Therapeutic and economic implications of regulating stem cell therapy and blood components

Abstract

The objectives of the study were to 1) Identify European collaborators in the area of stem cell therapy and blood components 2) Establish a network of collaborators to investigate the setting up of a stem cell therapy unit in Malta 3) Address requirements for setting up a stem cell therapy unit and consider economic implications 4) Identify regulatory sciences norms for regulators of stem cell therapy facilities and blood establishments and 5) Compile a glossary of terminology for use in the field of stem cell therapy and blood components. The methodology included building a structured collaboration involving the identification of key stakeholders and key indicators. Business models for developing a stem cell therapy unit were analysed through the network. Economical implications for set-up, maintenance and treatment were determined and evaluated. A quality manual for regulators inspecting stem cell therapy facilities and blood establishments was developed as part of the regulatory sciences norms. The terms selected for the glossary were identified through collaborations and discussions with experts in the field of stem cell therapy and blood components. Five site studies were carried out at King’s College in London (academic), Holostem Terapie Avanzate in Modena (industry), CTP System in Florence (technical specialists) and the Health Products Regulatory Authority in Ireland (regulator). A public-private partnership was identified as a business model for setting up a stem cell therapy unit to include the skills and assets of the public and the financial acumen of the private investors. Identified facilities for the Malta stem cell project were a research laboratory (36m2) at the University of Malta (UOM) and a Good Manufacturing Practice (GMP) laboratory (500m2) as the manufacturing facility at the Malta Life Sciences Park (MLSP). Economical implications involved MLSP rent (€100/m2/year), setting up a Class B processing laboratory (€5,000/m2), equipment (c€300,000) and personnel (c€600,000/year). Therapy charges range from c€3,000/treatment for hepatocyte transplantation to c€50,000/patient for adipose stem cells for aesthetic medicines. The quality manual for regulators included an ‘Aide Memoire’ as a practical guidance and a glossary of one hundred and sixty terms was compiled and validated. Collaborative partnerships served to up-skill knowledge and competency in stem cell therapy and blood components. The results point to the need of a feasibility study which in itself costs between €15,000 and €25,000.