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

NCT02675556 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2019-04-01

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Joshua M Hare

    lead OTHER

Principal Investigators

  • Joshua M Hare, MD · ISCI / University of Miami Miller School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-31
Primary Completion
2019-03-26
Completion
2019-03-26
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02675556 on ClinicalTrials.gov