Effect of Intravitreal Bone Marrow Stem Cells on Ischemic Retinopathy
NCT ID: NCT01518842
Last Updated: 2018-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2011-09-30
2020-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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test group intravitreal stem cell
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
Intravitreal 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.
Interventions
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Intravitreal 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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University of Sao Paulo
OTHER
Responsible Party
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Rubens Camargo Siqueira
MD,PhD - Principal Investigator
Principal Investigators
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Rubens C Siqueira, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Rubens Siqueira Research Center
Locations
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Rubens Siqueira Research Center
São José do Rio Preto, São Paulo, Brazil
Countries
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References
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Siqueira RC, Messias A, Gurgel VP, Simoes BP, Scott IU, Jorge R. Improvement of ischaemic macular oedema after intravitreal injection of autologous bone marrow-derived haematopoietic stem cells. Acta Ophthalmol. 2015 Mar;93(2):e174-6. doi: 10.1111/aos.12473. Epub 2014 Jun 22. No abstract available.
Other Identifiers
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Siqueira Research Center
Identifier Type: -
Identifier Source: org_study_id
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