Transplantation of stem cells for the treatment of type 1 diabetes.
Phase 1
- Conditions
- Type 1 diabetes mellitus (T1DM).Type 1 diabetes mellitus
- Registration Number
- IRCT20210925052566N1
- Lead Sponsor
- Endocrinology and Metabolism Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 30
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
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.