AAPS PharmSciTech

, 12:893 | Cite as

Platelet Lysate Mucohadesive Formulation to Treat Oral Mucositis in Graft Versus Host Disease Patients: A New Therapeutic Approach

  • Claudia Del Fante
  • Cesare Perotti
  • Maria Cristina Bonferoni
  • Silvia Rossi
  • Giuseppina Sandri
  • Franca Ferrari
  • Luigia Scudeller
  • Carla Marcella Caramella
Research Article

Abstract

Optimal treatment of oral mucositis (OM) due to graft versus host disease (GvHD) is currently not available. Platelet-derived growth factors (PDGFs) have high capability for tissue healing and may play a role in repairing the mucosal barrier. The aim of the present work was to develop a mucoadhesive formulation to administer platelet lysate to oral cavity prolonging contact time of platelet lysate with oral mucosa. The mucoadhesive formulation was characterized for in vitro properties (PDGF-AB concentration, mucoadhesive properties, cytotoxicity, fibroblast proliferation, wound healing). Moreover, a preliminary clinical study on seven GvHD patients with OM refractory to other therapies was conducted, to evaluate feasibility, safety, and efficacy. GVPL (mucoadhesive gel vehicle mixed with platelet lysate)showed good mucoadhesive properties; additionally, it was characterized by good biocompatibility in vitro on fibroblasts and it was able to enhance fibroblast proliferation and wound healing, maintaining the efficacy for up to 14 days following storage at 2–8°C. In vivo, clinical response was good-to-complete in five, fair in one, none in the remaining one. The in vitro results indicate that GVPL has optimal mucoadhesive and healing enhancer properties, maintained over time (up to 14 days); preliminary clinical results suggest that oral application of platelet lysate-loaded mucoadhesive formulation is feasible, safe, well tolerated, and effective. A larger controlled randomized study is needed.

KEY WORDS

in vitro proliferation and wound healing test in vivo assessment in graft versus host disease mucositis platelet lysate growth factors 

Notes

Acknowledgments

The authors wish to thank Cariplo Foundation for the financial support (Project title: “Platelet gel bioadhesive systems for mucositis in chemio/radio therapy and stem cell trasplantation” call 2006).

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Copyright information

© American Association of Pharmaceutical Scientists 2011

Authors and Affiliations

  • Claudia Del Fante
    • 1
  • Cesare Perotti
    • 1
  • Maria Cristina Bonferoni
    • 2
  • Silvia Rossi
    • 2
  • Giuseppina Sandri
    • 2
  • Franca Ferrari
    • 2
  • Luigia Scudeller
    • 3
  • Carla Marcella Caramella
    • 2
  1. 1.Immunohaematology and Transfusion Service, Apheresis And Cell Therapy UnitFondazione IRCCS Policlinico S. MatteoPaviaItaly
  2. 2.Department of Drug SciencesUniversity of PaviaPaviaItaly
  3. 3.Clinical Epidemiology and Biometric UnitFondazione IRCCS S. MatteoPaviaItaly

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