Intravitreal Mesenchymal Stem Cell Transplantation in Advanced Glaucoma.

University of Sao Paulo2 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Retinal Degeneration Primary Open-angle Glaucoma

Interventions

Eligibility

Sex: ALLMin age: 40 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Retinal detachment

Time frame: 6 months

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

Intravitreal Mesenchymal Stem Cell Transplantation in Advanced Glaucoma.

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes