Intravitreal Mesenchymal Stem Cell Transplantation in Advanced Glaucoma.

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

How Safe and Effective is Micropulse Transscleral Cyclophotocoagulation in Patients With Uncontrolled Glaucoma?

NCT02627352

Glaucoma

COMPLETED NA

mRNA Expression in Lymphocytes of Glaucoma Patients

NCT00327509

Glaucoma Healthy Subjects

COMPLETED

Ocular Blood Flow Assessment in Glaucoma

NCT02178085

Glaucoma

UNKNOWN NA

Laminar Drainage Implant: Safety of a Novel Surgical Treatment for Refractory Glaucoma.

NCT03166566

Glaucoma Blindness, Acquired End-Stage Glaucoma +1 more

COMPLETED NA

Clinical Efficacy and Safety of Minimally Invasive Glaucoma Surgery on Primary Angle Closure Glaucoma

NCT02964676

Glaucoma, Angle-Closure

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Retinal Degeneration Primary Open-angle Glaucoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MSC transplantion

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.

Group Type EXPERIMENTAL

Intravitreal transplantation of mesenchymal stem cell

Intervention Type PROCEDURE

Culture and isolation of autologous bone-marrow mesenchymal stem cells

Intervention Type BIOLOGICAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intravitreal transplantation of mesenchymal stem cell

Intervention Type PROCEDURE

Culture and isolation of autologous bone-marrow mesenchymal stem cells

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.