Cellular Therapy for Type 1 Diabetes Using Mesenchymal Stem Cells

Description

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

Study Overview

Study Details

Study overview

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.

Cellular Therapy for Type 1 Diabetes Using Mesenchymal Stem Cells

Cellular Therapy for Type 1 Diabetes Using Mesenchymal Stem Cells

Condition
Diabetes Mellitus, Type 1
Intervention / Treatment

-

Contacts and Locations

Charleston

Medical University of South Carolina, Charleston, South Carolina, United States, 29425

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * A new diagnosis of T1D based on the ADA criteria within 6 months of randomization.
  • * Male and female between the ages of 18 and 30
  • * Mentally stable and able to comply with the procedures of the study protocol
  • * Positivity for at least one T1D-associated autoantibody, such as GAD, IA-2 or ZnT8 autoantibodies
  • * At screening, patients must have residual β cell function with a stimulated peak C-peptide \>0.2 nmol/l during a 2 hour MMTT
  • * Must be willing to comply with "intensive diabetes management" (\* See diabetes management at MUSC below) as directed by the participant's clinician with the goal of maintaining blood glucose as close to normal as possible
  • * Subject must be willing to comply with the schedule of study visits and protocol requirements
  • * Subject with normal laboratory values of: White blood cell counts: between 4,500 to 11,000 per microliter; Platelet counts: 140,000 to 450,000 platelets per microliter of blood; Serum creatinine range is 0.6-1.3 mg/dL, Hepatic function: ALT 5 to 55 units per liter (U/L), AST 5 to 48 U/L.
  • * Evidence of retinopathy at baseline based on ophthalmologic examination or medical record review.
  • * Body Mass Index \< 14 or \>35
  • * Presence of malignancy
  • * Subject has abnormally high lipid levels that exceeds \> 3 times the upper limit of normal for LDL cholesterol or triglycerides
  • * Subject has blood pressure greater than 160 mmHg systolic or 100 mmHg diastolic at time of consent
  • * Subject is being treated for severe active infection of any type
  • * A female subject who is breast-feeding, pregnant, or intends to become pregnant during the study.
  • * Subject with clinically relevant uncontrolled medical condition not associated with diabetes (e.g. severe psychiatric, hematologic, renal, hepatic, neurologic, cardiac, or respiratory disorder)
  • * Subjects with HgbA1c \>12%, and/or fasting blood glucose \>270 mg/dL and/or frequent episodes of hypoglycemia (\>2 episodes per week of blood glucose levels \<60 mg/dL).

Ages Eligible for Study

18 Years to 30 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Medical University of South Carolina,

Hongjun Wang, PhD, PRINCIPAL_INVESTIGATOR, Medical University of South Carolina

Study Record Dates

2026-03-31