Research and future goals
Last year the MCB Cell Bank obtained an authorization (PZ-T.04061.4.2015.ASI) from the Minister of Health for harvesting, processing, storing and distribution of human skin cells - keratinocytes, fibroblasts and melanocytes, human mezenchymal stem cells isolated from bone marrow and fat tissue, human chondrocytes isolated from cartilaginous tissue, human muscle cells, extracellular adipose matrix and we obtained also scientific recommendations on classification of our advanced therapy medicinal products from EMA which are required to obtain the approval of Main Pharmaceutical Inspectorate for production of the advanced therapy medicinal products with hospital exemption HE-ATMP. This year the MCB Cell Bank obtained the consent of the Main Pharmaceutical Inspectorate (GIF-IW-400/0490/01/460/UA2/15) for production of the advanced therapy medicinal products with hospital exemption HE-ATMP which include all mentioned above.
Now we are ready to start produce HE-ATMP with cooperation:
- with clinical units for the use of ATMP products in treatment
- with biotechnological companies which strive for implementation of medicinal products
Also realization of scientific projects as a part of which medical experiments with the use of ATMP are anticipated – SUBCONTRACTING OF PROJECTS WHICH ASSUME THE USE OF ATMP- will be possible.
Particularly, in relation to the best experience of the qualified bank staff, realization of projects related to the use of skin cells in treatment of burns, chronical wounds and pathologic skin lesions, is assumed. Now, as one of the few Cell Banks in Poland, we have the necessary authorization to manufacture several HE - ATMP products as well as years of experience which allow us to effectively implement the intended assumptions of the project.
The Bank head will again apply for funding of the project related to implementation of 3 ATMP products:
- Clinical application of keratinocytes in treating burns and wounds which are hard to cure
- Mesenchymal adipose-derived stem cells (ASC): treating soft tissue defects of the rectum area
- The use of autologous chondrocytes in treating cartilaginous tissue defects
We plan to start cooperation with two companies, for which ATMP products will be produced.