Low recruitment. No safety issue associated.
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
Sponsor study identifier
interventional
9
1 country
10
Study Start
February 24, 2017
Actual (reported)Primary Completion
March 12, 2020
Actual (reported)Study Completion
March 12, 2020
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 12, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 24, 2017
Actual (reported)March 8, 2017
Actual (reported)March 21, 2017
Actual (reported)March 12, 2020
Actual (reported)March 12, 2020
Actual (reported)Corneal lesion size
Variation percentage in corneal lesion size
after 3 weeks post-treatment,
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
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
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
Eye drops plasma from cord blood diluted v/v with Plasmalyte®, without antimicrobial preservatives
1. Artificial tears: Lubristil ® 2. Therapeutic Contact lens: Air Optix Night\&Day
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916, Spain
Hospital Mútua de Terrassa
Terrassa, Barcelona, 08221, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, 08026, Spain
Hospital Vall d'Hebron
Barcelona, Catalonia, 08035, Spain
Instituto Oftalmológico Quirónsalud Barcelona
Barcelona, 08017, Spain
Hospital de l'Esperança
Barcelona, 08024, Spain
Institut de microcirurgia ocular IMO
Barcelona, 08035, Spain
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.
Sergi Querol Giner, MD PHD
Banc de Sang i Teixits
9 participants (actual enrollment reported by the registry).
First Submitted
March 8, 2017
First Posted
March 21, 2017
Study Start
February 24, 2017
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Hospital Clinic i Provincial de Barcelona
Barcelona, 08036, Spain
Hospital Josep Trueta
Girona, 17007, Spain
Hospital Joan XXIII
Tarragona, 43005, Spain
Primary Completion
March 12, 2020
Actual (reported)Study Completion
March 12, 2020
Actual (reported)Last Updated
October 27, 2020
Record last verified: 2020-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: