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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 complications
E10.9
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
NameTimeMethod
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
NameTimeMethod
ife threatening major side effect. Timepoint: before and 1,3,6 ,12 months after intervention. Method of measurement: physical examination.
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