Department of Clinical Immunology, Næstved Hospital

The Department of Clinical Immunology, Næstved Hospital, holds authorisation to perform activities regarding human tissues and cells. The department collect, process, and store bone marrow stem cells from patients suffering from certain haematological diseases for use in autologous stem cell transplantation. The department comprise an allogeneic bone bank receiving bone tissue from patients undergoing orthopaedic surgery in hospitals in the Sjælland region. Additionally, it provides a highly specialised cleanroom class B, where cell products are being prepared for patients’ use. Currently, the department has established a method for cultivating mesenchymal stem cells in the purpose of building an allogeneic stem cell bank for use in clinical studies. The department performs various flow cytometric analyses, including analyses for the characterisation of hematopoietic and mesenchymal stem cells. Specifications for all starting materials, intermediate and finished products in the quality system and also, in the blood bank IT system ensure correct labelling and full traceability of all materials and products.


Tasks in the project:

  • Preparation of platelet lysate for  cultivation according to GMP requirements
  • Development of a culturing protocol for bone marrow mesenchymal stem cells from patients undergoing a planned hip surgery
  • Analyses for characterisation and quality control
  • Setting up commodity, sub and end products in the department's blood bank system to ensure full traceability and correct labeling
  • Prepare and submit an application for GMP approval of the mesenchymal stem cell product for clinical studies

Contact:

Susanne Saekmose
Ringstedgade 77B, 4700 Næstved
E-Mail: sugs@regionsjaelland.dk