Primary Open-angle Glaucoma, Retinal Degeneration
Conditions
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.
Interventions
PROCEDUREIntravitreal transplantation of mesenchymal stem cell
BIOLOGICALCulture and isolation of autologous bone-marrow mesenchymal stem cells
Sponsors
Conselho Nacional de Desenvolvimento Científico e Tecnológico
University of Sao Paulo
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 90 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Type and Severity of Adverse Effects (AE) and Adverse Reactions (AR) | 6 months | Retinal detachment |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Brazil
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| The First Patient Included at Study 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. | 2 |
| Total | 2 |
Baseline characteristics
| Characteristic | The First Patient Included at Study |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Region of Enrollment Brazil | 2 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 2 |
| serious Total, serious adverse events | 1 / 2 |
Outcome results
Primary
Type and Severity of Adverse Effects (AE) and Adverse Reactions (AR)
Retinal detachment
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| The First Patient Included at Study | Type and Severity of Adverse Effects (AE) and Adverse Reactions (AR) | 1 Participants |
Secondary
Changes in Optical Coherence Tomography Parameters Related to Glaucoma
Time frame: 6 months
Secondary
Changes in Retinal Ganglion Cells Function by ERG
Time frame: 6 months
Secondary
Changes in Visual Acuity
Time frame: 6 months
Secondary
Changes in Visual Field
Time frame: 6 months