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

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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

Tracking Information
First Submitted Date  ICMJE October 22, 2014
First Posted Date  ICMJE October 31, 2014
Last Update Posted Date March 30, 2017
Study Start Date  ICMJE November 2014
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 29, 2014)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 29, 2014)
  • Quality of Life: Questionnaire VFQ-25 (Visual Function Questionnaire-25). [ Time Frame: 12 months from baseline ]
  • Visual acuity (VA): Test ETDRS (Early Treatment Diabetic Retinopathy Study). [ Time Frame: 12 months from baseline ]
  • Color Vision: Ishihara Color Test. [ Time Frame: 12 months from baseline ]
  • Contrast sensitivity: CSV-1000E. [ 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 ]
  • 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 ]
  • Visual field (VF) and macular sensitivity (The Humphrey perimeter). [ Time Frame: 12 months from baseline ]
  • Study eye fundus: Made by Retinography and Angiography fluorescein. [ Time Frame: 12 months from baseline ]
  • Electrical retinal function: electroretinogram (ERG) (altered / unaltered). [ Time Frame: 12 months from baseline ]
  • Visual evoked potentials with Pattern Reversal (VEP) (altered / no altered). [ Time Frame: 12 months from baseline ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial of Intravitreal Injection of Autologous Bone Marrow Stem Cells in Patients With Retinitis Pigmentosa
Official Title  ICMJE Phase I Clinical Trial of Intravitreal Injection of Autologous Bone Marrow Stem Cells in Patients With Retinitis Pigmentosa
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Retinitis Pigmentosa
Intervention  ICMJE
  • 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.

  • 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.

Study Arms  ICMJE
  • 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.

    Intervention: Biological: Intravitreal injection of Autologous bone marrow Stem Cell
  • 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.
    Intervention: Other: Subconjunctival injection of saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 29, 2017)
8
Original Estimated Enrollment  ICMJE
 (submitted: October 29, 2014)
10
Actual Study Completion Date  ICMJE March 2017
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02280135
Other Study ID Numbers  ICMJE TC/RP
2012-000618-12 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Red de Terapia Celular
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Red de Terapia Celular
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • 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  ICMJE
Principal Investigator: María Elena Rodriguez González-Herrero, MD Hospital Universitario Virgen de la Arrixaca
PRS Account Red de Terapia Celular
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP