Ignite Creation Date:
2025-12-24 @ 12:50 PM
Ignite Modification Date:
2026-02-13 @ 1:01 PM
Study NCT ID:
NCT03084861
Status:
TERMINATED
Last Update Posted:
2020-10-27
First Post:
2017-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Trial to Asses Efficacy and Safety of Cord Blood Eye Drops in Neurotrophic Keratopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'open label'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'whyStopped': 'Low recruitment. No safety issue associated.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-02-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-03-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-23', 'studyFirstSubmitDate': '2017-03-08', 'studyFirstSubmitQcDate': '2017-03-14', 'lastUpdatePostDateStruct': {'date': '2020-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Corneal lesion size', 'timeFrame': 'after 3 weeks post-treatment,', 'description': 'Variation percentage in corneal lesion size'}], 'secondaryOutcomes': [{'measure': 'Incidence of Adverse Events', 'timeFrame': 'From date of randomization until the date of the last visit (6 weeks post-treatment)', 'description': 'Safety evaluation through laboratory data and adverse events'}, {'measure': 'Corneal lesion size', 'timeFrame': 'at 2-3 days post-treatment and at 1, 2 and 6 weeks post-treatment', 'description': 'Variation percentage in corneal lesion size'}, {'measure': 'Stage on the corneal lesion', 'timeFrame': 'at 3 weeks post-treatment', 'description': 'Changes stage on the corneal lesion (cured, stage 1, stage 2, stage 3) from baseline'}, {'measure': 'Qualitative scale of corneal sensibility', 'timeFrame': 'at 2-3 days post-treatment and at 1, 2, 3 and 6 weeks post-treatment', 'description': 'Changes in qualitative scale of corneal sensibility (normoesthesia, hypoesthesia, anesthesia)'}, {'measure': 'Corneal opacity', 'timeFrame': 'at 2-3 days post-treatment and at 1, 2, 3 and 6 weeks post-treatment', 'description': 'Changes on corneal opacity from baseline (not response, improvement, worse)'}, {'measure': 'Visual acuity', 'timeFrame': 'at 2-3 days post-treatment and at 1, 2 and 6 weeks post-treatment', 'description': 'Line variation in relation to visual acuity'}, {'measure': 'Neurotrophic keratopathy', 'timeFrame': 'From date of randomization until the date of the last visit (6 weeks post-treatment)', 'description': 'Number of neurotrophic keratopathy complications'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neurotrophic Keratopathy']}, 'referencesModule': {'references': [{'pmid': '33085593', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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).\n\nAll 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.\n\nAfter signing informed consent, inclusion and exclusion criteria will be assessed, and if the patient meets all the requirements, the patient will be randomized.\n\nAfter 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 18 years old\n2. NK stage 2 or 3 (Mackie classification)\n3. Signed Informed Consent Form\n4. The patient is able to understand the nature of the study and to participate throughout its duration\n\nExclusion Criteria:\n\n1. Medical history of eye tumors\n2. Active eye infection\n3. Eyelid bad position or eyelid closure problems\n4. Conjunctiva scarring\n5. Topic chronic eye treatments with corticoids\n6. Acute corneal burns (\\<3 months)\n7. Intolerance to contact lens\n8. Allergy or inability to receive concomitant treatment with Exocin®\n9. Patients with immunosuppressive or chemotherapy treatment\n10. Pregnant woman or woman without proper contraceptive methods according to the investigator (\\*), or lactating women\n11. 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'}, 'identificationModule': {'nctId': 'NCT03084861', 'briefTitle': 'A Clinical Trial to Asses Efficacy and Safety of Cord Blood Eye Drops in Neurotrophic Keratopathy', 'organization': {'class': 'OTHER', 'fullName': 'Banc de Sang i Teixits'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'I.2016.010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'cord blood eye drops', 'description': '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', 'interventionNames': ['Drug: Cord Blood Eye Drops']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional treatment', 'description': 'Conventional treatment:\n\n1. 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\n2. 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', 'interventionNames': ['Drug: Conventional treatment']}], 'interventions': [{'name': 'Cord Blood Eye Drops', 'type': 'DRUG', 'description': 'Eye drops plasma from cord blood diluted v/v with Plasmalyte®, without antimicrobial preservatives', 'armGroupLabels': ['cord blood eye drops']}, {'name': 'Conventional treatment', 'type': 'DRUG', 'description': '1. Artificial tears: Lubristil ®\n2. Therapeutic Contact lens: Air Optix Night\\&Day', 'armGroupLabels': ['Conventional treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08916', 'city': 'Badalona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Universitari Germans Trias i Pujol', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}, {'zip': '08221', 'city': 'Terrassa', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Mútua de Terrassa', 'geoPoint': {'lat': 41.56667, 'lon': 2.01667}}, {'zip': '08026', 'city': 'Barcelona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Hospital de la Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08035', 'city': 'Barcelona', 'state': 'Catalonia', 'country': 'Spain', 'facility': "Hospital Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08017', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Instituto Oftalmológico Quirónsalud Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08024', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Hospital de l'Esperança", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Institut de microcirurgia ocular IMO', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic i Provincial de Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '17007', 'city': 'Girona', 'country': 'Spain', 'facility': 'Hospital Josep Trueta', 'geoPoint': {'lat': 41.98311, 'lon': 2.82493}}, {'zip': '43005', 'city': 'Tarragona', 'country': 'Spain', 'facility': 'Hospital Joan XXIII', 'geoPoint': {'lat': 41.11905, 'lon': 1.24544}}], 'overallOfficials': [{'name': 'Sergi Querol Giner, MD PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Banc de Sang i Teixits'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Banc de Sang i Teixits', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}