Cellular Therapy for Type 1 Diabetes Using Mesenchymal Stem Cells

Trial ID: NCT04061746

Interventional - Phase 1 - Active, not recruiting

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

Interventions

• Mesenchymal Stem Cells (MSCs)
• Placebo Infusion (Plasmalyte A with 0.5% human serum albumin)

Eligibility

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).

Sponsor

Medical University of South Carolina, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Source: ClinicalTrials.gov

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