NCT02675556

Allogeneic Human Mesenchymal Stem Cells (hMSCs) Infusion in Patients With Treatment Resistant Depression

A Phase I, Prospective, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Potential Efficacy of Allogeneic Human Mesenchymal Stem Cell Infusion Versus Placebo in Patients With Treatment Resistant Depression.

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Joshua M Hare · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Treatment Resistant Depression

Interventions

Type	Name	Description
DRUG	Allo-hMSCs	a single administration of allogeneic Human Mesenchymal Stem Cell (hMSCs): 100 x 10\^6 (100 million) allo-hMSCs of cells
DRUG	Placebo	a placebo administration consisting of 1% human albumin serum in Plasma-Lyte A

Timeline

• Start date: 2017-10-31
• Primary completion: 2019-03-26
• Completion: 2019-03-26
• First posted: 2016-02-05
• Last updated: 2019-04-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study