Clinical Trial of Intravitreal Injection of Autologous Bone Marrow Stem Cells in Patients With Retinitis Pigmentosa

Retinitis Pigmentosa Clinical Trial

— TC/RP  

Official title:

Phase I Clinical Trial of Intravitreal Injection of Autologous Bone Marrow Stem Cells in Patients With Retinitis Pigmentosa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02280135
• Other study ID #: TC/RP
• Secondary ID: 2012-000618-12
• Status: Completed
• Phase: Phase 1
• First received: October 22, 2014
• Last updated: March 29, 2017
• Start date: November 2014
• Est. completion date: March 2017

Study information

• Verified date: March 2017
• Source: Red de Terapia Celular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Retinitis
• Retinitis Pigmentosa

Intervention

Biological:
• Intravitreal injection of Autologous bone marrow Stem Cell
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.

Other:
• Subconjunctival injection of saline
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.

Locations

Country	Name	City	State
Spain	Clinical Universitary Hospital Virgen de la Arrixaca	El Palmar	Murcia

Sponsors (6)

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

Country where clinical trial is conducted

Spain, 

Outcome

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