Intravitreal Mesenchymal Stem Cell Transplantation in Advanced Glaucoma.

Retinal Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02330978
• Other study ID #: HCRP 14151/2010
• Status: Completed
• Phase: Phase 1
• Start date: January 2014
• Est. completion date: September 2016

Study information

• Verified date: April 2019
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Primary Open-angle Glaucoma
• Retinal Degeneration

Intervention

Procedure:
• Intravitreal transplantation of mesenchymal stem cell

Biological:
• Culture and isolation of autologous bone-marrow mesenchymal stem cells

Locations

Country	Name	City	State
Brazil	Ribeirão Preto Medical School	Ribeirao Preto	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Conselho Nacional de Desenvolvimento Científico e Tecnológico

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Type and Severity of Adverse Effects (AE) and Adverse Reactions (AR)	Retinal detachment	6 months
Secondary	Changes in Visual Acuity		6 months
Secondary	Changes in Visual Field		6 months
Secondary	Changes in Optical Coherence Tomography Parameters Related to Glaucoma		6 months
Secondary	Changes in Retinal Ganglion Cells Function by ERG		6 months