A Clinical Trial to Asses Efficacy and Safety of Cord Blood Eye Drops in Neurotrophic Keratopathy
NCT ID: NCT03084861
Last Updated: 2020-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1/PHASE2
9 participants
INTERVENTIONAL
2017-02-24
2020-03-12
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
Cord Blood Eye Drops
Eye drops plasma from cord blood diluted v/v with Plasmalyte®, without antimicrobial preservatives
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
Conventional treatment
1. Artificial tears: Lubristil ®
2. Therapeutic Contact lens: Air Optix Night\&Day
Interventions
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Cord Blood Eye Drops
Eye drops plasma from cord blood diluted v/v with Plasmalyte®, without antimicrobial preservatives
Conventional treatment
1. Artificial tears: Lubristil ®
2. Therapeutic Contact lens: Air Optix Night\&Day
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Banc de Sang i Teixits
OTHER
Responsible Party
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Principal Investigators
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Sergi Querol Giner, MD PHD
Role: PRINCIPAL_INVESTIGATOR
Banc de Sang i Teixits
Locations
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Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Mútua de Terrassa
Terrassa, Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, Spain
Hospital Vall d'Hebron
Barcelona, Catalonia, Spain
Instituto Oftalmológico Quirónsalud Barcelona
Barcelona, , Spain
Hospital de l'Esperança
Barcelona, , Spain
Institut de microcirurgia ocular IMO
Barcelona, , Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, , Spain
Hospital Josep Trueta
Girona, , Spain
Hospital Joan XXIII
Tarragona, , Spain
Countries
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References
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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.
Other Identifiers
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I.2016.010
Identifier Type: -
Identifier Source: org_study_id