Trial | NCT01518842  Report issue

Official Title

Effect of Intravitreal Bone Marrow Stem Cells on Ischemic Retinopathy

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    30
This study aims to evaluate the behavior of the intravitreal use of bone marrow derived stem cells in patients with ischemic retinopathy.
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.
Study Started
Sep 30
2011
Primary Completion
Oct 31
2018
Study Completion
Jan 31
2020
Anticipated
Last Update
Oct 16
2018

Biological 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.

test group intravitreal stem cell Experimental

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

Criteria 

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
No Results Posted