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Trial record 1 of 1 for:    NCT02330978
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Intravitreal Mesenchymal Stem Cell Transplantation in Advanced Glaucoma.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02330978
Recruitment Status : Completed
First Posted : January 5, 2015
Results First Posted : July 8, 2019
Last Update Posted : July 8, 2019
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
JAYTER SILVA DE PAULA, University of Sao Paulo

Brief 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.

Condition or disease Intervention/treatment Phase
Retinal Degeneration Primary Open-angle Glaucoma Procedure: Intravitreal transplantation of mesenchymal stem cell Biological: Culture and isolation of autologous bone-marrow mesenchymal stem cells Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intravitreal Autologous Bone Marrow-derived Mesenchymal Stem Cell Transplantation in Patients With Advanced Glaucoma. Phase I: Safety Study.
Study Start Date : January 2014
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Experimental: 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.
Procedure: Intravitreal transplantation of mesenchymal stem cell
Biological: Culture and isolation of autologous bone-marrow mesenchymal stem cells



Primary Outcome Measures :
  1. Type and Severity of Adverse Effects (AE) and Adverse Reactions (AR) [ Time Frame: 6 months ]
    Retinal detachment


Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02330978


Locations
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Brazil
Ribeirão Preto Medical School
Ribeirao Preto, Sao Paulo, Brazil, 14049900
Sponsors and Collaborators
University of Sao Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
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Principal Investigator: Jayter S Paula, MD Associate Professor
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Responsible Party: JAYTER SILVA DE PAULA, Associate Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02330978    
Other Study ID Numbers: HCRP 14151/2010
First Posted: January 5, 2015    Key Record Dates
Results First Posted: July 8, 2019
Last Update Posted: July 8, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Retinal Degeneration
Ocular Hypertension
Eye Diseases
Eye Diseases, Hereditary
Retinal Diseases