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Completed

NCT Number: NCT02280135

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.

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Key information

Conditions

Retinitis Pigmentosa Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Retinal Degeneration Retinal Diseases Retinal Dystrophies

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Universitary Hospital Virgen de la Arrixaca

El Palmar, Murcia, 30120, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intravitreal injection of Autologous bone marrow Stem Cell

Biological

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.

Subconjunctival injection of saline

Other

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Red de Terapia Celular

Industry

Collaborators

  • 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
  • Spanish National Health System

Registry information

Official study title

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

Acronym: TC/RP

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Oct 31, 2014
Registry last updated
Mar 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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