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Human Mesenchymal Stem Cells (LMSCs) on Vaccine-Specific Antibody- Response in Subjects With Aging Frailty (HERA)

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by Longeveron LLC
Sponsor:
Information provided by (Responsible Party):
Longeveron LLC
ClinicalTrials.gov Identifier:
NCT02982915
First received: November 17, 2016
Last updated: May 23, 2017
Last verified: May 2017
  Purpose
This is a phase I/II, randomized, blinded and placebo-controlled study to test the safety and efficacy of LMCSs for improving vaccine immune response.

Condition Intervention Phase
Aging Frailty Biological: Longeveron Mesenchymal Stem Cells (LMSCs) Biological: Fluzone High Dose Vaccine Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Further study details as provided by Longeveron LLC:

Primary Outcome Measures:
  • 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' judgment.

  • Changes from baseline through month 12 in adaptive immunity and primary B cell response to the influenza vaccine in subjects with Aging Frailty. [ Time Frame: Week 1 and Week 4 post vaccination, month 6 and month 12 post infusion follow up ]

Secondary Outcome Measures:
  • Post-vaccination changes from baseline in the influenza specific plasmablast differential between the LMSC and Placebo Cohorts [ Time Frame: At 1 week and 4 weeks post vaccination ]
    • Prevention of the illness caused by any influenza viral type/subtype in association with influenza like symptoms (e.g., 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 biomarkers [ Time Frame: Month 6 and month 12 post infusion ]
  • Differences in rate of decline from Aging Frailty [ Time Frame: Baseline, Month 6 and month 12 post infusion ]
  • Changes in subject quality of life (QOL) [ Time Frame: Baseline, Month 6 and month 12 post infusion ]
  • Death from any cause [ Time Frame: Month 6 and month 12 post infusion ]

Estimated Enrollment: 43
Study Start Date: November 2016
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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: 10 subjects) or placebo (Cohort B: 10 subjects) followed by vaccination with Fluzone High-Dose.
Biological: Longeveron Mesenchymal Stem Cells (LMSCs)
Intravenously delivered
Biological: Fluzone High Dose Vaccine
Intramuscular injection

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 LMSCs. This will be followed by a double-blinded, randomized, placebo-controlled phase.
  Eligibility

Ages Eligible for Study:   65 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • be willing and able to provide written informed consent and comply with all procedures required by the protocol.
  • be 65 - 85 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 serum tumor necrosis factor levels (TNF-α) ≥ 2.5 pg/mL.
  • 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 >8.0%.
  • 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 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 verimic 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 transplant).
  • be actively listed (or expected to be listed) for transplant of any organ (other than corneal 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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02982915

Contacts
Contact: Suzanne Page, JD (305) 342-9590 spage@longeveron.com
Contact: Ann Glasse, RN, BSN, MBA (305) 909-0843 aglasse@longeveron.com

Locations
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Russell Saltzman    305-243-1152    r.saltzman@med.miami.edu   
Principal Investigator: Dushyantha T. Jayaweera, MD         
Vista Health Research Recruiting
Miami, Florida, United States, 33176
Contact: Jessica Palacio, MHA/ED, CCRC    305-271-7660    jpalacio@vista-health.org   
Principal Investigator: Antonio Blanco, MD         
Sponsors and Collaborators
Longeveron LLC
Investigators
Principal Investigator: Dushyantha T Jayaweera, MD University of Miami
  More Information

Responsible Party: Longeveron LLC
ClinicalTrials.gov Identifier: NCT02982915     History of Changes
Other Study ID Numbers: 00-0000-03
Study First Received: November 17, 2016
Last Updated: May 23, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Vaccines
Antibodies
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 21, 2017