Type 1 diabetes mellitus. Type 1 diabetes mellitus
Conditions
Interventions
Intervention 1: Intervention group: Receipt of a single intravenous infusion of allogeneic placenta-derived mesenchymal stem cells at a dose of 1×106 cells/kg body weight, in addition to standard insu
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Diagnosis of Type 1 Diabetes according to the American Diabetes Association (ADA) criteria, with confirmation of autoimmune destruction of pancreatic beta cells (positive for at least one autoantibody: GAD65, IA-2, or ZnT8). Disease duration of less than one year (12 months) from diagnosis. Age 18 years or older. Absence of chronic, debilitating diseases such as cancer, kidney failure, or active autoimmune diseases. No active infections, including HIV, Hepatitis B/C, or severe bacterial diseases. No long-term use of immunosuppressive drugs or steroids in the past 3 months. Agreement to participate in the study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: Diagnosis of Type 2 Diabetes or Latent Autoimmune Diabetes in Adults (LADA). Multiple organ failure, including: kidney failure (eGFR < 60 ml/min/1.73m²), heart failure (EF < 40%), or severe liver failure. Severe active autoimmune diseases such as Systemic Lupus Erythematosus (SLE), severe Rheumatoid Arthritis, or active Multiple Sclerosis (MS). History of transplant rejection or severe allergic reaction to cellular products. Pregnancy or breastfeeding in women. History of cancer in the past 5 years. History of thrombosis, stroke, or severe cardiac events in the past 6 months. Addiction to alcohol or illicit drugs. Patient non-cooperation or inability to adhere to study follow-up appointments.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events related to allogeneic MSCs transplantation. Timepoint: Assessment of any acute adverse events within the first 24 hours, subacute events within the first week, and delayed adverse events at months 1, 3, 6, 9, and 12 post-cell transplantation.thumb_upthumb_down. Method of measurement: Adverse events will be documented through patient interviews, clinical examinations, and laboratory tests. The severity of events will be assessed and graded according to the latest version of the “Common Terminology Criteria for Adverse Events (CTCAE)” standard. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in C-peptide area under the curve after a 2-hour MMTT. Timepoint: Measured at baseline and at months 6 and 12. Method of measurement: Serum C-peptide levels are measured at specified time points (0, 30, 60, 90, and 120 minutes) during a standardized Mixed-Meal Tolerance Test (MMTT) using immunoassay methods (such as ECLIA). Subsequently, the Area Under the Curve (AUC) is calculated. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactHamid Reza Aghayan
Tehran University of Medical Sciences
Outcome results
None listed