Blood derived treatment from two allogeneic sources for severe dry eye associated to keratopathy: A multicentre randomised cross over clinical trial

Emilio Campos, Piera Versura, Marina Buzzi, Luigi Fontana, Giuseppe Giannaccare, Marco Pellegrini, Nico Lanconelli, Alessandra Brancaleoni, Fabiana Moscardelli, Stefano Sebastiani, Cristiana Vaselli, Vanda Randi

Research output: Contribution to journalArticle

Abstract

Aim: To compare the efficacy of cord blood and peripheral adult donor blood serum eyedrops, controlled for growth factor content, in the treatment of severe dry eye diseases (DED) resistant to conventional therapy. Methods: This was a multicentre randomised, double-masked, cross-over clinical trial. Sixty patients diagnosed as severe DED, associated to persistent corneal epithelial defects were randomised and equally assigned to group A (treated with cord blood serum (CBS)) or group B (treated with PBS), eyedrops administered eight times/day for 1 month. Primary outcome was the pretreatment and post-treatment change in corneal fluorescein staining. Secondary outcomes included the pretreatment and post-treatment change in Ocular Surface Disease Index (OSDI) questionnaire and Visual Analogue Score (VAS) of subjective symptoms, Schirmer I test, tear break-up time and conjunctival staining. Patients with relapse in signs or symptoms after further 2 months switched to the remaining group for one additional month. Data were statistically analysed (p<0.05). Results: Corneal staining was more significantly reduced after the CBS treatment, both VAS and OSDI score reduction was observed in both groups, but group A reported significantly less grittiness and pain. Nineteen patients shifted in the crossover period, the within individual comparison confirmed a better recovery in the CBS treatment period. Reduction in epithelial damage was positively associated with epidermal growth factor, transforming growth factorα and platelet-derived growth factor content. Levels of interleukins (IL-13) were positively associated with symptom decrease. Conclusions: Overall, DED signs improved after both CBS and PBS treatments, with potential advantages of CBS for subjective symptoms and corneal damage reduction.

Original languageEnglish
Article number314859
JournalBritish Journal of Ophthalmology
DOIs
Publication statusAccepted/In press - Jan 1 2019

Fingerprint

Cross-Over Studies
Fetal Blood
Eye Diseases
Clinical Trials
Serum
Interleukin-13
Ophthalmic Solutions
Staining and Labeling
Therapeutics
Platelet-Derived Growth Factor
Transforming Growth Factors
Blood Group Antigens
Fluorescein
Tears
Epidermal Growth Factor
Signs and Symptoms
Intercellular Signaling Peptides and Proteins
Tissue Donors
Recurrence
Pain

Keywords

  • clinical trial
  • cornea
  • ocular surface
  • wound healing

ASJC Scopus subject areas

  • Ophthalmology
  • Sensory Systems
  • Cellular and Molecular Neuroscience

Cite this

Blood derived treatment from two allogeneic sources for severe dry eye associated to keratopathy : A multicentre randomised cross over clinical trial. / Campos, Emilio; Versura, Piera; Buzzi, Marina; Fontana, Luigi; Giannaccare, Giuseppe; Pellegrini, Marco; Lanconelli, Nico; Brancaleoni, Alessandra; Moscardelli, Fabiana; Sebastiani, Stefano; Vaselli, Cristiana; Randi, Vanda.

In: British Journal of Ophthalmology, 01.01.2019.

Research output: Contribution to journalArticle

Campos, E, Versura, P, Buzzi, M, Fontana, L, Giannaccare, G, Pellegrini, M, Lanconelli, N, Brancaleoni, A, Moscardelli, F, Sebastiani, S, Vaselli, C & Randi, V 2019, 'Blood derived treatment from two allogeneic sources for severe dry eye associated to keratopathy: A multicentre randomised cross over clinical trial', British Journal of Ophthalmology. https://doi.org/10.1136/bjophthalmol-2019-314859
Campos, Emilio ; Versura, Piera ; Buzzi, Marina ; Fontana, Luigi ; Giannaccare, Giuseppe ; Pellegrini, Marco ; Lanconelli, Nico ; Brancaleoni, Alessandra ; Moscardelli, Fabiana ; Sebastiani, Stefano ; Vaselli, Cristiana ; Randi, Vanda. / Blood derived treatment from two allogeneic sources for severe dry eye associated to keratopathy : A multicentre randomised cross over clinical trial. In: British Journal of Ophthalmology. 2019.
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AU - Campos, Emilio

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AU - Fontana, Luigi

AU - Giannaccare, Giuseppe

AU - Pellegrini, Marco

AU - Lanconelli, Nico

AU - Brancaleoni, Alessandra

AU - Moscardelli, Fabiana

AU - Sebastiani, Stefano

AU - Vaselli, Cristiana

AU - Randi, Vanda

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