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

• ClinicalTrials.gov Identifier: NCT03084861
• Recruitment Status: Terminated
• First Posted: March 21, 2017
• Last Update Posted: October 27, 2020
• Sponsor: Banc de Sang i Teixits
• Information provided by (Responsible Party): Banc de Sang i Teixits

Tracking Information

• First Submitted Date: March 8, 2017
• First Posted Date: March 21, 2017
• Last Update Posted Date: October 27, 2020
• Actual Study Start Date: February 24, 2017
• Actual Primary Completion Date: March 12, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 14, 2017)

Corneal lesion size [ Time Frame: after 3 weeks post-treatment, ]

Variation percentage in corneal lesion size

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Clinical Trial to Asses Efficacy and Safety of Cord Blood Eye Drops in Neurotrophic Keratopathy
• Official Title: 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: Interventional
• Study Phase: Phase 1; Phase 2

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

open label

Masking: None (Open Label)
Primary Purpose: Treatment

• Condition: Neurotrophic Keratopathy

Intervention

• 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

• 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.

Recruitment Information

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

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT03084861
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: Banc de Sang i Teixits
• Study Sponsor: Banc de Sang i Teixits
• Collaborators: Not Provided

Investigators

• Principal Investigator: Sergi Querol Giner, MD PHD; Banc de Sang i Teixits

• PRS Account: Banc de Sang i Teixits
• Verification Date: October 2020