Last updated on September 2018

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


Brief description of study

Before initiating the full randomized study, a Pilot Safety Phase will be performed. The randomized portion of this trial will be conducted after a full review of the safety data from the Pilot Phase by the Data safety monitoring board.

Following the Pilot Phase of fifteen (15) subjects, up to thirty (30) subjects are scheduled to undergo infusion and meeting all inclusion/exclusion criteria will be evaluate at baseline.

An additional twenty (20) subjects will be enrolled in a safety trial for antibiotic free cells.

Detailed Study Description

A Pilot Phase will be performed to test the safety of dose and volume escalation of cells administered via peripheral intravenous infusion. The randomized portion of the study will be conducted after a full review of the safety data from the Pilot Phase by the data safety monitoring board.

PILOT STUDY At the pilot subjects one year phone call visit, all fifteen (15) pilot subjects will be provided with the option of having up to four additional infusions of allogeneic hMSCs.

RANDOMIZATION STUDY This Phase I/II, randomized, blinded, placebo-controlled study is designed to evaluate the safety and tolerability of allogenic human mesenchymal stem cells in patients with Frailty and to explore potential efficacy over 4 weeks. Subjects that receive placebo in the randomized phase may be eligible to receive a dose of stem cells (allo--hMSCs).

Approximately fifteen (15) subjects will be enrolled in the pilot phase and thirty (30) subjects will be enrolled in the randomized phase with Frailty will be enrolled. Subjects will then be enrolled and randomized 1:1:1 to an active arm or placebo. If a subject received placebo, in the randomized phase they may be eligible / have the option to receive one infusion of allogeneic hMSCs.

An additional twenty (20) subjects will be enrolled in a safety trial for antibiotic free cells.

Eligible subjects must have a diagnosis or symptoms of frailty as defined by the Canadian Study on Health & Aging. Following informed consent before or at the screening visit, the diagnosis of FRAILTY will be confirmed by investigator review of medical history.

Clinical Study Identifier: NCT02065245

Contact Investigators or Research Sites near you

Start Over

Joshua M Hare, MD

ISCI/University of Miami Miller School of Medicine
Miami, FL United States

Recruitment Status: Closed


Brief Description Eligibility Contact Research Team


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