Investigation on autologous mesenchymal stem cell transplantation in diabetic nephrophaty (type one)
Early Phase 1
- Conditions
- Diabetes Nephropathy (type 1).Glomerular disorders in diabetes mellitus
- Registration Number
- IRCT201111291414N28
- Lead Sponsor
- Endocrinology and Metabolism Research Institute (EMRI)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
1.signing informed consent
2.People with diabetes type one with at least 10 years duration
3.age 18-40 years
4.Diabetic nephropathy diagnosed by nephrologists
5.HbA1c = 7.5% (blood glucose is controlled at least for one month)
Exclusion criteria:
1.acute vascular inflammation
2.acute thrombosis (three months)
3. recent bleeding in the retina (the last three months)
4. pulmonary hypertension
5. liver disease
6. tumors in bone marrow or any malignancy is diagnosed
7.infectious diseases
8.mental illness
9. generalized edema
10. malignancy
11.pregnancy
12.Diastolic blood pressure =110
13. Cigar Smoker
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method GFR. Timepoint: Before intervention(time 0) and 4,12,24,48,96 weeks after cell infusion. Method of measurement: using MDRD and Cockroft-Gault formula-ml/min/1.73square meter.;Albumin/Creatinine ratio. Timepoint: Before intervention(time 0) and 4,12,24,48,96 weeks after cell infusion. Method of measurement: mg/mmol.
- Secondary Outcome Measures
Name Time Method C-peptide. Timepoint: Before intervention(time 0) and 4,12,24,48,96 weeks after cell infusion. Method of measurement: ng/ml.;Cr. Timepoint: Before intervention(time 0) and 4,12,24,48,96 weeks after cell infusion. Method of measurement: mg/dl.;BUN. Timepoint: Before intervention(time 0) and 4,12,24,48,96 weeks after cell infusion. Method of measurement: mg/dl.;HbA1c. Timepoint: Before intervention(time 0) and 4,12,24,48,96 weeks after cell infusion. Method of measurement: %.;FBS. Timepoint: Before intervention(time 0) and 4,12,24,48,96 weeks after cell infusion. Method of measurement: mg/dl.