Phase 1
N=1
Intravitreal Mesenchymal Stem Cell Transplantation in Advanced Glaucoma.
Retinal Degeneration · Primary Open-angle Glaucoma
Bottom Line
View on ClinicalTrials.gov: NCT02330978 ↗Enrolled (actual)
1
Serious AEs
50.0%
Results posted
Jul 2019
Primary outcome: Primary: Type and Severity of Adverse Effects (AE) and Adverse Reactions (AR) — 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Intravitreal transplantation of mesenchymal stem cell (Procedure); Culture and isolation of autologous bone-marrow mesenchymal stem cells (Biological)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- University of Sao Paulo
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Type and Severity of Adverse Effects (AE) and Adverse Reactions (AR) |
1 | — |
| SECONDARY Changes in Visual Acuity |
— | — |
| SECONDARY Changes in Visual Field |
— | — |
| SECONDARY Changes in Optical Coherence Tomography Parameters Related to Glaucoma |
— | — |
| SECONDARY Changes in Retinal Ganglion Cells Function by ERG |
— | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02330978). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.