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Cellular Therapy for Type 1 Diabetes Using Mesenchymal Stem Cells

NCT04061746 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-04-22

No results posted yet for this study

Summary

The goal of this study is to determine the safety and efficacy of fresh metabolically active allogeneic umbilical cord-derived mesenchymal stromal cells (UC-MSCs) for the treatment of new-onset type 1 diabetes (T1D) and to understand the mechanisms of protection. If proven effective, such a strategy can be used as a therapeutic option for T1D patients and potentially other autoimmune disorders.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

BIOLOGICAL

Mesenchymal Stem Cells (MSCs)

Patients in Group A will receive a single MSCs infusion

OTHER

Placebo Infusion (Plasmalyte A with 0.5% human serum albumin)

Patients in Group B will receive a single infusion of placebo (Plasmalyte A with 0.5% human serum albumin)

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Medical University of South Carolina

    lead OTHER

Principal Investigators

  • Hongjun Wang, PhD · Medical University of South Carolina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-02-27
Primary Completion
2027-05-30
Completion
2027-05-30
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 NCT04061746 on ClinicalTrials.gov