Effect of mesenchymal stem cells transplantation to improve of diabetic neuropathy

Phase 2

• Conditions: G63.2*; Diabetic neurophaty.; Diabetic polyneuropathy (E10-E14 with common fourth character .4+)

• Registration Number: IRCT201103171414N23
• Lead Sponsor: ???Endocrinology & Metabolism Research Institute Tehran University Of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1-People with diabetes type one that their disease passed at least 10 years 2-signing informed consent, 3-age 40-60 years4- All patients are eligible for cell therapy (under protocol) 5 - HbA1c = 7.5% (blood glucose is controlled at least of one month) 6 - BP = 130/80Exclusion criteria: 1 - acute inflammation of vascular 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 - to use any walking aids 13 - having a foot ulcer during the study 14 - amputation of limbs

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Monofilament test. Timepoint: Before intervention and 6,12,24,48,96 weeks after intervention. Method of measurement: Numeration.;Diapason test. Timepoint: Before intervention and 6,12,24,48,96 weeks after intervention. Method of measurement: Numeration.;Electromyography & Nnerve conduction velocity. Timepoint: Before intervention and 6,12,24,48,96 weeks after intervention. Method of measurement: mV.;Visual Analog Scale. Timepoint: Before intervention and 6,12,24,48,96 weeks after intervention. Method of measurement: numerical.

Secondary Outcome Measures

Name	Time	Method
Weight. Timepoint: Before intervention and 4,12,24,48,96 weeks after intervention. Method of measurement: Weigher.;Fasting blood glucose. Timepoint: Before intervention and 4,12,24,48,96 weeks after intervention. Method of measurement: Glucose oxidase.;HbA1c. Timepoint: Before intervention and 4,12,24,48,96 weeks after intervention. Method of measurement: HPLC.