NCT02330978

Intravitreal Mesenchymal Stem Cell Transplantation in Advanced Glaucoma.

Intravitreal Autologous Bone Marrow-derived Mesenchymal Stem Cell Transplantation in Patients With Advanced Glaucoma. Phase I: Safety Study.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: All
• Age: 40 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Retinal Degeneration
• Primary Open-angle Glaucoma

Interventions

Type	Name	Description
PROCEDURE	Intravitreal transplantation of mesenchymal stem cell
BIOLOGICAL	Culture and isolation of autologous bone-marrow mesenchymal stem cells

Timeline

• Start date: 2014-01-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2015-01-05
• Last updated: 2019-07-08
• Results posted: 2019-07-08

Locations

1 site across 1 country: Brazil