Effect of Intravitreal Bone Marrow Stem Cells on Ischemic Retinopathy

Not Applicable

• Conditions: Ischemia
• Interventions: Biological: Intravitreal Bone Marrow Stem Cells

• Registration Number: NCT01518842
• Lead Sponsor: University of Sao Paulo

Brief Summary

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

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2012-01-22
• Study First Submitted QC: 2012-01-25
• Study First Posted: 2012-01-26
• Status Verified: 2018-10
• Primary Completion: 2018-10
• Last Update Submitted: 2018-10-15
• Last Update Posted: 2018-10-16
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
test group intravitreal stem cell	Intravitreal Bone Marrow Stem Cells	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

Primary Outcome Measures

Name	Time	Method
Change in size of FAZ at 48 weeks	1 day to 48 weeks

Secondary Outcome Measures

Name	Time	Method
Change in central foveal thickness and best corrected visual acuity at 48 weeks	1 day to 48 weeks

Trial Locations

Locations (1)

Rubens Siqueira Research Center; 🇧🇷 Sao Jose do Rio Preto, SP, Brazil