Investigation on autologous mesenchymal stem cell transplantation in diabetic retinopathy
Early Phase 1
- Conditions
- diabetic retinopathy (dibetes type one).Diabetic retinopathyH36.0*
- Registration Number
- IRCT201111291414N29
- Lead Sponsor
- The EMRI Endocrinology and Metabolism Research Institute ? Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 20
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
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Optic Coherence. Timepoint: One week before, one, two, six and nine months after intervention. Method of measurement: Optic Coherence Tomgtaphy.