Cellular Therapy for Type 1 Diabetes Using Mesenchymal Stem Cells (NCT04061746) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Cellular Therapy for Type 1 Diabetes Using Mesenchymal Stem Cells
United States60 participantsStarted 2020-02-27
Plain-language 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.
Who can participate
Age range18 Years – 40 Years
SexALL
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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…
What they're measuring
1
12 month Change in C-peptide area under the curve after a 2-hour MMTT
Timeframe: 1 year (plus or minus 30 days) after infusion