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

Phase 1

• Conditions: Age Related Macular Degeneration
• Interventions: Drug: autologous bone marrow derived stem cells

• Registration Number: NCT02016508
• Lead Sponsor: Al-Azhar University

Brief 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.

Detailed Description

This study is an open-label investigation of the safety and preliminary efficacy of unilateral intravitreal injection of autologous bone marrow stem cells in subjects with Geographic Atrophy secondary to Age-Related Macular Degeneration (AMD). Subjects will be enrolled based on specific inclusion/exclusion criteria and evaluated at regular post transplant intervals.

Human central nervous system -stem cells will be transplanted by a vitreoretinal surgeon. The transplantation will be conducted in the eye with the inferior best-corrected visual acuity (BCVA) (i.e., the Study Eye). Only the Study Eye will undergo transplantation. The adult bone marrow stem cells will be administered into the vitreous cavity through a standard surgical approach.

Moxifloxacin 300 mg(once per day ) will be administered orally to all subjects for a period of five days ( 2 days pre and post operatively) .

Subjects will be monitored frequently for a total of one year after adult bone marrow stem cells cell injection .

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-05-18
• Status Verified: 2013-12
• Study First Submitted QC: 2013-12-16
• Study First Posted: 2013-12-20
• Last Update Submitted: 2013-12-20
• Last Update Posted: 2013-12-24
• Primary Completion: 2015-04
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
autologous bone marrow stem cells	autologous bone marrow derived stem cells	use of autologous bone marrow derived stem cells as intravitreal injection in AMD patients

Primary Outcome Measures

Name	Time	Method
number of subjects with adverse events	6 months	Descriptive analysis of frequency and types of adverse events experienced by each subject during the study period

Secondary Outcome Measures

Name	Time	Method
Assessment of visual function changes from the base line	6 months	assessment will include Change in the mean of BCVA, Optical Coherence Tomography imaging, fluorescein angiography, slitlamp examination with fundus photography, Electroretinographic evidence (mfERG) showing enhanced activity in the location

Trial Locations

Locations (1)

Al-Azhar university medical school (Benin-cairo) ophthalmology department; 🇪🇬 Cairo, Nasr city, Egypt