Safety Study of Use of Autologous Bone Marrow Derived Stem Cell in Treatment of Age Related Macular Degeneration

• Status: Unknown status
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this Phase I/II study is to investigate the safety and preliminary efficacy of unilateral intravitreally transplantation of adult bone marrow stem cells in subjects with geographic atrophy secondary to age-related macular degeneration.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Al-Azhar University
• Collaborators: Abou el kheir, Wael, M.D. M.Sc.; Bakry, Sayed , phD. M.Sc.; Gabr, Hala , M.D. M.Sc.; Hassan , Hosny , M.D. M.Sc; Higazy , Hasan M.D. M.Sc; Ismail , Mahmoud M.D. M.Sc; Samour , Hany M.D. M.Sc

Criteria

Inclusion Criteria:

• Diagnosis of age-related macular degeneration with geographic atrophy (GA)

• Only patients with a specific degree and extent of GA will be eligible

• Subjects with best-corrected visual acuity (BCVA) of less than or equal to 20/400 in the Study Eye

• No prior or current choroidal neovascularization in either eye

• Able to provide written informed consent prior to any study related procedures

• Agree to comply in good faith with all conditions of the study and to attend all required study visits

Exclusion Criteria:

• Prior vitreal or retinal surgery in the previous 6 months

• Glaucoma

• Atrophic macular disease of any other cause

• Diabetic retinopathy or diabetic macular edema in either eye

• Previous organ, tissue or bone marrow transplantation

• Autoimmune disease

• Allergy to moxifloxacin

• Current or prior malignancy (or is on chemotherapy)