Age Related Macular DegenerationPhase 1/2NCT02016508
Safety Study of Use of Autologous Bone Marrow Derived Stem Cell in Treatment of Age Related Macular Degeneration
A Phase 1/2 study testing autologous bone marrow derived stem cells in people with Age Related Macular Degeneration, run by Al-Azhar University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age Related Macular Degeneration
- What is being tested?
- autologous bone marrow derived stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2013to Jun 2015
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Al-Azhar university medical school (Benin-cairo) ophthalmology department
Cairo, Nasr City
Abdelhakim Mohamed Safwat, Msc
About this study
Official title: 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.
Read the 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 .
- Conditions
- Age Related Macular Degeneration
- Being tested
- autologous bone marrow derived stem cells
- Keywords
- Adult bone marrow stem cells, AMD
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous bone marrow derived stem cellsDrug
intravitreal injection of autologous bone marrow stem cells in 0.1 ml volume
| Study group | Role | What they receive |
|---|---|---|
| autologous bone marrow stem cells | Experimental | use of autologous bone marrow derived stem cells as intravitreal injection in AMD patients Receives: Drug: autologous bone marrow derived stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of subjects with adverse events
Descriptive analysis of frequency and types of adverse events experienced by each subject during the study period
Measured: 6 months
Secondary outcomes (1)
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2013 (estimated)
- Study startMar 2013
- Primary completionApr 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age Related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- 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.
- Responsible party
- Principal investigator, abdelhakim mohamed safwat, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02016508
- Sponsor's protocol ID
- NCT 4619792013
- Other IDs
- 4619792013
- Status last verified
- Dec 2013
- First submitted
- 18 May 2013
- Last updated
- 24 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravitreal Injection of Human Bone Marrow Derived Mesenchymal Stem Cell in Patients With Dry Age-related Macular Degeneration(AMD)
- ClinicalTrials.gov ID
- NCT02016508
- Acronym / sponsor ID
- NCT 4619792013
- Conditions
- Age Related Macular Degeneration
- Keywords
- Adult bone marrow stem cells, AMD
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- 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 start
- Mar 2013
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 20 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| autologous bone marrow stem cells | Experimental | Drug: autologous bone marrow derived stem cellsuse of autologous bone marrow derived stem cells as intravitreal injection in AMD patients |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| autologous bone marrow derived stem cellsintravitreal injection of autologous bone marrow stem cells in 0.1 ml volume | Drug | autologous bone marrow stem cells |
Primary outcome
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
1 secondary outcome
Assessment of visual function changes from the base line
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing autologous bone marrow derived stem cells in people with Age Related Macular Degeneration, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abdelhakim mohamed safwat, M.D. (+201005151919, abdelhakimsafwat@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of subjects with adverse events (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2013.