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OpenTrials
Completed

NCT Number: NCT02330978

Intravitreal Mesenchymal Stem Cell Transplantation in Advanced Glaucoma.

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.

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Key information

Conditions

Retinal Degeneration Eye Diseases Eye Diseases, Hereditary Glaucoma Glaucoma, Open-Angle Ocular Hypertension Primary Open-Angle Glaucoma Retinal Diseases

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Ribeirão Preto Medical School

Ribeirão Preto, São Paulo, 14049900, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intravitreal transplantation of mesenchymal stem cell

Procedure

Culture and isolation of autologous bone-marrow mesenchymal stem cells

Biological

Primary outcomes

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

    Time frame: 6 months

    Retinal detachment

Secondary outcomes

  1. Changes in Visual Acuity

    Time frame: 6 months

  2. Changes in Visual Field

    Time frame: 6 months

  3. Changes in Optical Coherence Tomography Parameters Related to Glaucoma

    Time frame: 6 months

  4. Changes in Retinal Ganglion Cells Function by ERG

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jan 5, 2015
Registry last updated
Jul 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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