Age Related Macular Degeneration and StargartdAMDCELLNCT01518127
Intravitreal Bone Marrow-Derived Stem Cells in Patients With Macular Degeneration
A study testing intravitreal injection of autologous bone marrow stem cells in people with Age Related Macular Degeneration and Stargartd, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate the behavior of intravitreal injection of of autologous bone marrow stem cells in patients with age related macular degeneration. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Age Related Macular Degeneration and Stargartd
- What is being tested?
- intravitreal injection of autologous bone marrow stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2011to Dec 2015
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female AMD and Stargartd patients 18 to 80 years old, inclusive.
- In either eye, diagnosis of geographic atrophy or choroidal neovascularization due to AMD
- ETDRS best corrected visual acuity of 60 letters or worse in the study eye.
Who cannot join
- Retinal disease other than AMD in study eye which, in the investigator's opinion, may pose a safety risk or interfere with the study.
- Choroidal neovascularization due to a cause other than AMD.
- In the study eye, media opacity that interferes with fundus imaging or is likely to require surgery during the study period.
- Any of the following treatments to the study eye within 14 days prior to dosing: ranibizumab (Lucentis), bevacizumab (Avastin), pegaptanib (Macugen), or other VEGF inhibitor; OR likely requirement for one of the above treatments within 14 days of LFG316 administration.
- Any of the following within 30 days prior to dosing: photodynamic therapy treatment in the study eye; extrafoveal or juxtafoveal thermal laser photocoagulation in the study eye; systemic or topical (ophthalmic) steroid use in the study eye; bacterial keratitis in the study eye; OR intraocular surgery (including cataract surgery) in the fellow eye.
- Any of the following within 90 days prior to dosing: intraocular surgery (including cataract surgery) in the study eye; OR intravitreal or periocular corticosteroid injection in the study eye.
- Participation in another interventional clinical study, or use of any experimental treatment for AMD or any other investigational new drug within 12 weeks prior to the start of study treatment. Clinical trials solely involving over-the-counter vitamins, supplements, or diets will not exclude the patients from study participation.
- Any medical condition likely to interfere with the patient's participation in the study, or likely to cause serious adverse events during the study.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Rubens Siqueira Research Center
São José do Rio Preto, São Paulo, 15010-100
About this study
The purpose of this study is to evaluate the behavior of intravitreal injection of of autologous bone marrow stem cells in patients with age related macular degeneration.
Read the detailed description
A prospective phase I/II, nonrandomized open-label study of agen related macular degeneration and Stargartd patients with best-corrected ETDRS visual acuity (BCVA) worse than 20/200. Standardized ophthalmic evaluation will be perform at baseline and at weeks 1, 4,12 and 24 (±1) following intravitreal injection of 10 x 106 bone marrow stem cells/ 0,1ml . Three measures will be used to evaluate the short-term safety of intravitreal of bone marrow stem cells: 1) severe visual loss, defined as a drop in 15 letters on ETDRS visual acuity scale; 2) decrease in ERG response; 3) decrease in 5 square degrees on visual field; secondary safety outcomes : 1) increase in intra-ocular inflammation defined herein as anterior chamber cells and flare higher than 3+ for more than 1 month after injection according to a classification described elsewhere ; 2) decrease in CMT more than 50um; 3)genesis of abnormal tissues (teratomas) or tumors; 4) qualitative changes in retinal or choroidal perfusion, like macular nonperfusion. Secondary outcome measures will be used to evaluate the short-term efficiency of intravitreal of Bone Marrow Stem Cells: 1) improvement in ERG response; 2) increase in visual field: 3) increase in CSMT > 50um and not related to macular edemar or choroidal neovascularization; 4) increase > 5 letters on BCVA
- Being tested
- intravitreal injection of autologous bone marrow stem cells
- Keywords
- Macular Degeneration
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravitreal injection of autologous bone marrow stem cellsOther
Also called Cell Therapy
intravitreal injection of autologous bone marrow stem cells
| Study group | Role | What they receive |
|---|---|---|
| stem cell group | Experimental | intravitreal injection of autologous bone marrow stem cells Receives: Other: intravitreal injection of autologous bone marrow stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
ETDRS Visual acuity change
Primary safety outcome included visual acuity loss of 15 or more ETDRS letters after treatment
Measured: Day 1 to Day 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2012 (estimated)
- Study startAug 2011
- Primary completionSep 2013
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age Related Macular Degeneration and StargartdStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- intravitreal injection of autologous bone marrow stem cells
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rubens Camargo Siqueira, University of Sao Paulo
- Investigators
- Rubens C Siqueira, MD,PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01518127
- Sponsor's protocol ID
- Sao Paulo University
- Acronym
- AMDCELL
- Status last verified
- Jul 2017
- First submitted
- 20 Sep 2011
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravitreal Bone Marrow-Derived Stem Cells in Patients With Macular Degeneration
- ClinicalTrials.gov ID
- NCT01518127
- Acronym / sponsor ID
- AMDCELL / Sao Paulo University
- Keywords
- Macular Degeneration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 25 Jan 2012 (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 study is to evaluate the behavior of intravitreal injection of of autologous bone marrow stem cells in patients with age related macular degeneration.
Detailed description
A prospective phase I/II, nonrandomized open-label study of agen related macular degeneration and Stargartd patients with best-corrected ETDRS visual acuity (BCVA) worse than 20/200. Standardized ophthalmic evaluation will be perform at baseline and at weeks 1, 4,12 and 24 (±1) following intravitreal injection of 10 x 106 bone marrow stem cells/ 0,1ml . Three measures will be used to evaluate the short-term safety of intravitreal of bone marrow stem cells: 1) severe visual loss, defined as a drop in 15 letters on ETDRS visual acuity scale; 2) decrease in ERG response; 3) decrease in 5 square degrees on visual field; secondary safety outcomes : 1) increase in intra-ocular inflammation defined herein as anterior chamber cells and flare higher than 3+ for more than 1 month after injection according to a classification described elsewhere ; 2) decrease in CMT more than 50um; 3)genesis of abnormal tissues (teratomas) or tumors; 4) qualitative changes in retinal or choroidal perfusion, like macular nonperfusion. Secondary outcome measures will be used to evaluate the short-term efficiency of intravitreal of Bone Marrow Stem Cells: 1) improvement in ERG response; 2) increase in visual field: 3) increase in CSMT > 50um and not related to macular edemar or choroidal neovascularization; 4) increase > 5 letters on BCVA
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- intravitreal injection of autologous bone marrow stem cells
| Arm | Type | Receives |
|---|---|---|
| stem cell group | Experimental | Other: intravitreal injection of autologous bone marrow stem cellsintravitreal injection of autologous bone marrow stem cells |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female AMD and Stargartd patients 18 to 80 years old, inclusive.
- In either eye, diagnosis of geographic atrophy or choroidal neovascularization due to AMD
- ETDRS best corrected visual acuity of 60 letters or worse in the study eye.
Key exclusion criteria (8 listed)
- Retinal disease other than AMD in study eye which, in the investigator's opinion, may pose a safety risk or interfere with the study.
- Choroidal neovascularization due to a cause other than AMD.
- In the study eye, media opacity that interferes with fundus imaging or is likely to require surgery during the study period.
- Any of the following treatments to the study eye within 14 days prior to dosing: ranibizumab (Lucentis), bevacizumab (Avastin), pegaptanib (Macugen), or other VEGF inhibitor; OR likely requirement for one of the above treatments within 14 days of LFG316 administration.
- Any of the following within 30 days prior to dosing: photodynamic therapy treatment in the study eye; extrafoveal or juxtafoveal thermal laser photocoagulation in the study eye; systemic or topical (ophthalmic) steroid use in the study eye; bacterial keratitis in the study eye; OR intraocular surgery (including cataract surgery) in the fellow eye.
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 |
|---|---|---|
| intravitreal injection of autologous bone marrow stem cellsAlso: Cell Therapyintravitreal injection of autologous bone marrow stem cells | Other | stem cell group |
Primary outcome
ETDRS Visual acuity change
Time frame: Day 1 to Day 365
Primary safety outcome included visual acuity loss of 15 or more ETDRS letters after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
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.
Rubens C Siqueira, MD,PhD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intravitreal injection of autologous bone marrow stem cells in people with Age Related Macular Degeneration and Stargartd, run by University of Sao Paulo at 1 site in Brazil.
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 3 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: finished, as of the sponsor's last update on 21 Jul 2017. 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 Brazil. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ETDRS Visual acuity change (time frame: Day 1 to Day 365). 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 21 Jul 2017.