Retinitis Pigmentosa Clinical Trial
— TC/RPOfficial title:
Phase I Clinical Trial of Intravitreal Injection of Autologous Bone Marrow Stem Cells in Patients With Retinitis Pigmentosa
Verified date | March 2017 |
Source | Red de Terapia Celular |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 8 |
Est. completion date | March 2017 |
Est. primary completion date | March 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Retinitis Pigmentosa bilateral diagnosis. - Visual acuity (measured with ETDRS) less than or equal to 20/70 and visual field below 30° central in both eyes. - Signed informed consent - Warranty sufficient adherence to protocol. It must fulfill all inclusion criteria. Exclusion Criteria: - Concurrence of any systemic or ocular disease that precludes or affects tracking study variables. Specifically retinal involvement with diabetes mellitus, glaucoma, macular degeneration or age. - Eye surgery in the previous 6 months. - Patients who are pregnant. - Patients with active lactation. - Physically fertile patients, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle or sexual orientation excludes sexual intercourse with a man and women whose partners have been sterilized by vasectomy or other methods, UNLESS tHEY are using a reliable contraceptive method. This birth control method can be: - Complete abstinence from sexual intercourse - Surgical sterilization (tubal ligation) - Surgical sterilization partner (vasectomy) - Implanted or injectable hormonal contraceptives and oral. - Patients with cardiac disease, renal, hepatic, systemic, immune that might influence the survival of patients during the test. - Positive serology for hepatitis B, hepatitis C or HIV. - Clinical criteria or anesthetics that contraindicate the sedation or the extraction of BM (Altered coagulation system or anticoagulated patient with inability to withdraw anticoagulation, hemodynamic instability, altered skin in the puncture site, etc.) - Participation in other clinical trials. - Inability to sign informed consent or understanding. |
Country | Name | City | State |
---|---|---|---|
Spain | Clinical Universitary Hospital Virgen de la Arrixaca | El Palmar | Murcia |
Lead Sponsor | Collaborator |
---|---|
Red de Terapia Celular | Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia, Hospital Universitario Virgen de la Arrixaca, Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca, Public Health Service, Murcia, Spanish National Health System |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | ||
Secondary | Quality of Life: Questionnaire VFQ-25 (Visual Function Questionnaire-25). | 12 months from baseline | ||
Secondary | Visual acuity (VA): Test ETDRS (Early Treatment Diabetic Retinopathy Study). | 12 months from baseline | ||
Secondary | Color Vision: Ishihara Color Test. | 12 months from baseline | ||
Secondary | Contrast sensitivity: CSV-1000E. | 12 months from baseline | ||
Secondary | Intraocular pressure (IOP): measured in mm Hg with applanation tonometer Haag Streit AT 900. | 12 months from baseline | ||
Secondary | Examination of the anterior and posterior pole: Made with biomicroscopy (BMC). | 12 months from baseline | ||
Secondary | 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 | ||
Secondary | Visual field (VF) and macular sensitivity (The Humphrey perimeter). | 12 months from baseline | ||
Secondary | Study eye fundus: Made by Retinography and Angiography fluorescein. | 12 months from baseline | ||
Secondary | Electrical retinal function: electroretinogram (ERG) (altered / unaltered). | 12 months from baseline | ||
Secondary | Visual evoked potentials with Pattern Reversal (VEP) (altered / no altered). | 12 months from baseline |
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