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| Name | Class |
|---|---|
| Conselho Nacional de Desenvolvimento CientÃfico e Tecnológico | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravitreal transplantation of mesenchymal stem cell | Procedure |
| ||
| Culture and isolation of autologous bone-marrow mesenchymal stem cells |
| Measure | Description | Time Frame |
|---|---|---|
| Type and Severity of Adverse Effects (AE) and Adverse Reactions (AR) | Retinal detachment | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Visual Acuity | 6 months | |
| Changes in Visual Field | 6 months | |
| Changes in Optical Coherence Tomography Parameters Related to Glaucoma |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jayter S Paula, MD | Associate Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ribeirão Preto Medical School | Ribeirão Preto | São Paulo | 14049900 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33469852 | Derived | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | MSC Transplantion | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| The First Patient Included at Study |
| |||||||||||||
| The Second Patient Included at Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Type and Severity of Adverse Effects (AE) and Adverse Reactions (AR) | Retinal detachment | Posted | Count of Participants | Participants | 6 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Retinal detachment | Eye disorders | A combined serous retinal detachment with proliferative vitreoretinopathy was noticed in patient 1 - treated with vitrectomy and silicone oil tamponade. At the final follow-up period he remained with no retinal detachment and light perception vision. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jayter Silva de Paula, MD, PhD | University São Paulo | 55 16 3602-2499 | jspaula@fmrp.usp.br |
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| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D012164 | Retinal Diseases |
| D005901 | Glaucoma |
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| ID | Term |
|---|---|
| D046508 | Culture Techniques |
| ID | Term |
|---|---|
| D066298 | In Vitro Techniques |
| D008919 | Investigative Techniques |
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| Biological |
|
| 6 months |
| Changes in Retinal Ganglion Cells Function by ERG | 6 months |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Changes in Visual Acuity | Not Posted | 6 months | Participants |
| Secondary | Changes in Visual Field | Not Posted | 6 months | Participants |
| Secondary | Changes in Optical Coherence Tomography Parameters Related to Glaucoma | Not Posted | 6 months | Participants |
| Secondary | Changes in Retinal Ganglion Cells Function by ERG | Not Posted | 6 months | Participants |
| 1 |
| 2 |
| 0 |
| 2 |
|
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| D009798 |
| Ocular Hypertension |