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Allogeneic Mesenchymal Human Stem Cells Infusion Therapy for Endothelial DySfunctiOn in Diabetic Subjects

NCT02886884 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2022-05-11

Study results available
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Summary

This is a 16 subject trial to demonstrate the safety of allogeneic hMSCs administered via infusion therapy for diabetic subjects with endothelial dysfunction.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

20 million Allogeneic Mesenchymal Human Stem Cells

1 single intravenous infusion

DRUG

100 million Allogeneic Mesenchymal Human Stem Cells

1 single intravenous infusion

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • 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
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-20
Primary Completion
2019-08-26
Completion
2020-09-03
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT02886884 on ClinicalTrials.gov