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

Red de Terapia Celular8 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Retinitis Pigmentosa

Interventions

Intravitreal injection of Autologous bone marrow Stem CellBIOLOGICAL

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.

Subconjunctival injection of salineOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Clinical Universitary Hospital Virgen de la Arrixaca

El Palmar, Murcia, Spain

Outcomes

Primary Outcomes

Rate of serious and non-serious adverse events related with the use of bone marrow mononuclear cells in patients with retinitis pigmentosa