CompletedPhase 1

Intravitreal Mesenchymal Stem Cell Transplantation in Advanced Glaucoma.

Brazil2 participantsStarted 2014-01

Plain-language 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.

Who can participate

Age range40 Years – 90 Years

SexALL

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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.

What they're measuring

Type and Severity of Adverse Effects (AE) and Adverse Reactions (AR)

Timeframe: 6 months

Trial details

NCT IDNCT02330978

SponsorUniversity of Sao Paulo

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-09

Results submitted2019-04-16

View on ClinicalTrials.gov More Retinal Degeneration trials