Intravitreal Autologous Bone Marrow-derived Mesenchymal Stem Cell Transplantation in Patients With Advanced Glaucoma. Phase I: Safety Study.
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Retinal Degeneration
- Sponsor
- University of Sao Paulo
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Type and Severity of Adverse Effects (AE) and Adverse Reactions (AR)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
JAYTER SILVA DE PAULA
Associate Professor
University of Sao Paulo
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.
Outcomes
Primary Outcomes
Type and Severity of Adverse Effects (AE) and Adverse Reactions (AR)
Time Frame: 6 months
Retinal detachment
Secondary Outcomes
- 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)