Clinical trial NCT02280135: Clinical Trial of Intravitreal Injection of Autologous Bone Marrow Stem Cells in Patients With Retinitis Pigmentosa
Official title: Phase I Clinical Trial of Intravitreal Injection of Autologous Bone Marrow Stem Cells in Patients With Retinitis Pigmentosa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Retinitis Pigmentosa
Lead sponsor: Red de Terapia Celular
Sponsor class: INDUSTRY
Collaborators: name: Spanish National Health System
name: Hospital Universitario Virgen de la Arrixaca
name: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
name: Public Health Service, Murcia
name: Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca
First posted: 2014-10-31
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Rate of serious and non-serious adverse events related with the use of bone marrow mononuclear cells in patients with retinitis pigmentosa
timeFrame: 12 months from baseline
Secondary outcomes:
measure: Quality of Life: Questionnaire VFQ-25 (Visual Function Questionnaire-25).
timeFrame: 12 months from baseline
measure: Visual acuity (VA): Test ETDRS (Early Treatment Diabetic Retinopathy Study).
timeFrame: 12 months from baseline
measure: Color Vision: Ishihara Color Test.
timeFrame: 12 months from baseline
measure: Contrast sensitivity: CSV-1000E.
timeFrame: 12 months from baseline
measure: Intraocular pressure (IOP): measured in mm Hg with applanation tonometer Haag Streit AT 900.
timeFrame: 12 months from baseline
measure: Examination of the anterior and posterior pole: Made with biomicroscopy (BMC).
timeFrame: 12 months from baseline
measure: Width of retinal macula layer and nerve fiber: Measured with Optical Coherence Tomography Spectral domain (OCT)(Topcon 3D OCT-2000 Spectral Domain OCT).
timeFrame: 12 months from baseline
measure: Visual field (VF) and macular sensitivity (The Humphrey perimeter).
timeFrame: 12 months from baseline
measure: Study eye fundus: Made by Retinography and Angiography fluorescein.
timeFrame: 12 months from baseline
measure: Electrical retinal function: electroretinogram (ERG) (altered / unaltered).
timeFrame: 12 months from baseline
measure: Visual evoked potentials with Pattern Reversal (VEP) (altered / no altered).
timeFrame: 12 months from baseline
Other outcomes:
Locations:
city: El Palmar
country: Spain
facility: Clinical Universitary Hospital Virgen de la Arrixaca
state: Murcia
Study officials:
affiliation: Hospital Universitario Virgen de la Arrixaca
name: María Elena Rodriguez González-Herrero, MD
role: PRINCIPAL_INVESTIGATOR
References: