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Investigation on autologous mesenchymal stem cell transplantation in diabetic retinopathy

Investigation on autologous mesenchymal stem cell transplantation in diabetic retinopathy

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT201111291414N29
Enrollment
20
Registered
2012-08-14
Start date
2012-06-21
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetic retinopathy (dibetes type one). Diabetic retinopathy

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

The EMRI Endocrinology and Metabolism Research Institute ? Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Optic Coherence. Timepoint: One week before, one, two, six and nine months after intervention. Method of measurement: Optic Coherence Tomgtaphy.

Countries

Iran (Islamic Republic of)

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026