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Low recruitment. No safety issue associated.
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Conventional treatment | Active Comparator | Conventional treatment:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cord Blood Eye Drops | Drug | Eye drops plasma from cord blood diluted v/v with Plasmalyte®, without antimicrobial preservatives |
|
| Measure | Description | Time Frame |
|---|---|---|
| Corneal lesion size | Variation percentage in corneal lesion size | after 3 weeks post-treatment, |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events | Safety evaluation through laboratory data and adverse events | From date of randomization until the date of the last visit (6 weeks post-treatment) |
| Corneal lesion size |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sergi Querol Giner, MD PHD | Banc de Sang i Teixits | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Germans Trias i Pujol | Badalona | Barcelona | 08916 | Spain | ||
| Hospital Mútua de Terrassa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33085593 | Derived | 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. |
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open label
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| Conventional treatment | Drug |
|
|
Variation percentage in corneal lesion size
| at 2-3 days post-treatment and at 1, 2 and 6 weeks post-treatment |
| Stage on the corneal lesion | Changes stage on the corneal lesion (cured, stage 1, stage 2, stage 3) from baseline | at 3 weeks post-treatment |
| Qualitative scale of corneal sensibility | Changes in qualitative scale of corneal sensibility (normoesthesia, hypoesthesia, anesthesia) | at 2-3 days post-treatment and at 1, 2, 3 and 6 weeks post-treatment |
| Corneal opacity | Changes on corneal opacity from baseline (not response, improvement, worse) | at 2-3 days post-treatment and at 1, 2, 3 and 6 weeks post-treatment |
| Visual acuity | Line variation in relation to visual acuity | at 2-3 days post-treatment and at 1, 2 and 6 weeks post-treatment |
| Neurotrophic keratopathy | Number of neurotrophic keratopathy complications | From date of randomization until the date of the last visit (6 weeks post-treatment) |
| 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 |
| Hospital Clinic i Provincial de Barcelona | Barcelona | 08036 | Spain |
| Hospital Josep Trueta | Girona | 17007 | Spain |
| Hospital Joan XXIII | Tarragona | 43005 | Spain |