This study is intended to evaluate the safety and potential efficacy of Allogeneic Human Mesenchymal Stem Cell Infusion versus placebo in patients with Treatment Resistant Depression.
This is a phase I study, with eight subjects in the pilot phase and eighty (80) subjects fulfilling all inclusion/exclusion criteria's will be randomly assigned to receive allogeneic Human Mesenchymal Stem Cell (hMSCs) or placebo in a 1:1 blinded fashion. The 8 subjects in the pilot phase will receive a single infusion of 100 million hMSCs. 40 patients will receive a single administration of allogeneic hMSCs and another 40 patients will receive a single administration of Placebo in a 1:1 blinded fashion. Following infusion, patients will be followed at 2, 4, 6, 8, 10 and 12 week's post-infusion to complete all safety and efficacy assessments. During these 12 weeks starting after the week 2 visit subjects will have a phone call in-between their visits. Patients will additionally be followed for up to 12 months post-infusion.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
1
a single administration of allogeneic Human Mesenchymal Stem Cell (hMSCs): 100 x 10\^6 (100 million) allo-hMSCs of cells
a placebo administration consisting of 1% human albumin serum in Plasma-Lyte A
University of Miami Miller School of Medicine
Miami, Florida, United States
Incidence of any treatment-emergent serious adverse events (TE-SAEs)
defined as a composite of acute suicidality, and hospitalization for suicide attempts.
Time frame: One month post infusion
Reduction of Inflammation
Reduction of Inflammation: Change in serum concentrations of high sensitivity C-Reactive Protein (hs-CRP)
Time frame: Week 12
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