September 2016
Volume 57, Issue 12
Open Access
ARVO Annual Meeting Abstract  |   September 2016
The importance of cell therapy controls for a safe, EU-approved Advanced Therapy Medicinal Product application to limbal stem cell deficiency
Author Affiliations & Notes
  • Graziella Pellegrini
    University of Modena and Reggio Emilia, Modena, Italy
  • Footnotes
    Commercial Relationships   Graziella Pellegrini, Holostem Terapie Avanzate Srl (S), Holostem Terapie Avanzate Srl (P), J-TEC Japan Tissue Engineering Co., Ltd. (C), Spouse - Holostem Terapie Avanzate Srl (S), Spouse - Holostem Terapie Avanzate Srl (P), Spouse - J-TEC Japan Tissue Engineering Co., Ltd. (C)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science September 2016, Vol.57, No Pagination Specified. doi:
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      Graziella Pellegrini; The importance of cell therapy controls for a safe, EU-approved Advanced Therapy Medicinal Product application to limbal stem cell deficiency
      . Invest. Ophthalmol. Vis. Sci. 201657(12):.

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      © 2017 Association for Research in Vision and Ophthalmology.

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Abstract

Presentation Description : Ocular burns or infections may destroy the limbus, causing limbal stem cell deficiency. The following invasion by conjunctiva, vessels and stromal scarring leads to corneal opacity and loss of vision. The only way to avoid this pathological picture, is to restore the limbus. Such restoration has been attained through surgical techniques by grafting limbal fragments or by growing in vitro a small limbal fragment to obtain an epithelium to be transplanted on patient.
The presentation will address the description of biological conditions driving the selection of cell therapy versus surgical approaches to such forms of limbal stem cell deficiency. A comparison of risks and related controls requested by the recent ATMP regulation with good clinical practice applied to tissue transplants, will be considered. Clinical experience, results and follow up of the different approaches will be discussed.

This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.

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