Clinical evaluation of allogeneic eye drops from cord blood platelet lysate
Por:
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 Grp
Publicada:
1 jul 2021
Resumen:
Background - Current treatments for several corneal lesions show limited efficacy. Here we report the clinical evaluation of the efficacy of a novel eye drop preparation produced in a public cord blood (CB) bank.
Materials and methods - In a multicentre, retrospective, consecutive case study we evaluated 33 patients (46 eyes) unresponsive to conventional treatments who required urgent intervention. The patients were given allogeneic eye drops obtained from cord blood platelet lysate (CBED) to treat severe ocular surface lesions under a compassionate use protocol. The CBED were prepared from CB units donated for haematopoietic stem cell transplantation that did not contain the minimum stem cell dose required for this use. Patients were grouped by acute conditions (neurotrophic ulcers: group I; other corneal ulcers: group II; corneal burns: group III), and chronic conditions (ocular graft-versus-host disease: group IV; severe dry eye syndrome: group V). The patients received one or two drops of the product to the affected eye four to six times per day for 19 days. A further 19-day cycle of treatment could be repeated according to the initial clinical response.
Results - Patients received a median of 19 CBED vials (interquartile range 19-57, range 19-442) to complete the therapy. Group I-II-III patients showed full and partial ulcer recovery in 25 (78%) and six (19%) eyes respectively. One eye (3%) did not respond to treatment. For groups IV-V improvement was reported for 12 (85%) eyes and lesions worsened on treatment in both eyes (15%) of one patient. No severe adverse events were directly attributed to CBED.
Discussion - Promptly available CBED resulted in a well-tolerated allogeneic treatment that showed evidence of efficacy in this cohort of patients. These positive results support further studies on CBED from platelet lysate as a novel product of CB banks. A prospective clinical trial in neurotrophic keratitis (NCT03084861) is ongoing to confirm these preliminary data.
Filiaciones:
Samarkanova, D:
Blood & Tissue Bank BST, Barcelona, Spain
Vall dHebron Res Inst VHIR, Transfus Med Res Grp, Barcelona, Spain
Autonomous Univ Barcelona UAB, Dept Med, Barcelona, Spain
Martin, S:
Vall dHebron Univ Hosp, Dept Ophthalmol, Barcelona, Spain
Bisbe, L:
Vall dHebron Univ Hosp, Dept Ophthalmol, Barcelona, Spain
Puig, J:
Vall dHebron Univ Hosp, Dept Ophthalmol, Barcelona, Spain
Calatayud-Pinuaga, M:
Vall dHebron Univ Hosp, Dept Ophthalmol, Barcelona, Spain
Quironsalud Cataract & Lasik Eye Surg Hosp Dubai, Dubai, U Arab Emirates
Rodriguez, L:
Blood & Tissue Bank BST, Barcelona, Spain
Vall dHebron Res Inst VHIR, Transfus Med Res Grp, Barcelona, Spain
Azqueta, C:
Blood & Tissue Bank BST, Barcelona, Spain
Coll, R:
Blood & Tissue Bank BST, Barcelona, Spain
Casaroli-Marano, R:
Blood & Tissue Bank BST, Barcelona, Spain
Univ Barcelona, Sch Med, Dept Surg, Barcelona, Spain
Univ Barcelona, Hosp Clin Barcelona, Barcelona, Spain
Madrigal, A:
Blood & Tissue Bank BST, Barcelona, Spain
Anthony Nolan Res Inst, London, England
Rebulla, P:
Fdn Ca Granda Osped Maggiore Policlin, IRCCS, Dept Transfus Med & Haematol, Milan, Italy
Querol, S:
Blood & Tissue Bank BST, Barcelona, Spain
Vall dHebron Res Inst VHIR, Transfus Med Res Grp, Barcelona, Spain
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