Retinal DegenerationPhase 1NCT02330978

Intravitreal Mesenchymal Stem Cell Transplantation in Advanced Glaucoma.

A Phase 1 study testing Intravitreal transplantation of mesenchymal stem cell and Culture and isolation of autologous bone-marrow mesenchymal stem cells in people with Retinal Degeneration and Primary Open-angle Glaucoma, run by University of Sao Paulo at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 40 to 90 years
Conditions the study is for: Retinal Degeneration, Primary Open-angle Glaucoma
What is being tested?: Intravitreal transplantation of mesenchymal stem cell and Culture and isolation of autologous bone-marrow mesenchymal stem cells
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2 participants
Where: 1 siteBrazil
Study dates: Jan 2014to Sep 2016
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 40 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of Advanced Bilateral Open-Angle Glaucoma;
Best corrected visual acuity less than 0,1 in the better eye;
Social and cognitive ability to participate.

Who cannot join

Severe systemic morbidities;
Other ocular blind conditions associated;
Impossibility in performing any of the proposed examinations.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Ribeirão Preto Medical School
Ribeirão Preto, São Paulo, 14049900

Other trials in Brazil

About this study

Official title: Intravitreal Autologous Bone Marrow-derived Mesenchymal Stem Cell Transplantation in Patients With Advanced Glaucoma. Phase I: Safety Study.

Bone marrow-derived mesenchymal stem cells (MSC) therapy is a promising treatment for several degenerative diseases, including retinopathies and glaucoma, however no previous safety study involving humans has been conducted. The objective of this study is to evaluate effects of autologous bone marrow-derived MSC transplantation in the worst eye of 10 patients with legal bilateral blindness due to glaucoma. Primary outcome are types and severity of adverse effects. Secondary outcomes are changes in visual field, visual acuity, optical coherence tomography, and retinal ganglion cells function.

Conditions: Retinal Degeneration, Primary Open-angle Glaucoma
Being tested: Intravitreal transplantation of mesenchymal stem cell, Culture and isolation of autologous bone-marrow mesenchymal stem cells
Medical subject headings: Retinal Degeneration, Glaucoma, Open-Angle

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Intravitreal transplantation of mesenchymal stem cellProcedure or surgery
Culture and isolation of autologous bone-marrow mesenchymal stem cellsBiological

Study groups in NCT02330978
Study group	Role	What they receive
MSC transplantion	Experimental	One group of glaucomatous patients will receive 10(6) autologous bone marrow-derived mesenchymal stem cells transplantation into their worst eyes, through an unique intravitreal injections, under anesthesia. Receives: Procedure: Intravitreal transplantation of mesenchymal stem cell; Biological: Culture and isolation of autologous bone-marrow mesenchymal stem cells

What is being measured

The primary outcome is the main question the study is designed to answer.

Type and Severity of Adverse Effects (AE) and Adverse Reactions (AR)
Retinal detachment
Measured: 6 months

Secondary outcomes (4)

Changes in Visual Acuity
Measured: 6 months
Changes in Visual Field
Measured: 6 months
Changes in Optical Coherence Tomography Parameters Related to Glaucoma
Measured: 6 months
Changes in Retinal Ganglion Cells Function by ERG
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2014Sep 2016

First posted5 Jan 2015 (estimated)
Study startJan 2014
Primary completionSep 2016
Study completionSep 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Retinal DegenerationStudies 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 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 2 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02330978
Sponsor's protocol ID: HCRP 14151/2010
Status last verified: Apr 2019
First submitted: 31 Dec 2014
Last updated: 8 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Vilela CAP, Messias A, Calado RT, Siqueira RC, Silva MJL, Covas DT, Paula JS. Retinal function after intravitreal injection of autologous bone marrow-derived mesenchymal stromal cells in advanced glaucoma. Doc Ophthalmol. 2021 Aug;143(1):33-38. doi: 10.1007/s10633-021-09817-z. Epub 2021 Jan 19.
PubMed 33469852

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intravitreal Autologous Bone Marrow-derived Mesenchymal Stem Cell Transplantation in Patients With Advanced Glaucoma. Phase I: Safety Study.
ClinicalTrials.gov ID: NCT02330978
Acronym / sponsor ID: HCRP 14151/2010
Conditions: Retinal Degeneration, Primary Open-angle Glaucoma
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 2 participants (actual)
Lead sponsor: University of Sao PauloUniversity, hospital or other
Collaborators: Conselho Nacional de Desenvolvimento Científico e Tecnológico
Study start: Jan 2014
Primary completion: Sep 2016 (actual)
Study completion: Sep 2016 (actual)
First posted: 5 Jan 2015 (estimated)
Results: Posted 8 Jul 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
MSC transplantion	Experimental	Procedure: Intravitreal transplantation of mesenchymal stem cell, Biological: Culture and isolation of autologous bone-marrow mesenchymal stem cellsOne group of glaucomatous patients will receive 10(6) autologous bone marrow-derived mesenchymal stem cells transplantation into their worst eyes, through an unique intravitreal injections, under anesthesia.

Who may qualify

Ages: 40 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Diagnosis of Advanced Bilateral Open-Angle Glaucoma;
Best corrected visual acuity less than 0,1 in the better eye;
Social and cognitive ability to participate.

Key exclusion criteria (3 listed)

Severe systemic morbidities;
Other ocular blind conditions associated;
Impossibility in performing any of the proposed examinations.

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 transplantation of mesenchymal stem cell	Procedure or surgery	MSC transplantion
Culture and isolation of autologous bone-marrow mesenchymal stem cells	Biological	MSC transplantion

Primary outcome

Type and Severity of Adverse Effects (AE) and Adverse Reactions (AR)
Time frame: 6 months
Retinal detachment

4 secondary outcomes

Changes in Visual Acuity
Time frame: 6 months
Changes in Visual Field
Time frame: 6 months
Changes in Optical Coherence Tomography Parameters Related to Glaucoma
Time frame: 6 months
Changes in Retinal Ganglion Cells Function by ERG
Time frame: 6 months

Results and safety

Results posted to the registry on 8 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MSC Transplantion	1	1

Primary outcome: Type and Severity of Adverse Effects (AE) and Adverse Reactions (AR)

Time frame: 6 months. Count of participants. Unit: Participants

Measure	The First Patient Included at Study n = 1
Value	1

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
The First Patient Included at Study	1 of 2 (50%)	0 of 2 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33469852Vilela CAP, Messias A, Calado RT, Siqueira RC, Silva MJL, Covas DT, Paula JS. Retinal function after intravitreal injection of autologous bone marrow-derived mesenchymal stromal cells in advanced glaucoma. Doc Ophthalmol. 2021 Aug;143(1):33-38. doi: 10.1007/s10633-021-09817-z. Epub 2021 Jan 19.

Related trials for Retinal Degeneration

RecruitingObservational study
Pivotal Trial of an Automated AI-based System for Early Diagnosis and Prediction of Late Age-related Macular Degeneration
Age-related Macular Degeneration (AMD)
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingObservational study
Retinal Pigment Epithelium Safety Study For Patients In B4711001
Age Related Macular Degeneration
RecruitingObservational study
National Ophthalmic Genotyping and Phenotyping Network (eyeGENE (Registered Trademark)), Stage 3 - Expansion of DNA and Data Repositories for Rare Inherited Ophthalmic Diseases
Inherited Ophthalmic Diseases, Hypopigmentation Disorder
Active, not recruitingPhase 1/2
Phase 1/2 Study of VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration
Age-Related Macular Degeneration, Geographic Atrophy

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.

Jayter S Paula, MD principal investigator

Associate Professor

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 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 8 Jul 2019. 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.

What does this 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.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Type and Severity of Adverse Effects (AE) and Adverse Reactions (AR) (time frame: 6 months). 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 NCT02330978, 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 8 Jul 2019.