Status:
COMPLETED
Clinical Trial of Intravitreal Injection of Autologous Bone Marrow Stem Cells in Patients With Retinitis Pigmentosa
Lead Sponsor:
Red de Terapia Celular
Collaborating Sponsors:
Spanish National Health System
Hospital Universitario Virgen de la Arrixaca
Conditions:
Retinitis Pigmentosa
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
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, pa...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2017
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT02280135
Start Date
November 1 2014
End Date
March 1 2017
Last Update
March 30 2017
Active Locations (1)
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1
Clinical Universitary Hospital Virgen de la Arrixaca
El Palmar, Murcia, Spain, 30120