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

Age Related Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02016508
• Other study ID #: NCT 4619792013
• Secondary ID: 4619792013
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: May 18, 2013
• Last updated: December 20, 2013
• Start date: March 2013
• Est. completion date: June 2015

Study information

• Verified date: December 2013
• Source: Al-Azhar University
• Contact: Abdelhakim mohamed safwat, M.D.
• Phone: +201005151919
• Email: abdelhakimsafwat[@]gmail.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1
• Est. completion date: June 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Age Related Macular Degeneration
• Macular Degeneration

Intervention

Drug:
• autologous bone marrow derived stem cells
intravitreal injection of autologous bone marrow stem cells in 0.1 ml volume

Locations

Country	Name	City	State
Egypt	Al-Azhar university medical school (Benin-cairo) ophthalmology department	Cairo	Nasr city

Sponsors (8)

Lead Sponsor	Collaborator
Al-Azhar University	Abou el kheir, Wael, M.D. M.Sc., Bakry, Sayed , phD. M.Sc., Gabr, Hala , M.D. M.Sc., Hassan , Hosny , M.D. M.Sc, Higazy , Hasan M.D. M.Sc, Ismail , Mahmoud M.D. M.Sc, Samour , Hany M.D. M.Sc

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Assessment of visual function changes from the base line	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	Yes