AllogeneiC Human Mesenchymal Stem Cells (hMSC) in Patients With Aging FRAilTy Via IntravenoUS Delivery

Phase 2CompletedNCT02065245

Longeveron Inc.65 enrolled

Overview

The purpose of this study is to look at the safety of treatment with stem cells in patients with Frailty.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Frailty

Interventions

Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs)BIOLOGICAL

Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion

PlaceboBIOLOGICAL

Placebo administered by peripheral intravenous infusion.

Penicillin/Streptomycin-Free Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs)BIOLOGICAL

Penicillin/Streptomycin-Free Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion.

Eligibility

Sex: ALLMin age: 60 YearsMax age: 95 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Provide written informed consent. * Subjects age greater than or equal to 60 and less than or equal to 95 years at the time of signing the Informed Consent Form. * Show signs of frailty apart from a concomitant condition as assessed by the Investigator with a frailty score of 4 to 7 using the Clinical Frailty Scale * Female subjects with an Follicle-stimulating hormone (FSH) equal to or \> 25.8 milli-international units (mIU) /mL (milliliter), if not currently on hormone replacement therapy. Exclusion Criteria: * Score of less than or equal to 24 on the Mini Mental State Examination (MMSE) * Inability to perform any of the assessments required for endpoint analysis (report safety or tolerability concerns, perform pulmonary function tests, undergo blood draws, read and respond to questionnaires. * Active listing (or expected future listing) for transplant of any organ. * Clinically important abnormal screening laboratory values, including but not limited to: hemoglobin \<8 g/dl, white blood cell count \<3000/mm3, platelets\<80,000/mm3, international normalized ratio (INR) \> 1.5 not due to a reversible cause (i.e. Coumadin), aspartate transaminase, alanine transaminase, or alkaline phosphatase \> 3 times upper limit of normal, total bilirubin \> 1.5 mg/dl. * Serious comorbid illness that, in the opinion of the investigator, may compromise the safety or compliance of the patient or preclude successful completion of the study. Including, but not limited to: HIV, advanced liver or renal failure, class III/IV congestive heart failure, myocardial infarction, unstable angina, or cardiac revascularization within the last six months, or severe obstructive ventilatory defect. * Any other condition that, in the opinion of the investigator, may compromise the safety or compliance of the patient or preclude successful completion of the study. * Be an organ transplant recipient. * Have a clinical history of malignancy within 5 years (i.e., patients with prior malignancy must be disease free for 5 years), except curatively-treated basal cell carcinoma, squamous cell carcinoma, melanoma in situ or cervical carcinoma if recurrence occurs. * Have a non-pulmonary condition that limits lifespan to \< 1 year. * Have a history of drug or alcohol abuse within the past 24 months. * Be serum positive for HIV, hepatitis B Surface Antigen (BsAg) or Viremic hepatitis C. * Be currently participating (or participated within the previous 30 days) in an investigational therapeutic or device trial. * Be a female who is pregnant, nursing, or of childbearing potential while not practicing effective contraceptive methods. Female patients must undergo a blood or urine pregnancy test at screening and within 36 hours prior to infusion. * Have hypersensitivity to dimethyl sulfoxide (DMSO)

Locations (1)

ISCI/University of Miami Miller School of Medicine

Miami, Florida, United States

Outcomes

Primary Outcomes

Incidence of Any Treatment Emergent - Serious Adverse Events (TE-SAEs)

Incidence of any treatment-emergent serious adverse events (SAE), defined as the composite of: death, non-fatal pulmonary embolism, stroke, hospitalization for worsening dyspnea and clinically significant laboratory test abnormalities. * Serum chemistry: chloride, bicarbonate, blood urea nitrogen (BUN), creatinine, glucose, calcium, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin (fractionate if total \>1.5 times normal), alkaline phosphatase, albumin, * Hematology (Complete blood count): hemoglobin, hematocrit, platelets, white blood cells (WBC), WBC differential

Time frame: One Month post infusion

Secondary Outcomes

Change in Frailty as Assessed by CHAMPS Questionnaire

Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire measures duration of exercise-related activities (hours/week). The Duration variable can range from 0 - 399.75 hours per week. Higher scores indicate more activity.

Time frame: At baseline and 6 month follow-up visit.

Change in Slowing of Mobility as Measured by 4 Meter Gait Speed Test

4-meter gait speed test measures the time (in seconds) taken to walk a distance of 4 meters. The total score has a range of 1 point - 4 points with the higher score indicating faster walk speed.

Time frame: At baseline and 6 month follow-up visit.

Change in Slowing of Mobility as Measured by SPPB

Standard Physical Performance Battery (SPPB) Assessment has total score ranging from 0-4 with the higher score indicating better balance.

Time frame: At baseline and 6 month follow-up visit.

Change in Weight

Change in weight as measured in kilograms (kg).

Time frame: At baseline and 6 month follow-up visit.

Data from ClinicalTrials.gov

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