Design guidelines for an umbilical cord blood stem cell therapy quality assessment model

Witold Januszewski (1), Michał Kobus (2), Krzysztof Michałek (3), Oleksandr Yagensky (4)
(1) Institute of Radioelectronics, Warsaw University of Technology
(2) Faculty of Mechatronics, Warsaw University of Technology
(3) Faculty of Chemical and Process Engineering, Warsaw University of Technology
(4) Departament of Medical Biotechnology, Jagiellonian University
Design guidelines for an umbilical cord blood stem cell therapy quality assessment model
Introduction
Umbilical cord blood stem cells are, along bone marrow and mobilized adult blood cells, one of the three most frequently used stem cell types for regenerative medicine therapy. Due to their immense therapeutic potential and ethical acknowledgement they deserve decent research coverage and recognition. However, optimisation of therapy quality requires an assessment model of an explanatory character, the design guidelines of which are presented in the article.
Materials
Several sources of data have been used to elicit the model parameters, including operational reports from FDA, European Association of Tissue Banks, Cord Blood Europe and Polish Centre for Tissue and Cell Banking as well as regenerative medicine clinical recommendations and reviewed scientific papers. The diseases taken under consideration for the therapy have been bone marrow diseases, leukaemia, immunity deficiency, diabetes, neurodegenerative diseases, osteoporosis, dystrophy and lesser muscle diseases. Regeneration procedures of the heart muscle and the liver have also been investigated.
Methods
The model parameters have been estimated through both theoretical analysis of various scientific papers and computer modelling of the therapeutic success rate. Several numerical analysis programming environments have been used to elicit the parameters of the model. Its verification was based on the comparison of the estimated stem cell therapy results with the conventional ones.
Results
The three main benchmarks included in the model are the odds of therapeutic success, approximate therapy costs and price/quality ratio. The obtained results have withstood both the verification criteria and the clinical best-practice guidelines.
Conclusion
The therapy quality assessment model proposed may serve for the pivotal purposes of stem cell therapy, that is, cell acquisition, proliferation, disposal and selection. Multiple agents related to stem cell therapy may benefit from usage of the elicited model, including biomedical scientists and healthcare service providers, as well as individual clinician practitioners.