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Clinical Trial of Intravitreal Injection of Autologous Bone Marrow Stem Cells in Patients With Retinitis Pigmentosa (TC/RP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02280135
Recruitment Status : Completed
First Posted : October 31, 2014
Last Update Posted : March 30, 2017
Sponsor:
Collaborators:
Spanish National Health System
Hospital Universitario Virgen de la Arrixaca
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Public Health Service, Murcia
Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca
Information provided by (Responsible Party):
Red de Terapia Celular

Study Description
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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, parallel, double-blind, phase I placebo-controlled clinical trial.

Condition or disease Intervention/treatment Phase
Retinitis Pigmentosa Biological: Intravitreal injection of Autologous bone marrow Stem Cell Other: Subconjunctival injection of saline Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase I Clinical Trial of Intravitreal Injection of Autologous Bone Marrow Stem Cells in Patients With Retinitis Pigmentosa
Study Start Date : November 2014
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Intravitreal injection of Autologous bone marrow Stem Cell

Patients included in the trial will receive a pars plana intravitreal injection of autologous mononuclear cells (MNC) of bone marrow (BM) in one eye (experimental group A or group). The eye in which autologous BM MNCs were injected will be determined randomly.

The average dose will be 30 million of cells (5-60 million) diluted in 0.1 ml. of saline.

 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.
Placebo Comparator: Subconjunctival injection of saline
Patients included in the trial will receive a subconjunctival injection of 0.1 ml of saline (SF) (placebo) in the fellow eye (group B or control group). In this way the patient will receive an injection in the control eye but avoid the risks of intraocular injection.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. Quality of Life: Questionnaire VFQ-25 (Visual Function Questionnaire-25). [ Time Frame: 12 months from baseline ]
  2. Visual acuity (VA): Test ETDRS (Early Treatment Diabetic Retinopathy Study). [ Time Frame: 12 months from baseline ]
  3. Color Vision: Ishihara Color Test. [ Time Frame: 12 months from baseline ]
  4. Contrast sensitivity: CSV-1000E. [ Time Frame: 12 months from baseline ]
  5. Intraocular pressure (IOP): measured in mm Hg with applanation tonometer Haag Streit AT 900. [ Time Frame: 12 months from baseline ]
  6. Examination of the anterior and posterior pole: Made with biomicroscopy (BMC). [ Time Frame: 12 months from baseline ]
  7. 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 ]
  8. Visual field (VF) and macular sensitivity (The Humphrey perimeter). [ Time Frame: 12 months from baseline ]
  9. Study eye fundus: Made by Retinography and Angiography fluorescein. [ Time Frame: 12 months from baseline ]
  10. Electrical retinal function: electroretinogram (ERG) (altered / unaltered). [ Time Frame: 12 months from baseline ]
  11. Visual evoked potentials with Pattern Reversal (VEP) (altered / no altered). [ Time Frame: 12 months from baseline ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02280135


Locations
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Spain
Clinical Universitary Hospital Virgen de la Arrixaca
El Palmar, Murcia, Spain, 30120
Sponsors and Collaborators
Red de Terapia Celular
Spanish National Health System
Hospital Universitario Virgen de la Arrixaca
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Public Health Service, Murcia
Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca
Investigators
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Principal Investigator: María Elena Rodriguez González-Herrero, MD Hospital Universitario Virgen de la Arrixaca
More Information
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Responsible Party: Red de Terapia Celular
ClinicalTrials.gov Identifier: NCT02280135    
Other Study ID Numbers: TC/RP
2012-000618-12 ( EudraCT Number )
First Posted: October 31, 2014    Key Record Dates
Last Update Posted: March 30, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Retinitis
Retinitis Pigmentosa
Retinal Diseases
Eye Diseases
 Eye Diseases, Hereditary
Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn