Use of a maturity model for facilitating the introduction of CAR T-cell therapy—Results of the START CAR-T project


  • Stefania Bramanti BMT Unit, IRCCS Humanitas Research Hospital, Rozzano - Italy
  • Matteo Carrabba Hematology and Bone Marrow Transplantation Unit, IRCCS San Raffaele Scientific Institute, Milan - Italy
  • Alice Di Rocco COU Hematology, AOU Policlinico Umberto I, Rome - Italy
  • Elena Fabris Department of Management, Economics and Industrial Engineering (DIG), Politecnico di Milano, Milan - Italy
  • Luca Gastaldi Department of Management, Economics and Industrial Engineering (DIG), Politecnico di Milano, Milan - Italy
  • Paolo Locatelli Department of Management, Economics and Industrial Engineering (DIG), Politecnico di Milano, Milan - Italy
  • Maria Chiara Tisi Cell Therapy and Hematology, San Bortolo Hospital, Vicenza - Italy



Digital Transformation, Haematological Immunotherapy, Healthcare Management, Innovation, Maturity Model


Introduction: Chimeric antigen receptor (CAR) T-cell therapies are novel immunotherapies for the treatment of hematologic malignancies. They are administered in specialized centers by a multidisciplinary team and require the careful coordination of all steps involved in manufacturing and using cellular therapies. The Maturity Model (MM) is a tool developed and used for assessing the effectiveness of a variety of activities. In healthcare, it may assist clinicians in the gradual improvement of patient management with CAR T-cell therapy and other complex treatments.

Methods: The START CAR-T project was initiated to investigate the potential of a MM in the setting of CAR T-cell therapy. Four Italian clinics participated in the creation of a dedicated MM. Following the development and test of this MM, its validity and generalizability were further tested with a questionnaire submitted to 18 Italian centers.

Results: The START CAR-T MM assessed the maturity level of clinical sites, with a focus on organization, process, and digital support. For each area, the model defined four maturity steps, and indicated the actions required to evolve from a basic to an advanced status. The application of the MM to 18 clinical sites provided a description of the maturity level of Italian centers with regard to the introduction of CAR T-cell therapy.

Conclusion: The START CAR-T MM appears to be a useful and widely applicable tool. It may help centers optimize many aspects of CAR T-cell therapy and improve patient access to this novel treatment option.


Download data is not yet available.


Katz B-Z, Herishanu Y. Therapeutic targeting of CD19 in hematological malignancies: past, present, future and beyond. Leuk Lymphoma. 2014;55(5):999-1006. PMID:23885836 DOI:

Greenbaum U, Mahadeo KM, Kebriaei P, Shpall EJ, Saini NY. Chimeric antigen receptor T-cells in B-acute lymphoblastic leukemia: state of the art and future directions. Front Oncol. 2020;10:1594. PMID:32984022 DOI:

Elsallab M, Levine BL, Wayne AS, Abou-El-Enein M. CAR T-cell product performance in haematological malignancies before and after marketing authorisation. Lancet Oncol. 2020;21(2):e104-e116. PMID:32007196 DOI:

Gotti M, Defrancesco I, D’Angelo M, et al. Cancer Immunotherapy using chimeric antigen receptor expressing T-cells: present and future needs of clinical cancer centers. Front Immunol. 2020;11:565236. PMID:33193333 DOI:

Aljurf M, Snowden JA, Hayden P, Orchard KH, McGrath E. Quality management and accreditation in hematopoietic stem cell transplantation and cellular therapy. The JACIE Guide. Accessed June 9, 2021. DOI:

Tarhan A, Turetken O, van den Biggelaar FJHM. Assessing healthcare process maturity: challenges of using a business process maturity model. Proceedings of the 9th International Conference on Pervasive Computing Technologies for Healthcare 2015; 344-347. Online Accessed June 9, 2021.

De Bruin T, Rosemann M, Freeze R, Kulkarni U. Understanding the main phases of developing a maturity assessment model. ACIS 2005 Proceedings. Sydney, NSW, Australia

th Australasian Conference on Information Systems 2005; 8-19.

Fisher, DM. The Business Process Maturity Model. A practical approach for identifying opportunities for optimization. BPTrends 2004. Accessed June 9, 2021.

Mettler T, Rohner P, Winter R. Towards a classification of maturity models in information systems. In D’Atri A, De Marco M, Braccini AM, Cabiddu F (Eds), Management of the interconnected world (pp. 333-340). Springer-Verlag Berlin Heidelberg 2010. DOI:

Röglinger M, Pöppelbuß J, Becker J. Maturity models in business process management. Bus Process Manag J. 2012;18(2):328-346. DOI:

Iversen J, Nielsen PA, Norbjerg J. Situated assessment of problems in software development. ACM SIGMIS Database. 1999;30(2):66-81. DOI:

Locatelli P, Cirilli F, Panno E, Provenzano S, Sanfilippo R, Casali P. Digital Support for Hub-and-Spoke Disease Network. Proceedings of the 12th IADIS International Conference e-Health 2020, EH 2020 - Part of the 14th Multi Conference on Computer Science and Information Systems, MCCSIS 2020; 2020: 198-202.

Bitter J, van Veen-Berkx E, Gooszen G, van Amelsvoort P. Multidisciplinary teamwork is an important issue to healthcare professionals. Team Perform Manage. 2013;19(5/6):263-278. DOI:

Grassi MO, Furino C, Recchimurzo N, et al. Implementation of Lean healthcare methodology in designing an Intravitreal Injection Center: first Italian experience. Int Ophthalmol. 2020;40(10):2607-2615. PMID:32514665 DOI:

Locatelli P, Restifo N, Gastaldi L, Sini E, Torresani M. The evolution of hospital information systems and the role of electronic patient records: from the Italian scenario to a real case. Stud Health Technol Inform. 2010;160(Pt 1):247-251. PMID:20841687

Wood JC, Wood MC. W. E. Deming: Critical evaluation in business and management. Routledge 2005; 2: 87-107.

Avitabile T, Boscia F, Dell’Erba A, et al. Definition of indicators of appropriateness in the management of neovascular age-related macular degeneration: an expert opinion. Eur J Ophthalmol. 2020;30(4):795-804. PMID:32389030 DOI:

Locatelli P, Facchini R, Moser R et al. Effectively introducing mobile solutions in hospitals: the importance of process perspective and KPIs. Proceedings of the IEEE 27th International Symposium on Computer-Based Medical Systems 2014; 417-420. DOI:



How to Cite

Bramanti, S., Carrabba, M., Di Rocco, A., Fabris, E., Gastaldi, L., Locatelli, P., & Tisi, M. C. (2022). Use of a maturity model for facilitating the introduction of CAR T-cell therapy—Results of the START CAR-T project. Global and Regional Health Technology Assessment, 9(1), 1–8.



Original Research Articles


Received 2021-09-09
Accepted 2021-12-06
Published 2022-01-08