NCT02330978

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2014

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 31, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 5, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

July 8, 2019

Completed
Last Updated

July 8, 2019

Status Verified

April 1, 2019

Enrollment Period

2.7 years

First QC Date

December 31, 2014

Results QC Date

April 16, 2019

Last Update Submit

April 16, 2019

Conditions

Retinal DegenerationPrimary Open-angle Glaucoma

Outcome Measures

Primary Outcomes (1)

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

    Retinal detachment

    6 months

Secondary Outcomes (4)

  • Changes in Visual Acuity

    6 months

  • Changes in Visual Field

    6 months

  • Changes in Optical Coherence Tomography Parameters Related to Glaucoma

    6 months

  • Changes in Retinal Ganglion Cells Function by ERG

    6 months

Study Arms (1)

MSC transplantion

EXPERIMENTAL

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 cellBiological: Culture and isolation of autologous bone-marrow mesenchymal stem cells

Interventions

Intravitreal transplantation of mesenchymal stem cellPROCEDURE
MSC transplantion
Culture and isolation of autologous bone-marrow mesenchymal stem cellsBIOLOGICAL
MSC transplantion

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Severe systemic morbidities;
  • Other ocular blind conditions associated;
  • Impossibility in performing any of the proposed examinations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ribeirão Preto Medical School

Ribeirão Preto, São Paulo, 14049900, Brazil

Location

Related Publications (1)

  • Vilela CAP, Messias A, Calado RT, Siqueira RC, Silva MJL, Covas DT, Paula JS. Retinal function after intravitreal injection of autologous bone marrow-derived mesenchymal stromal cells in advanced glaucoma. Doc Ophthalmol. 2021 Aug;143(1):33-38. doi: 10.1007/s10633-021-09817-z. Epub 2021 Jan 19.

    PMID: 33469852DERIVED

MeSH Terms

Conditions

Retinal DegenerationGlaucoma, Open-Angle

Interventions

Culture Techniques

Condition Hierarchy (Ancestors)

Eye Diseases, HereditaryEye DiseasesRetinal DiseasesGlaucomaOcular Hypertension

Intervention Hierarchy (Ancestors)

In Vitro TechniquesInvestigative Techniques

Results Point of Contact

Title
Jayter Silva de Paula, MD, PhD
Organization
University São Paulo
jspaula@fmrp.usp.br
55 16 3602-2499

Study Officials

  • Jayter S Paula, MD

    Associate Professor

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 31, 2014

First Posted

January 5, 2015

Study Start

January 1, 2014

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

July 8, 2019

Results First Posted

July 8, 2019

Record last verified: 2019-04

Locations

BR(1)