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

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ClinicalTrials.gov Identifier: NCT02330978
Recruitment Status : Unknown
Verified July 2016 by JAYTER SILVA DE PAULA, University of Sao Paulo.
Recruitment status was:  Recruiting
First Posted : January 5, 2015
Last Update Posted : July 6, 2016
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
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
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : December 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 ]

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


Contacts
Contact: Carolina P Assis, MD +5516981027642 carolassisp@yahoo.com.br
Contact: Maria C Onofre mcecilia1805@gmail.com

Locations
Brazil
Ribeirão Preto Medical School Recruiting
Ribeirao Preto, Sao Paulo, Brazil, 14049900
Contact: Maria C Onofre       mcecilia1805@gmail.com   
Sponsors and Collaborators
University of Sao Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
Principal Investigator: Jayter S Paula, MD Associate Professor

Responsible Party: JAYTER SILVA DE PAULA, Associate Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02330978     History of Changes
Other Study ID Numbers: HCRP 14151/2010
First Posted: January 5, 2015    Key Record Dates
Last Update Posted: July 6, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Retinal Degeneration
Ocular Hypertension
Eye Diseases
Retinal Diseases