A Pilot, Randomized Sham Control Trial of Autologous Bone Marrow Derived Mononuclear Cells in Acute Ischemic Central Retinal Vein Occlusion.

ABSTRACT

In this pilot, sham controlled randomized control trial (RCT) in patients with ischemic central retinal vein occlusion (CRVO), we studied the safety and efficacy of intravitreal injection of autologous bone marrow derived mononuclear cells and found that both patients who received stem cell injections did not develop anterior segment neovascularization at 1 year follow up. Except for some sterile inflammatory reaction in the initial follow up, no long term injection related serious adverse events (SAEs) were observed. Based on our observations we recommend a larger, multicentric study to further establish the safety and efficacy of this treatment in patients with ischemic CRVO. Purpose: To study the safety and efficacy of autologous bone marrow derived mononuclear cells injected intravitreally in patients with ischemic CRVO. Study Design: Randomized sham controlled trial. Methods: 4 cases with ischemic CRVO were recruited into the study. 2 cases were randomized into intervention group and 2 into control group. Baseline investigations included best corrected visual acuity (BCVA), intra ocular pressure (IOP), fundus fluorescein angiography (FFA), gonioscopy and optical coherence tomography (OCT). Patients in the intervention group received intravitreal injection of autologous bone marrow derived mononuclear cells (MNCs) and those in control group received sham injection. Patients were followed up over a 12-month period. Main Outcome Measures: Development of anterior segment neovascularization. Results: Both patients in the intervention group did not develop anterior segment neovascularization over a follow up period of 12 months. 1 patient in control group developed neovascularization of iris and elevated intra ocular pressure over a follow up period of 6 weeks and required trabeculectomy for control of IOP. The other patient in control group was lost follow up after 2 weeks. Conclusions: Our initial observations suggest that intravitreal injection of mononuclear cells may reduce the risk of developing anterior segment neovascularization in patients with ischemic central retinal vein occlusion. A larger, multicentric study would be valuable to gain further evidence to our preliminary observations.