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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02280135
• Date of registration: 22/10/2014
• Prospective Registration: Yes
• Primary sponsor: Red de Terapia Celular
• Public title: Clinical Trial of Intravitreal Injection of Autologous Bone Marrow Stem Cells in Patients With Retinitis Pigmentosa TC/RP
• Scientific title: Phase I Clinical Trial of Intravitreal Injection of Autologous Bone Marrow Stem Cells in Patients With Retinitis Pigmentosa
• Date of first enrolment: November 2014
• Target sample size: 8
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02280135
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 1

Countries of recruitment

Spain

Contacts

• Name: María Elena Rodriguez González-Herrero, MD
• Affiliation: Hospital Universitario Virgen de la Arrixaca

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Retinitis Pigmentosa

Intervention(s)

Biological: Intravitreal injection of Autologous bone marrow Stem Cell

Other: Subconjunctival injection of saline

Primary Outcome(s)

Rate of serious and non-serious adverse events related with the use of bone marrow mononuclear cells in patients with retinitis pigmentosa [Time Frame: 12 months from baseline]

Secondary Outcome(s)

Electrical retinal function: electroretinogram (ERG) (altered / unaltered). [Time Frame: 12 months from baseline]

Examination of the anterior and posterior pole: Made with biomicroscopy (BMC). [Time Frame: 12 months from baseline]

Width of retinal macula layer and nerve fiber: Measured with Optical Coherence Tomography Spectral domain (OCT)(Topcon 3D OCT-2000 Spectral Domain OCT). [Time Frame: 12 months from baseline]

Study eye fundus: Made by Retinography and Angiography fluorescein. [Time Frame: 12 months from baseline]

Visual field (VF) and macular sensitivity (The Humphrey perimeter). [Time Frame: 12 months from baseline]

Intraocular pressure (IOP): measured in mm Hg with applanation tonometer Haag Streit AT 900. [Time Frame: 12 months from baseline]

Visual evoked potentials with Pattern Reversal (VEP) (altered / no altered). [Time Frame: 12 months from baseline]

Contrast sensitivity: CSV-1000E. [Time Frame: 12 months from baseline]

Quality of Life: Questionnaire VFQ-25 (Visual Function Questionnaire-25). [Time Frame: 12 months from baseline]

Color Vision: Ishihara Color Test. [Time Frame: 12 months from baseline]

Visual acuity (VA): Test ETDRS (Early Treatment Diabetic Retinopathy Study). [Time Frame: 12 months from baseline]

Secondary ID(s)

2012-000618-12

TC/RP

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Spanish National Health System

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