RecruitingPhase 1NCT04061746

Cellular Therapy for Type 1 Diabetes Using Mesenchymal Stem Cells


Sponsor

Medical University of South Carolina

Enrollment

60 participants

Start Date

Feb 27, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a treatment using mesenchymal stem cells (special cells from the body that can influence the immune system) can help preserve insulin production in people newly diagnosed with Type 1 diabetes. In Type 1 diabetes, the immune system attacks insulin-producing cells in the pancreas; this treatment aims to slow or stop that process. **You may be eligible if...** - You have been diagnosed with Type 1 diabetes within the last 6 months - You are between 18 and 40 years old - You still have some remaining insulin production (shown by a specific blood test called C-peptide) - You have at least one diabetes-related antibody in your blood (such as GAD, IA-2, or ZnT8) - You are willing to follow an intensive diabetes management plan - You are mentally stable and able to follow the study protocol **You may NOT be eligible if...** - You have had Type 1 diabetes for more than 6 months before enrolling - You do not have measurable remaining insulin production - You are unwilling to comply with the study's management and visit schedule Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALMesenchymal Stem Cells (MSCs)

Patients in Group A will receive a single MSCs infusion

OTHERPlacebo 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)


Locations(1)

Medical University of South Carolina

Charleston, South Carolina, United States

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NCT04061746


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