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

  • STATUS
    Recruiting
  • days left to enroll
    66
  • participants needed
    83
  • sponsor
    Longeveron LLC
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Updated on 24 January 2021
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Summary

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.

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.

Details
Condition Aging Frailty
Treatment Longeveron Mesenchymal Stem Cells (LMSCs), Fluzone High Dose Vaccine
Clinical Study IdentifierNCT02982915
SponsorLongeveron LLC
Last Modified on24 January 2021

Eligibility

 Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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