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

NCT03084861 | Terminated Phase 1

• 1 other identifier: I.2016.010
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 10

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).

Conditions

Neurotrophic Keratopathy

Outcome Measures

Primary Outcomes (1)

• Corneal lesion size

  Variation percentage in corneal lesion size

  after 3 weeks post-treatment,

Secondary Outcomes (7)

• Incidence of Adverse Events

  From date of randomization until the date of the last visit (6 weeks post-treatment)

• Corneal lesion size

  at 2-3 days post-treatment and at 1, 2 and 6 weeks post-treatment

• Stage on the corneal lesion

  at 3 weeks post-treatment

• Qualitative scale of corneal sensibility

  at 2-3 days post-treatment and at 1, 2, 3 and 6 weeks post-treatment

• Corneal opacity

  at 2-3 days post-treatment and at 1, 2, 3 and 6 weeks post-treatment

Study Arms (2)

cord blood eye drops

EXPERIMENTAL

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

Drug: Cord Blood Eye Drops

Conventional treatment

ACTIVE COMPARATOR

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

Drug: Conventional treatment

Interventions

Cord Blood Eye Drops DRUG

Eye drops plasma from cord blood diluted v/v with Plasmalyte®, without antimicrobial preservatives

cord blood eye drops

Conventional treatment DRUG

1. Artificial tears: Lubristil ® 2. Therapeutic Contact lens: Air Optix Night\&Day

Conventional treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Medical history of eye tumors
• Active eye infection
• Eyelid bad position or eyelid closure problems
• Conjunctiva scarring
• Topic chronic eye treatments with corticoids
• Acute corneal burns (\<3 months)
• Intolerance to contact lens
• Allergy or inability to receive concomitant treatment with Exocin®
• Patients with immunosuppressive or chemotherapy treatment
• Pregnant woman or woman without proper contraceptive methods according to the investigator (\*), or lactating women
• 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

Sponsors & Collaborators

• Banc de Sang i Teixits: lead

Study Sites (10)

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital Mútua de Terrassa

Terrassa, Barcelona, 08221, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia, 08026, Spain

Location

Hospital Vall d'Hebron

Barcelona, Catalonia, 08035, Spain

Location

Instituto Oftalmológico Quirónsalud Barcelona

Barcelona, 08017, Spain

Location

Hospital de l'Esperança

Barcelona, 08024, Spain

Location

Institut de microcirurgia ocular IMO

Barcelona, 08035, Spain

Location

Hospital Clinic i Provincial de Barcelona

Barcelona, 08036, Spain

Location

Hospital Josep Trueta

Girona, 17007, Spain

Location

Hospital Joan XXIII

Tarragona, 43005, Spain

Location

Related Publications (1)

• 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.

  PMID: 33085593 DERIVED

Study Officials

• Sergi Querol Giner, MD PHD

  Banc de Sang i Teixits

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: open label

Study Record Dates

• First Submitted: March 8, 2017
• First Posted: March 21, 2017
• Study Start: February 24, 2017
• Primary Completion: March 12, 2020
• Study Completion: March 12, 2020
• Last Updated: October 27, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (10)