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

Primary Purpose

Retinitis Pigmentosa

Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Intravitreal injection of Autologous bone marrow Stem Cell
Subconjunctival injection of saline
Sponsored by
Red de Terapia Celular
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinitis Pigmentosa

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Clinical Universitary Hospital Virgen de la Arrixaca

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intravitreal injection of Autologous bone marrow Stem Cell

Subconjunctival injection of saline

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Rate of serious and non-serious adverse events related with the use of bone marrow mononuclear cells in patients with retinitis pigmentosa

Secondary Outcome Measures

Quality of Life: Questionnaire VFQ-25 (Visual Function Questionnaire-25).
Visual acuity (VA): Test ETDRS (Early Treatment Diabetic Retinopathy Study).
Color Vision: Ishihara Color Test.
Contrast sensitivity: CSV-1000E.
Intraocular pressure (IOP): measured in mm Hg with applanation tonometer Haag Streit AT 900.
Examination of the anterior and posterior pole: Made with biomicroscopy (BMC).
Width of retinal macula layer and nerve fiber: Measured with Optical Coherence Tomography Spectral domain (OCT)(Topcon 3D OCT-2000 Spectral Domain OCT).
Visual field (VF) and macular sensitivity (The Humphrey perimeter).
Study eye fundus: Made by Retinography and Angiography fluorescein.
Electrical retinal function: electroretinogram (ERG) (altered / unaltered).
Visual evoked potentials with Pattern Reversal (VEP) (altered / no altered).

Full Information

First Posted
October 22, 2014
Last Updated
March 29, 2017
Sponsor
Red de Terapia Celular
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
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1. Study Identification

Unique Protocol Identification Number
NCT02280135
Brief Title
Clinical Trial of Intravitreal Injection of Autologous Bone Marrow Stem Cells in Patients With Retinitis Pigmentosa
Acronym
TC/RP
Official Title
Phase I Clinical Trial of Intravitreal Injection of Autologous Bone Marrow Stem Cells in Patients With Retinitis Pigmentosa
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Red de Terapia Celular
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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinitis Pigmentosa

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intravitreal injection of Autologous bone marrow Stem Cell
Arm Type
Experimental
Arm Description
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.
Arm Title
Subconjunctival injection of saline
Arm Type
Placebo Comparator
Arm Description
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 Type
Biological
Intervention Name(s)
Intravitreal injection of Autologous bone marrow Stem Cell
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Subconjunctival injection of saline
Intervention Description
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 Outcome Measure Information:
Title
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 Measure Information:
Title
Quality of Life: Questionnaire VFQ-25 (Visual Function Questionnaire-25).
Time Frame
12 months from baseline
Title
Visual acuity (VA): Test ETDRS (Early Treatment Diabetic Retinopathy Study).
Time Frame
12 months from baseline
Title
Color Vision: Ishihara Color Test.
Time Frame
12 months from baseline
Title
Contrast sensitivity: CSV-1000E.
Time Frame
12 months from baseline
Title
Intraocular pressure (IOP): measured in mm Hg with applanation tonometer Haag Streit AT 900.
Time Frame
12 months from baseline
Title
Examination of the anterior and posterior pole: Made with biomicroscopy (BMC).
Time Frame
12 months from baseline
Title
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
Title
Visual field (VF) and macular sensitivity (The Humphrey perimeter).
Time Frame
12 months from baseline
Title
Study eye fundus: Made by Retinography and Angiography fluorescein.
Time Frame
12 months from baseline
Title
Electrical retinal function: electroretinogram (ERG) (altered / unaltered).
Time Frame
12 months from baseline
Title
Visual evoked potentials with Pattern Reversal (VEP) (altered / no altered).
Time Frame
12 months from baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
María Elena Rodriguez González-Herrero, MD
Organizational Affiliation
Hospital Universitario Virgen de la Arrixaca
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Universitary Hospital Virgen de la Arrixaca
City
El Palmar
State/Province
Murcia
ZIP/Postal Code
30120
Country
Spain

12. IPD Sharing Statement

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

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