Intravitreal Mesenchymal Stem Cell Transplantation in Advanced Glaucoma.

• Sponsor: University of Sao Paulo (Other)
• Overall Status: Completed
• CT.gov ID: NCT02330978
• Collaborator: Conselho Nacional de Desenvolvimento Científico e Tecnológico (Other)
• Enrollment: 2
• Location: 1
• Arm: 1
• Duration (Months): 32
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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 Design

• Study Type: Interventional
• 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: Jan 1, 2014
• Actual Primary Completion Date: Sep 1, 2016
• Actual Study Completion Date: Sep 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Type and Severity of Adverse Effects (AE) and Adverse Reactions (AR) [6 months]

   Retinal detachment

Secondary Outcome Measures

1. Changes in Visual Acuity [6 months]

2. Changes in Visual Field [6 months]

3. Changes in Optical Coherence Tomography Parameters Related to Glaucoma [6 months]

4. Changes in Retinal Ganglion Cells Function by ERG [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

• Principal Investigator: Jayter S Paula, MD, Associate Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Jan 5, 2015
• Last Update Posted: Jul 8, 2019
• Last Verified: Apr 1, 2019

• Additional relevant MeSH terms: Glaucoma; Glaucoma, Open-Angle; Retinal Degeneration

Study Results

Participant Flow

Pre-assignment Detail	The study requisits to enroll patients are too tight and some patients selected do not atend to all admision requisits like vision acuity worse than 20/100 in both eyes, absence of systemic comorbidities, etc.

Arm/Group Title	MSC Transplantion
Arm/Group Description	One group of glaucomatous patients will receive 10(6) autologous bone marrow-derived mesenchymal stem cells transplantation into their worst eye, through an unique intravitreal injections, under anesthesia. Intravitreal transplantation of mesenchymal stem cell Culture and isolation of autologous bone-marrow mesenchymal stem cells
Period Title: The First Patient Included at Study
STARTED	1
COMPLETED	1
NOT COMPLETED	0
Period Title: The First Patient Included at Study
STARTED	1
COMPLETED	1
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	The First Patient Included at Study
Arm/Group Description	On the thirtieth day after the vitreous injection a combined serous retinal detachment with proliferative vitreoretinopathy was noticed in patient 1 - promptly treated with a successful pars plana vitrectomy and silicone oil tamponade. At the final follow-up period (12 months), he remained with no retinal detachment and light perception vision.
Overall Participants	2
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	1 50%
>=65 years	1 50%
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	2 100%
Region of Enrollment (participants) [Number]
Brazil	2 100%

Outcome Measures

1. Primary Outcome

Title	Type and Severity of Adverse Effects (AE) and Adverse Reactions (AR)
Description	Retinal detachment
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	The First Patient Included at Study
Arm/Group Description	On the thirtieth day after the vitreous injection a combined serous retinal detachment with proliferative vitreoretinopathy was noticed in patient 1 - promptly treated with a successful pars plana vitrectomy and silicone oil tamponade. At the final follow-up period (12 months), he remained with no retinal detachment and light perception vision.
Measure Participants	1
Count of Participants [Participants]	1 50%

2. Secondary Outcome

Title	Changes in Visual Acuity
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Changes in Visual Field
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Changes in Optical Coherence Tomography Parameters Related to Glaucoma
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

Title	Changes in Retinal Ganglion Cells Function by ERG
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	The First Patient Included at Study
Arm/Group Description	On the thirtieth day after the vitreous injection a combined serous retinal detachment with proliferative vitreoretinopathy was noticed in patient 1 - promptly treated with a successful pars plana vitrectomy and silicone oil tamponade. At the final follow-up period (12 months), he remained with no retinal detachment and light perception vision.
All Cause Mortality
	The First Patient Included at Study
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	The First Patient Included at Study
	Affected / at Risk (%)	# Events
Total	1/2 (50%)
Eye disorders
Retinal detachment	1/2 (50%)	1
Other (Not Including Serious) Adverse Events
	The First Patient Included at Study
	Affected / at Risk (%)	# Events
Total	0/2 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.