IschemiaRetinaCellNCT01518842
Effect of Intravitreal Bone Marrow Stem Cells on Ischemic Retinopathy
A study testing Intravitreal Bone Marrow Stem Cells in people with Ischemia, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
This study aims to evaluate the behavior of the intravitreal use of bone marrow derived stem cells in patients with ischemic retinopathy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ischemia
- What is being tested?
- Intravitreal Bone Marrow Stem Cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2011to Jan 2020
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of Ischemic Retinopathy
- Enlargement of foveal avascular zone-FAZ (ischaemia or capillary drop out of >30% on Fluorescein retinography
- logarithm of minimum angle of resolution (logMAR) BCVA of 1.0 (Snellen equivalent, 20/200) or worse
- Able (in the Investigator's opinion) and willing to comply with all study requirements
Who cannot join
- previous ocular surgery other than cataract
- presence of cataract or other media opacity that would influence ocular fundus documentation and adequate ERG and visual field evaluation
- other ophthalmic disease like glaucoma and uveitis
- previous history of blood disorders like leukemia
- known allergy to fluorescein or indocyanine green
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
This study aims to evaluate the behavior of the intravitreal use of bone marrow derived stem cells in patients with ischemic retinopathy.
Read the detailed description
Evaluate the effects on visual acuity, electroretinography, fluorescein angiography and optical coherence tomography in 30 patients with ischemic retinopathy, including diabetic retinopathy with severe loss of retinal capillaries undergoing intravitreal injection of bone marrow derived stem cells.
- Conditions
- Ischemia
- Being tested
- Intravitreal Bone Marrow Stem Cells
- Keywords
- ischemic retinopathy, stem cell,bone marrow
- Medical subject headings
- Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal Bone Marrow Stem CellsBiological
One intravitreal injection of a 0.1-ml cell suspension containing around 10x106 bone marrow mononuclear stem cells(BMMSC). All treatments were performed by a single retinal specialist using topical proparacaine drops under sterile conditions (eyelid speculum and povidone-iodine). Autologous BMMSC were injected into the vitreous cavity using a 27 gauge needle inserted through the inferotemporal pars plana 3.0 - 3.5 mm posterior to the limbus. After the injection, central retinal artery perfusion was confirmed with indirect ophthalmoscopy. Patients were instructed to instill one drop of 0.3% ciprofloxacin into the injected eye four times daily for 1 week after the procedure.
| Study group | Role | What they receive |
|---|---|---|
| test group intravitreal stem cell | Experimental | Open-label study of Ischemic Retinopathy patients with best-corrected visual acuity (BCVA) worse than 20/200.
Intervention: Biological: intravitreal injection of autologous bone marrow stem cells Receives: Biological: Intravitreal Bone Marrow Stem Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in size of FAZ at 48 weeks
Measured: 1 day to 48 weeks
Secondary outcomes (1)
Change in central foveal thickness and best corrected visual acuity at 48 weeks
Measured: 1 day to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2012 (estimated)
- Study startSep 2011
- Primary completionOct 2018
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IschemiaStudies 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
- 30 participants (estimated)
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, Rubens Siqueira Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01518842
- Sponsor's protocol ID
- Siqueira Research Center
- Acronym
- RetinaCell
- Status last verified
- Oct 2018
- First submitted
- 22 Jan 2012
- Last updated
- 16 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Siqueira RC, Messias A, Gurgel VP, Simoes BP, Scott IU, Jorge R. Improvement of ischaemic macular oedema after intravitreal injection of autologous bone marrow-derived haematopoietic stem cells. Acta Ophthalmol. 2015 Mar;93(2):e174-6. doi: 10.1111/aos.12473. Epub 2014 Jun 22. No abstract available.
PubMed 24954079
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravitreal Bone Marrow Stem Cells on Ischemic Retinopathy
- ClinicalTrials.gov ID
- NCT01518842
- Acronym / sponsor ID
- RetinaCell / Siqueira Research Center
- Conditions
- Ischemia
- Keywords
- ischemic retinopathy, stem cell,bone marrow
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Oct 2018 (actual)
- Study completion
- Jan 2020 (estimated)
- First posted
- 26 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.
This study aims to evaluate the behavior of the intravitreal use of bone marrow derived stem cells in patients with ischemic retinopathy.
Detailed description
Evaluate the effects on visual acuity, electroretinography, fluorescein angiography and optical coherence tomography in 30 patients with ischemic retinopathy, including diabetic retinopathy with severe loss of retinal capillaries undergoing intravitreal injection of bone marrow derived stem cells.
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 |
|---|---|---|
| test group intravitreal stem cell | Experimental | Biological: Intravitreal Bone Marrow Stem CellsOpen-label study of Ischemic Retinopathy patients with best-corrected visual acuity (BCVA) worse than 20/200. Intervention: Biological: intravitreal injection of autologous bone marrow stem cells |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosis of Ischemic Retinopathy
- Enlargement of foveal avascular zone-FAZ (ischaemia or capillary drop out of >30% on Fluorescein retinography
- logarithm of minimum angle of resolution (logMAR) BCVA of 1.0 (Snellen equivalent, 20/200) or worse
- Able (in the Investigator's opinion) and willing to comply with all study requirements
Key exclusion criteria (5 listed)
- previous ocular surgery other than cataract
- presence of cataract or other media opacity that would influence ocular fundus documentation and adequate ERG and visual field evaluation
- other ophthalmic disease like glaucoma and uveitis
- previous history of blood disorders like leukemia
- known allergy to fluorescein or indocyanine green
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 Bone Marrow Stem CellsOne intravitreal injection of a 0.1-ml cell suspension containing around 10x106 bone marrow mononuclear stem cells(BMMSC). All treatments were performed by a single retinal specialist using topical proparacaine drops under sterile conditions (eyelid speculum and povidone-iodine). Autologous BMMSC were injected into the vitreous cavity using a 27 gauge needle inserted through the inferotemporal pars plana 3.0 - 3.5 mm posterior to the limbus. After the injection, central retinal artery perfusion was confirmed with indirect ophthalmoscopy. Patients were instructed to instill one drop of 0.3% ciprofloxacin into the injected eye four times daily for 1 week after the procedure. | Biological | test group intravitreal stem cell |
Primary outcome
Change in size of FAZ at 48 weeks
Time frame: 1 day to 48 weeks
1 secondary outcome
Change in central foveal thickness and best corrected visual acuity at 48 weeks
Time frame: 1 day to 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2018.
- Background: PubMed 24954079Siqueira RC, Messias A, Gurgel VP, Simoes BP, Scott IU, Jorge R. Improvement of ischaemic macular oedema after intravitreal injection of autologous bone marrow-derived haematopoietic stem cells. Acta Ophthalmol. 2015 Mar;93(2):e174-6. doi: 10.1111/aos.12473. Epub 2014 Jun 22. No abstract available.
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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.
Rubens C Siqueira, MD, PhD principal investigator
Rubens Siqueira Research Center
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 Bone Marrow Stem Cells in people with Ischemia, 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 4 inclusion and 5 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 16 Oct 2018. 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?
Results are not available in the source record.
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?
Change in size of FAZ at 48 weeks (time frame: 1 day to 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01518842, which also lists 1 linked publication.
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 16 Oct 2018.