Diabetic neurophaty. Diabetic polyneuropathy (E10-E14 with common fourth character .4+)
Conditions
Interventions
Once Injection 2 million cells per kilogram of body weight of autologous mesenchymal stem cells were taken from the bone marrow amount of 50 ml during 30 minutes for one time..
Treatment - Other
Once Injection 2 million cells per kilogram of body weight of autologous mesenchymal stem cells were taken from the bone marrow amount of 50 ml during 30 minutes for one time.
Sponsors
???Endocrinology & Metabolism Research Institute Tehran University Of Medical Sciences
Eligibility
Sex/Gender
All
Age
40 Years to 60 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Outcome results
None listed