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

December 20, 2013 updated by: abdelhakim mohamed safwat, Al-Azhar University

Intravitreal Injection of Human Bone Marrow Derived Mesenchymal Stem Cell in Patients With Dry Age-related Macular Degeneration(AMD)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

1

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Nasr city
      • Cairo, Nasr city, Egypt
        • Recruiting
        • Al-Azhar university medical school (Benin-cairo) ophthalmology department
        • Principal Investigator:
          • Abdelhakim Mohamed Safwat, Msc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Azhar University

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Anticipated)

April 1, 2015

Study Completion (Anticipated)

June 1, 2015

Study Registration Dates

First Submitted

May 18, 2013

First Submitted That Met QC Criteria

December 16, 2013

First Posted (Estimate)

December 20, 2013

Study Record Updates

Last Update Posted (Estimate)

December 24, 2013

Last Update Submitted That Met QC Criteria

December 20, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCT 4619792013
  • 4619792013 (Other Grant/Funding Number: Al-Azhar university)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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