Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Clinical Trial to Asses Efficacy and Safety of Cord Blood Eye Drops in Neurotrophic Keratopathy

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: NCT03084861
Recruitment Status : Terminated (Low recruitment. No safety issue associated.)
First Posted : March 21, 2017
Last Update Posted : October 27, 2020
Sponsor:
Information provided by (Responsible Party):
Banc de Sang i Teixits

Tracking Information
First Submitted Date  ICMJE March 8, 2017
First Posted Date  ICMJE March 21, 2017
Last Update Posted Date October 27, 2020
Actual Study Start Date  ICMJE February 24, 2017
Actual Primary Completion Date March 12, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 14, 2017)
Corneal lesion size [ Time Frame: after 3 weeks post-treatment, ]
Variation percentage in corneal lesion size
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2017)
  • Incidence of Adverse Events [ Time Frame: From date of randomization until the date of the last visit (6 weeks post-treatment) ]
    Safety evaluation through laboratory data and adverse events
  • Corneal lesion size [ Time Frame: at 2-3 days post-treatment and at 1, 2 and 6 weeks post-treatment ]
    Variation percentage in corneal lesion size
  • Stage on the corneal lesion [ Time Frame: at 3 weeks post-treatment ]
    Changes stage on the corneal lesion (cured, stage 1, stage 2, stage 3) from baseline
  • Qualitative scale of corneal sensibility [ Time Frame: at 2-3 days post-treatment and at 1, 2, 3 and 6 weeks post-treatment ]
    Changes in qualitative scale of corneal sensibility (normoesthesia, hypoesthesia, anesthesia)
  • Corneal opacity [ Time Frame: at 2-3 days post-treatment and at 1, 2, 3 and 6 weeks post-treatment ]
    Changes on corneal opacity from baseline (not response, improvement, worse)
  • Visual acuity [ Time Frame: at 2-3 days post-treatment and at 1, 2 and 6 weeks post-treatment ]
    Line variation in relation to visual acuity
  • Neurotrophic keratopathy [ Time Frame: From date of randomization until the date of the last visit (6 weeks post-treatment) ]
    Number of neurotrophic keratopathy complications
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 A Clinical Trial to Asses Efficacy and Safety of Cord Blood Eye Drops in Neurotrophic Keratopathy
Official Title  ICMJE A Multicenter, Randomized, Open-label, Two-arms Phase I/II Clinical Trial to Asses Efficacy and Safety of Cord Blood Eye Drops in Neurotrophic Keratopathy
Brief Summary This is a multicenter, randomized, open-label, two-arms phase I/II, clinical trial, in which 42 patients will be enrolled with the principal objective to evaluate the efficacy through changes in lesion size and, secondary, to evaluate the safety and efficacy through corneal sensibility, corneal opacity, visual acuity and complications of Neurotrophic Keratopathy (NK). Patients will be randomized 1:1 to receive experimental treatment (cord blood eye drops) or conventional treatment (artificial tears and therapeutic contact lens).
Detailed Description

This is a multicenter, randomized, open-label, two-arms phase I/II, clinical trial, in which 42 patients will be enrolled with the principal objective to evaluate the efficacy through changes in lesion size and, secondary, to evaluate the safety and efficacy through corneal sensibility, corneal opacity, visual acuity and complications of NK. Patients will be randomized 1:1 to receive experimental treatment (cord blood eye drops) or conventional treatment (artificial tears and therapeutic contact lens).

All patients, with conventional or experimental treatment, will be treated for 19 days. A topical antibiotic will be added too as a concomitant treatment to all treatment groups, until the injury closes or according to medical criteria.

After signing informed consent, inclusion and exclusion criteria will be assessed, and if the patient meets all the requirements, the patient will be randomized.

After initiation of the treatment, patients will be follow-up at 2-3 days and once a week for 3 weeks. A final follow-up is planned at 6 weeks.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
open label
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neurotrophic Keratopathy
Intervention  ICMJE
  • Drug: Cord Blood Eye Drops
    Eye drops plasma from cord blood diluted v/v with Plasmalyte®, without antimicrobial preservatives
  • Drug: Conventional treatment
    1. Artificial tears: Lubristil ®
    2. Therapeutic Contact lens: Air Optix Night&Day
Study Arms  ICMJE
  • Experimental: cord blood eye drops
    Experimental drug: cord blood eye drops Description: eye drops plasma from cord blood diluted v/v with Plasmalyte®, without antimicrobial preservatives Dosage regimen: 1 drop every 2 hours Pharmaceutical form: ophthalmic preparation eye drops Presentation: batch of 19 vials of 1 mL per vial Route of administration: ophthalmic/ocular
    Intervention: Drug: Cord Blood Eye Drops
  • Active Comparator: Conventional treatment

    Conventional treatment:

    1. Artificial tears Description: Lubristil ® (single dose) Dosage regimen: 1 drop every 2 hours Pharmaceutical form: ophthalmic preparation eye drops Presentation: batch of 20 or 30 vials of 0.3 mL per vial Route of administration: ophthalmic
    2. Therapeutic Contact lens Description: Air Optix Night&Day Dosage regimen: 1 contact lens per visit Pharmaceutical form: contact lens Presentation: 1 unit per case Route of administration: ophthalmic/ocular
    Intervention: Drug: Conventional treatment
Publications * Samarkanova D, Martin S, Bisbe L, Puig J, Calatayud-Pinuaga M, Rodriguez L, Azqueta C, Coll R, Casaroli-Marano R, Madrigal A, Rebulla P, Querol S; Barcelona CBED Study Group (Appendix I). Clinical evaluation of allogeneic eye drops from cord blood platelet lysate. Blood Transfus. 2021 Jul;19(4):347-356. doi: 10.2450/2020.0130-20. Epub 2020 Oct 9.

*   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 Terminated
Actual Enrollment  ICMJE
 (submitted: October 23, 2020)
9
Original Estimated Enrollment  ICMJE
 (submitted: March 14, 2017)
42
Actual Study Completion Date  ICMJE March 12, 2020
Actual Primary Completion Date March 12, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age ≥ 18 years old
  2. NK stage 2 or 3 (Mackie classification)
  3. Signed Informed Consent Form
  4. The patient is able to understand the nature of the study and to participate throughout its duration

Exclusion Criteria:

  1. Medical history of eye tumors
  2. Active eye infection
  3. Eyelid bad position or eyelid closure problems
  4. Conjunctiva scarring
  5. Topic chronic eye treatments with corticoids
  6. Acute corneal burns (<3 months)
  7. Intolerance to contact lens
  8. Allergy or inability to receive concomitant treatment with Exocin®
  9. Patients with immunosuppressive or chemotherapy treatment
  10. Pregnant woman or woman without proper contraceptive methods according to the investigator (*), or lactating women
  11. Participation in another clinical trial in the last month (*) Contraceptive methods accepted in the protocol are: hormonal, intrauterine device (IUD), barrier methods, voluntary sterilization or the patient has menopause >1 year duration
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 NCT03084861
Other Study ID Numbers  ICMJE I.2016.010
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Banc de Sang i Teixits
Study Sponsor  ICMJE Banc de Sang i Teixits
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sergi Querol Giner, MD PHD Banc de Sang i Teixits
PRS Account Banc de Sang i Teixits
Verification Date October 2020

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