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

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

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.

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.