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IRCT201111291414N29 IRCT 2012-08-14 The EMRI Endocrinology and Metabolism Research Institute ، Tehran University of Medical Sciences Investigation on autologous mesenchymal stem cell transplantation in diabetic retinopathy Investigation on autologous mesenchymal stem cell transplantation in diabetic retinopathy 2012-06-21 anticipated 20 Complete https://irct.ir/trial/680 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Prevention, Other design features: This is an interventional study to evaluate the effect autologous transplant of bone marrow stem cells for patients with diabetes type one. 0 (exploratory trials) diabetic retinopathy (dibetes type one). 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..
public
scientific Dr. Larijani
5th floor, Dr.Shariati hospital, North Kargar avenue
Tehran Iran (Islamic Republic of) 1411413137 +98 21 8822 0037 emrc@tums.ac.ir Professor Iran (Islamic Republic of) Inclusion criteria:People with diabetes type one with at least 10 years duration ;Age 18-40 years;Signing informed consent;Patients with diabetic retinopathy diagnosed by an ophthalmologist ;HbA1c ≤ 7.5% (blood glucose is controlled at least for one month);All eligible patients for celltherapy (according to standard protocol ); BP≤130/80 ;Cardiac Consultation form that is filled by a cardiologist (Cardiac echocardiography and ECG) Exclusion criteria: Acute vascular inflammation ; Acute thrombosis (three months); Pulmonary hypertension;Liver disease; Hematological malignancy and bone marrow cancer;Infectious diseases;Mental illness; Generalized edema ; Malignancy; pregnancy ; Sensitivity to the fluorescein 18 years 40 years Both H36.0* Diabetic retinopathy 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. Retin blood Flow. Timepoint: Optic Coherence Tomography(OCT), retinal artery flow (by Angiography fluorescence) and visual acuity according to the chart Snellen will be examined in our patient at regular interval : One week before, a month later, two months, six and nine months after cell treatment and visited by medical team ,and according to the protocol follow up test will be done. Method of measurement: Fluorescein Angiography. Optic Coherence. Timepoint: One week before, one, two, six and nine months after intervention. Method of measurement: Optic Coherence Tomgtaphy. The EMRI Endocrinology and Metabolism Research Institute ، Tehran University of Medical Sciences Approved 2011-12-28 Endocrine & Metabolism Research Institute Tehran University Of Medical Sciences ShariatiHospital,North KargarSt Tehran Iran (Islamic Republic of)