CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 2 enrolled
Drug / intervention
Culture and isolation of autologous bone-marrow mesenchymal stem cells +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02330978
NCT02330978Phase 1Completed

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

University of Sao Paulo·interventional·Posted Jan 5, 2015·Updated Jul 8, 2019

In Brief

A Phase 1 clinical trial evaluating Intravitreal transplantation of mesenchymal stem cell and Culture and isolation of autologous bone-marrow mesenchymal stem cells for Retinal Degeneration and Primary Open-angle Glaucoma. Completed, enrolled 2 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBrazil

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 5, 2015
Enrollment StartJan 1, 2014
Primary CompletionSep 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 11.5 years ago

Interventions

Intravitreal transplantation of mesenchymal stem cellprocedure

Culture and isolation of autologous bone-marrow mesenchymal stem cellsbiological