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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.

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