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Intravitreal Mesenchymal Stem Cell Transplantation in Advanced Glaucoma.

Primary Purpose

Retinal Degeneration, Primary Open-angle Glaucoma

Status
Completed
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Intravitreal transplantation of mesenchymal stem cell
Culture and isolation of autologous bone-marrow mesenchymal stem cells
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinal Degeneration

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Sites / Locations

  • Ribeirão Preto Medical School

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MSC transplantion

Arm Description

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.

Outcomes

Primary Outcome Measures

Type and Severity of Adverse Effects (AE) and Adverse Reactions (AR)
Retinal detachment

Secondary Outcome Measures

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

Full Information

First Posted
December 31, 2014
Last Updated
April 16, 2019
Sponsor
University of Sao Paulo
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
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1. Study Identification

Unique Protocol Identification Number
NCT02330978
Brief Title
Intravitreal Mesenchymal Stem Cell Transplantation in Advanced Glaucoma.
Official Title
Intravitreal Autologous Bone Marrow-derived Mesenchymal Stem Cell Transplantation in Patients With Advanced Glaucoma. Phase I: Safety Study.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Degeneration, Primary Open-angle Glaucoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MSC transplantion
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Intravitreal transplantation of mesenchymal stem cell
Intervention Type
Biological
Intervention Name(s)
Culture and isolation of autologous bone-marrow mesenchymal stem cells
Primary Outcome Measure Information:
Title
Type and Severity of Adverse Effects (AE) and Adverse Reactions (AR)
Description
Retinal detachment
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Changes in Visual Acuity
Time Frame
6 months
Title
Changes in Visual Field
Time Frame
6 months
Title
Changes in Optical Coherence Tomography Parameters Related to Glaucoma
Time Frame
6 months
Title
Changes in Retinal Ganglion Cells Function by ERG
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Severe systemic morbidities; Other ocular blind conditions associated; Impossibility in performing any of the proposed examinations.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jayter S Paula, MD
Organizational Affiliation
Associate Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ribeirão Preto Medical School
City
Ribeirao Preto
State/Province
Sao Paulo
ZIP/Postal Code
14049900
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
33469852
Citation
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.
Results Reference
derived

Learn more about this trial

Intravitreal Mesenchymal Stem Cell Transplantation in Advanced Glaucoma.

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