Intravitreal Mesenchymal Stem Cell Transplantation in Advanced Glaucoma.

University of Sao Paulo

Status and phase: Completed; Phase 1

Conditions: Retinal Degeneration; Primary Open-angle Glaucoma

Treatments: Biological: Culture and isolation of autologous bone-marrow mesenchymal stem cells; Procedure: Intravitreal transplantation of mesenchymal stem cell

Study type: Interventional

Funder types: Other

Identifiers

NCT02330978

HCRP 14151/2010

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 40 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

2 participants in 1 patient group

MSC transplantion

Experimental group

Description:

One group of glaucomatous patients will receive 10(6) autologous bone marrow-derived mesenchymal stem cells transplantation into their worst eyes, through an unique intravitreal injections, under anesthesia.

Treatment:

Procedure: Intravitreal transplantation of mesenchymal stem cell

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