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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
62
Intravenously delivered
Intramuscular injection
Clinical Research of South Florida
Coral Gables, Florida, United States
Clinical Physiology Associates
Fort Myers, Florida, United States
University of Miami
Miami, Florida, United States
Vista Health Research
Miami, Florida, United States
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.
Time frame: 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.
Time frame: Baseline Visit, Vaccination Visits, Weeks 1, 2, 4, Month 6 and Month 12 Follow-Up Visits.
Changes from baseline between the LMSC and placebo cohorts as assessed by plasma cytokine levels:
Plasma levels of interleukins measured in pg/mL.
Time frame: Baseline, month 6 and month 12 after infusion
Differences in rate of decline from Aging Frailty
Change in Clinical Frailty rating
Time frame: Baseline, month 6 and month 12 after infusion
Assessed by the Falls Efficacy Scale-International and Performance Oriented Mobility Assessment
Change in risk of falling
Time frame: Baseline, month 6 and month 12 after infusion
PROMIS Short Form 20a questionnaire
Change in subject quality of life as assessed by participant-reported outcomes.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Johns Hopkins University
Baltimore, Maryland, United States
Optimal Research LLC
Rockville, Maryland, United States
Time frame: Baseline, month 6 and month 12 after infusion
PROMIS Mobility questionnaire
Change in subject quality of life as assessed by participant-reported outcomes.
Time frame: Baseline, month 6 and month 12 after infusion
PROMIS Upper Extremity questionnaire
Change in subject quality of life as assessed by participant-reported outcomes.
Time frame: Baseline, month 6 and month 12 after infusion
Short Form 36 questionnaire
Change in subject quality of life as assessed by participant-reported outcomes.
Time frame: Baseline, month 6 and month 12 after infusion
IIEF questionnaire
Change in subject quality of life as assessed by participant-reported outcomes.
Time frame: Baseline, month 6 and month 12 after infusion
SQOL-F questionnaire
Change in subject quality of life as assessed by participant-reported outcomes.
Time frame: Baseline, month 6 and month 12 after infusion
Death from any cause
Number of participants that die from any cause while enrolled on the trial and after being treated with LMSCs.
Time frame: Within 12 months after infusion
Falls Efficacy Scale-International (FES-I)
Change by participant-reported outcomes. Minimum 16 (no concern about falling) to maximum 64 (severe concern about falling)
Time frame: Baseline, month 6 and month 12 after infusion
Changes from baseline between the LMSC and placebo cohorts as assessed by B & T cell levels:
Plasma levels of B \& T Cells.
Time frame: Baseline, month 6 and month 12 after infusion
Rate of decline in Aging Frailty status as assessed by the 6 minute walk test
Distance in meters walked in 6 minutes
Time frame: Baseline, month 6 and month 12 after infusion
Rate of decline in Aging Frailty status as assessed by the Short Physical Performance Battery (SPPB)
Short Physical Performance Battery Assessment
Time frame: Baseline, month 6 and month 12 after infusion
Rate of decline in Aging Frailty status as assessed by the Tinetti POMA Test
TInetti POMA assessment
Time frame: Baseline, month 6 and month 12 after infusion
Rate of decline in Aging Frailty status as assessed by the Weight Loss
Weigh measurements at visits
Time frame: Baseline, month 6 and month 12 after infusion
Rate of decline in Aging Frailty status as assessed by the Handgrip Test
Handgrip strength via dynamometer.
Time frame: Baseline, month 6 and month 12 after infusion