Safety Study of Use of Autologous Bone Marrow Derived Stem Cell in Treatment of Age Related Macular Degeneration
Intravitreal Injection of Human Bone Marrow Derived Mesenchymal Stem Cell in Patients With Dry Age-related Macular Degeneration(AMD)
2 other identifiers
interventional
1
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Mar 2013
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 18, 2013
CompletedFirst Posted
Study publicly available on registry
December 20, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedDecember 24, 2013
December 1, 2013
2.1 years
May 18, 2013
December 20, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
number of subjects with adverse events
Descriptive analysis of frequency and types of adverse events experienced by each subject during the study period
6 months
Secondary Outcomes (1)
Assessment of visual function changes from the base line
6 months
Study Arms (1)
autologous bone marrow stem cells
EXPERIMENTALuse of autologous bone marrow derived stem cells as intravitreal injection in AMD patients
Interventions
intravitreal injection of autologous bone marrow stem cells in 0.1 ml volume
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Al-Azhar Universitylead
- Hassan , Hosny , M.D. M.Sccollaborator
- Samour , Hany M.D. M.Sccollaborator
- Ismail , Mahmoud M.D. M.Sccollaborator
- Higazy , Hasan M.D. M.Sccollaborator
- Abou el kheir, Wael, M.D. M.Sc.collaborator
- Gabr, Hala , M.D. M.Sc.collaborator
- Bakry, Sayed , phD. M.Sc.collaborator
Study Sites (1)
Al-Azhar university medical school (Benin-cairo) ophthalmology department
Cairo, Nasr City, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant lecturer ophthalmology department al-azhar university
Study Record Dates
First Submitted
May 18, 2013
First Posted
December 20, 2013
Study Start
March 1, 2013
Primary Completion
April 1, 2015
Study Completion
June 1, 2015
Last Updated
December 24, 2013
Record last verified: 2013-12