throat, cough, sputum production, wheezing or difficulty breathing concurrent with fever, chills, tiredness, headaches and myalgia.
- Changes from baseline between the LMSC and placebo cohorts as assessed by plasma cytokine levels: [ Time Frame: Month 6 and month 12 after infusion ]Plasma levels of interleukins measured in pg/mL.
- Differences in rate of decline from Aging Frailty [ Time Frame: Baseline, month 6 and month 12 after infusion ]Change in Clinical Frailty rating
- Assessed by the Falls Efficacy Scale-International and Performance Oriented Mobility Assessment [ Time Frame: Baseline, month 6 and month 12 after infusion ]Change in risk of falling
- PROMIS Short Form 20a questionnaire [ Time Frame: Baseline, month 6 and month 12 after infusion ]Change in subject quality of life as assessed by participant-reported outcomes.
- PROMIS Mobility questionnaire [ Time Frame: Baseline, month 6 and month 12 after infusion ]Change in subject quality of life as assessed by participant-reported outcomes.
- PROMIS Upper Extremity questionnaire [ Time Frame: Baseline, month 6 and month 12 after infusion ]Change in subject quality of life as assessed by participant-reported outcomes.
- Short Form 36 questionnaire [ Time Frame: Baseline, month 6 and month 12 after infusion ]Change in subject quality of life as assessed by participant-reported outcomes.
- IIEF questionnaire [ Time Frame: Baseline, month 6 and month 12 after infusion ]Change in subject quality of life as assessed by participant-reported outcomes.
- SQOL-F questionnaire [ Time Frame: Baseline, month 6 and month 12 after infusion ]Change in subject quality of life as assessed by participant-reported outcomes.
- Death from any cause [ Time Frame: Within 12 months after infusion ]Number of participants that die from any cause while enrolled on the trial and after being treated with LMSCs.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 65 Years to 90 Years (Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
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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).
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02982915
Contact: Anthony Oliva, PhD | (305) 909-0840 | aoliva@longeveron.com | |
Contact: Geoff Green | (305) 909-0840 | ggreen@longeveron.com |
United States, Florida | |
Clinical Research of South Florida | Recruiting |
Coral Gables, Florida, United States, 33134 | |
Contact: Julio Gomez, CRC 305-445-5637 ext 245 julio.gomez@amrllc.com | |
Contact: Maria M Rodriguez, RMA-CRT-CCRC (305) 445-5637 ext 229 maria.rodriguez@amrllc.com | |
Principal Investigator: Jeffrey Rosen, MD | |
Clinical Physiology Associates | Recruiting |
Fort Myers, Florida, United States, 33912 | |
Contact: Tammy Viens, RN, BSN 239-936-4424 tammy.viens@amrllc.com | |
Principal Investigator: Pedro P Ylisastigui, MD | |
University of Miami | Active, not recruiting |
Miami, Florida, United States, 33136 | |
Vista Health Research | Active, not recruiting |
Miami, Florida, United States, 33176 | |
United States, Maryland | |
Johns Hopkins University | Recruiting |
Baltimore, Maryland, United States, 21224 | |
Contact: Brian Tanaka btanaka1@jhmi.edu | |
Principal Investigator: Sean Leng, MD, PhD | |
Optimal Research LLC | Recruiting |
Rockville, Maryland, United States, 20850 | |
Contact: Katelyn Janicz 301-309-8611 kjanicz@optimalsites.net | |
Principal Investigator: Peta-Gay Jackson-Booth, MD |
Responsible Party: | Longeveron LLC |
ClinicalTrials.gov Identifier: | NCT02982915 |
Other Study ID Numbers: |
00-0000-03 |
First Posted: | December 6, 2016 Key Record Dates |
Last Update Posted: | March 13, 2020 |
Last Verified: | March 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Frailty Pathologic Processes |