Ischemia
Conditions
Keywords
ischemic retinopathy, stem cell,bone marrow
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.
Interventions
BIOLOGICALIntravitreal Bone Marrow Stem Cells
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.
Sponsors
University of Sao Paulo
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
intravitreal injection of autologous bone marrow stem cells
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in size of FAZ at 48 weeks | 1 day to 48 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change in central foveal thickness and best corrected visual acuity at 48 weeks | 1 day to 48 weeks |
Countries
Brazil
Outcome results
None listed