Clinical trial NCT02016508: Safety Study of Use of Autologous Bone Marrow Derived Stem Cell in Treatment of Age Related Macular Degeneration
Official title: Intravitreal Injection of Human Bone Marrow Derived Mesenchymal Stem Cell in Patients With Dry Age-related Macular Degeneration(AMD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Age Related Macular Degeneration
Keywords: Adult bone marrow stem cells
AMD
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
Collaborators: name: Hassan , Hosny , M.D. M.Sc
name: Samour , Hany M.D. M.Sc
name: Ismail , Mahmoud M.D. M.Sc
name: Higazy , Hasan M.D. M.Sc
name: Abou el kheir, Wael, M.D. M.Sc.
name: Gabr, Hala , M.D. M.Sc.
name: Bakry, Sayed , phD. M.Sc.
First posted: 2013-12-20
Enrollment: 1
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 .

Eligibility 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)

Primary outcomes:
measure: number of subjects with adverse events
timeFrame: 6 months
Secondary outcomes:
measure: Assessment of visual function changes from the base line
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al-Azhar university medical school (Benin-cairo) ophthalmology department
state: Nasr city
Study officials:
References: