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

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ClinicalTrials.gov Identifier: NCT02016508
Recruitment Status : Unknown
Verified December 2013 by abdelhakim mohamed safwat, Al-Azhar University.
Recruitment status was:  Recruiting
First Posted : December 20, 2013
Last Update Posted : December 24, 2013
Sponsor:
Collaborators:
Hassan , Hosny , M.D. M.Sc
Samour , Hany M.D. M.Sc
Ismail , Mahmoud M.D. M.Sc
Higazy , Hasan M.D. M.Sc
Abou el kheir, Wael, M.D. M.Sc.
Gabr, Hala , M.D. M.Sc.
Bakry, Sayed , phD. M.Sc.
Information provided by (Responsible Party):
abdelhakim mohamed safwat, 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.

Condition or disease Intervention/treatment Phase
Age Related Macular Degeneration Drug: autologous bone marrow derived stem cells Phase 1 Phase 2

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intravitreal Injection of Human Bone Marrow Derived Mesenchymal Stem Cell in Patients With Dry Age-related Macular Degeneration(AMD)
Study Start Date : March 2013
Estimated Primary Completion Date : April 2015
Estimated Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: autologous bone marrow stem cells
use of autologous bone marrow derived stem cells as intravitreal injection in AMD patients
Drug: autologous bone marrow derived stem cells
intravitreal injection of autologous bone marrow stem cells in 0.1 ml volume




Primary Outcome Measures :
  1. number of subjects with adverse events [ Time Frame: 6 months ]
    Descriptive analysis of frequency and types of adverse events experienced by each subject during the study period


Secondary Outcome Measures :
  1. Assessment of visual function changes from the base line [ Time Frame: 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



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02016508


Contacts
Contact: Abdelhakim mohamed safwat, M.D. +201005151919 abdelhakimsafwat@gmail.com

Locations
Egypt
Al-Azhar university medical school (Benin-cairo) ophthalmology department Recruiting
Cairo, Nasr city, Egypt
Principal Investigator: Abdelhakim Mohamed Safwat, Msc         
Sponsors and Collaborators
Al-Azhar University
Hassan , Hosny , M.D. M.Sc
Samour , Hany M.D. M.Sc
Ismail , Mahmoud M.D. M.Sc
Higazy , Hasan M.D. M.Sc
Abou el kheir, Wael, M.D. M.Sc.
Gabr, Hala , M.D. M.Sc.
Bakry, Sayed , phD. M.Sc.

Responsible Party: abdelhakim mohamed safwat, assistant lecturer ophthalmology department al-azhar university, Al-Azhar University
ClinicalTrials.gov Identifier: NCT02016508     History of Changes
Other Study ID Numbers: NCT 4619792013
4619792013 ( Other Grant/Funding Number: Al-Azhar university )
First Posted: December 20, 2013    Key Record Dates
Last Update Posted: December 24, 2013
Last Verified: December 2013

Keywords provided by abdelhakim mohamed safwat, Al-Azhar University:
Adult bone marrow stem cells
AMD

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases