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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000618-12 | EudraCT Number |
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| Name | Class |
|---|---|
| Spanish National Health System | OTHER |
| Hospital Universitario Virgen de la Arrixaca | OTHER |
| Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia | OTHER |
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The purpose of this study is to evaluate the safety of intravitreal injection of autologous bone marrow stem cells in patients with retinitis pigmentosa by a prospective, single-center, randomized, parallel, double-blind, phase I placebo-controlled clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravitreal injection of Autologous bone marrow Stem Cell | Experimental | Patients included in the trial will receive a pars plana intravitreal injection of autologous mononuclear cells (MNC) of bone marrow (BM) in one eye (experimental group A or group). The eye in which autologous BM MNCs were injected will be determined randomly. The average dose will be 30 million of cells (5-60 million) diluted in 0.1 ml. of saline. |
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| Subconjunctival injection of saline | Placebo Comparator | Patients included in the trial will receive a subconjunctival injection of 0.1 ml of saline (SF) (placebo) in the fellow eye (group B or control group). In this way the patient will receive an injection in the control eye but avoid the risks of intraocular injection. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravitreal injection of Autologous bone marrow Stem Cell | Biological | We will proceed to the injection of 0.1 ml of the suspension with the autologous MNC of BM avoiding coincide with conjunctival and scleral hole and perpendicular to the sclera. After the injection, a dry, sterile dressing will be placed to prevent reflux. Immediately, the perception of light, the movement of the central retinal artery, the venous pulse and the color of the papilla will be evaluated. If necessary, anterior chamber paracentesis will be performed. After injection, the patient will remain with closed eyes and sitting, waiting for cells will be deposited on the bottom of the eyeball and for 3 days will instill tropicamide collyrium every 12 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of serious and non-serious adverse events related with the use of bone marrow mononuclear cells in patients with retinitis pigmentosa | 12 months from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life: Questionnaire VFQ-25 (Visual Function Questionnaire-25). | 12 months from baseline | |
| Visual acuity (VA): Test ETDRS (Early Treatment Diabetic Retinopathy Study). | 12 months from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MarÃa Elena Rodriguez González-Herrero, MD | Hospital Universitario Virgen de la Arrixaca | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Universitary Hospital Virgen de la Arrixaca | El Palmar | Murcia | 30120 | Spain |
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| Public Health Service, Murcia |
| OTHER |
| Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca | OTHER |
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| Subconjunctival injection of saline | Other | In the control eye, will make a subconjunctival injection of 0.1 ml saline. To realize contralateral injection gloves and all surgical materials will change, trying extreme measures of sterility. After injection, the patient will remain with closed eyes and sitting, waiting for cells will be deposited on the bottom of the eyeball and for 3 days will instill tropicamide collyrium every 12 hours. |
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| Color Vision: Ishihara Color Test. | 12 months from baseline |
| Contrast sensitivity: CSV-1000E. | 12 months from baseline |
| Intraocular pressure (IOP): measured in mm Hg with applanation tonometer Haag Streit AT 900. | 12 months from baseline |
| Examination of the anterior and posterior pole: Made with biomicroscopy (BMC). | 12 months from baseline |
| Width of retinal macula layer and nerve fiber: Measured with Optical Coherence Tomography Spectral domain (OCT)(Topcon 3D OCT-2000 Spectral Domain OCT). | 12 months from baseline |
| Visual field (VF) and macular sensitivity (The Humphrey perimeter). | 12 months from baseline |
| Study eye fundus: Made by Retinography and Angiography fluorescein. | 12 months from baseline |
| Electrical retinal function: electroretinogram (ERG) (altered / unaltered). | 12 months from baseline |
| Visual evoked potentials with Pattern Reversal (VEP) (altered / no altered). | 12 months from baseline |
| ID | Term |
|---|---|
| D012174 | Retinitis Pigmentosa |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D058499 | Retinal Dystrophies |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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