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Infusion of Umbilical Cord Versus Bone Marrow Derived Mesenchymal Stem Cells to Evaluate Cytokine Suppression.

NCT03059355 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2022-11-08

Study results available
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Summary

This study is to compare the safety and efficacy of UCMSCs and BMMSCs administered intravenously in patients to evaluate cytokine suppression in patients with chronic inflammation. Cells administered via intravenous infusion (IV) and will be tested in 37 patients in two phases (Pilot and Randomized).

Conditions

Interventions

BIOLOGICAL

UCMSCs

Allogeneic Umbilical Cord Tissue derived MSCs (UCMSCs)

BIOLOGICAL

BMMSCs

Bone Marrow derived Mesenchymal Stem Cells (BMMSCs)

OTHER

Placebo

a single administration of placebo delivered via peripheral intravenous infusion.

Sponsors & Collaborators

  • The Marcus Foundation

    collaborator OTHER

  • 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
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-12
Primary Completion
2020-03-23
Completion
2021-02-11
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT03059355 on ClinicalTrials.gov