Status:
RECRUITING
Cellular Therapy for Type 1 Diabetes Using Mesenchymal Stem Cells
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18-40 years
Phase:
PHASE1
Brief 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...
Detailed Description
This study seeks to find and enroll participants between the ages of 18 to 40 with new onset Type 1 diabetes (T1D) within 6 months of the first dose of insulin. T1D is an autoimmune disease in which T...
Eligibility Criteria
Inclusion
- Inclusion 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 40
- 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.
- Exclusion criteria:
- 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).
Exclusion
Key Trial Info
Start Date :
February 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04061746
Start Date
February 27 2020
End Date
March 31 2027
Last Update
May 2 2025
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425