Effect of Intravitreal Bone Marrow Stem Cells on Ischemic Retinopathy

Study Overview
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Brief Summary
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This study aims to evaluate the behavior of the intravitreal use of bone marrow derived stem cells in patients with ischemic retinopathy.

Detailed Description
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Evaluate the effects on visual acuity, electroretinography, fluorescein angiography and optical coherence tomography in 30 patients with ischemic retinopathy, including diabetic retinopathy with severe loss of retinal capillaries undergoing intravitreal injection of bone marrow derived stem cells.

Official Title
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Effect of Intravitreal Bone Marrow Stem Cells on Ischemic Retinopathy

Conditions
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Ischemia

Intervention / Treatment
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* Biological: Intravitreal Bone Marrow Stem Cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of Ischemic Retinopathy Enlargement of foveal avascular zone-FAZ (ischaemia or capillary drop out of >30% on Fluorescein retinography logarithm of minimum angle of resolution (logMAR) BCVA of 1.0 (Snellen equivalent, 20/200) or worse Able (in the Investigator's opinion) and willing to comply with all study requirements Exclusion Criteria: previous ocular surgery other than cataract presence of cataract or other media opacity that would influence ocular fundus documentation and adequate ERG and visual field evaluation other ophthalmic disease like glaucoma and uveitis previous history of blood disorders like leukemia known allergy to fluorescein or indocyanine green

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: intravitreal injection of autologous bone marrow stem cells
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: test group intravitreal stem cell<br>Open-label study of Ischemic Retinopathy patients with best-corrected visual acuity (BCVA) worse than 20/200. Intervention: Biological: intravitreal injection of autologous bone marrow stem cells | Biological: Intravitreal Bone Marrow Stem Cells<br>* One intravitreal injection of a 0.1-ml cell suspension containing around 10x106 bone marrow mononuclear stem cells(BMMSC). All treatments were performed by a single retinal specialist using topical proparacaine drops under sterile conditions (eyelid speculum and povidone-iodine). Autologous BMMSC were injected into the vitreous cavity using a 27 gauge needle inserted through the inferotemporal pars plana 3.0 - 3.5 mm posterior to the limbus. After the injection, central retinal artery perfusion was confirmed with indirect ophthalmoscopy. Patients were instructed to instill one drop of 0.3% ciprofloxacin into the injected eye four times daily for 1 week after the procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in size of FAZ at 48 weeks |  | 1 day to 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in central foveal thickness and best corrected visual acuity at 48 weeks |  | 1 day to 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ischemic retinopathy, stem cell,bone marrow