Type 1 diabetes mellitus (T1DM). Type 1 diabetes mellitus
Conditions
Interventions
Intervention 1: Intervention group-1: In this group, patients will be given allogeneic adipose tissue derived MSCs (single intravenous [IV] infusion of 1×10^6 cells/kg suspended in 100 mL of normal sa
Sponsors
Endocrinology and Metabolism Research Institute
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: All adults (= 18 year) with T1DM which diagnosis less than 1 year from the onset of diabetes Have at least one T1DM related autoantibody
Exclusion criteria
Exclusion criteria: Inability to fill informed consent Pregnancy in women Having any chronic complication of diabetes including nephropathy, retinopathy and vascular complications Having a serious infection or have a positive test for hepatitis B, hepatitis C or HIV Having other chronic comorbidities such as psychological, cardiovascular, renal, pulmonary, liver, hematologic and other serious autoimmune diseases (except T1DM or Hashimoto's disease) History of cancer History of diabetic ketoacidosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Daily insulin requirement. Timepoint: Before intervention and 1, 2, 3, 4, 8, 12, 24, 36, 48 weeks after intervention. Method of measurement: Total daily Insulin Requirement (in units of insulin).;HbA1c. Timepoint: Before intervention and 1, 3, 6, 9, 12 month after intervention. Method of measurement: Blood sample.;Basal and stimulated C-peptide level. Timepoint: Before intervention and 1, 3, 6, 9, 12 month after intervention. Method of measurement: Blood sample. | — |
Secondary
| Measure | Time frame |
|---|---|
| Side effects. Timepoint: Before intervention and 1, 2, 3, 4, 8, 12, 24, 36, 48 weeks after intervention. Method of measurement: History and physical examination. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSayed Mahmoud Sajjadi Jazi
Tehran University of Medical Sciences
Outcome results
None listed