The safety of placental mesenchymal stem cell therapy for the treatment of type 1 diabetes mellitus
Phase 1
Recruiting
- Conditions
- Diabetes Mellitus type 1.Type 1 diabetes mellitus without complicationsE10.9
- Registration Number
- IRCT20171021036903N2
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
both gender
12-18 years old
type one diabetes mellitus
at least one positive auto antibody of T1DM
in first 6 month of diagnosis
Exclusion Criteria
malignancy
simultaneous auto immune disorders
pregnancy
chronic disorder other than diabetes
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Daily insulin requirement. Timepoint: Before intervention and 1,3,6,12 month after intervention. Method of measurement: daily insulin requirement per kilogram weight.;HbA1c. Timepoint: Before and 1,3,6,12 month after intervention. Method of measurement: blood sample.;C peptide level. Timepoint: Before and 1,3,6,12 month after intervention. Method of measurement: blood sample.
- Secondary Outcome Measures
Name Time Method ife threatening major side effect. Timepoint: before and 1,3,6 ,12 months after intervention. Method of measurement: physical examination.