Intravitreal Mesenchymal Stem Cell Transplantation in Advanced Glaucoma.

Phase 1

Completed

• Conditions: Retinal Degeneration; Primary Open-angle Glaucoma
• Interventions: Procedure: Intravitreal transplantation of mesenchymal stem cell; Biological: Culture and isolation of autologous bone-marrow mesenchymal stem cells

• Registration Number: NCT02330978
• Lead Sponsor: University of Sao Paulo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-12-31
• Study First Submitted QC: 2014-12-31
• Study First Posted: 2015-01-05
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2019-04
• Results First Submitted: 2019-04-16
• Results First Submitted QC: 2019-04-16
• Last Update Submitted: 2019-04-16
• Results First Posted: 2019-07-08
• Last Update Posted: 2019-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MSC transplantion	Culture and isolation of autologous bone-marrow mesenchymal stem cells	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.
MSC transplantion	Intravitreal transplantation of mesenchymal stem cell	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ribeirão Preto Medical School; 🇧🇷 Ribeirao Preto, Sao Paulo, Brazil