Effect of Intravitreal Bone Marrow Stem Cells on Ischemic Retinopathy (RetinaCell)

University of Sao Paulo

Status: Unknown

Conditions: Ischemia

Treatments: Biological: Intravitreal Bone Marrow Stem Cells

Study type: Interventional

Funder types: Other

Identifiers

NCT01518842

Siqueira Research Center

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

test group intravitreal stem cell

Experimental group

Description:

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

Treatment:

Biological: Intravitreal Bone Marrow Stem Cells