The « MATHEC-SFGM-TC » registry was designed to collect annual follow-up data from patients treated by hematopoietic cell therapies (HCT) for autoimmune diseases (AD), namely autologous or allogeneic Hematopoietic stem cells (HSCT), Mesenchymal Stroma Cells (MSC), CAR-T cells or others, as recommended for Good Clinical Practices (GCP) by the European Society for Blood and Bone Marrow Transplantation (EBMT) and the Joint Accreditation Committee of the International Society for Cell Therapy (ISCT) and EBMT (JACIE) (click here).
The MATHEC-SFGM-TC registry is declared to the French ‘Commission Nationale de l’Informatique et des Libertés (CNIL). It was originally developed with expertise of several members of the Autoimmune Disease Working Party of EBMT and then set up in France with the support of MATHEC Saint-Louis Reference Centre for stem cell therapy in AD, according to the rare diseases national plan (PNMR 3) in close collaboration of the in accordance with the Société Francophone de Greffe de Moelle et de Thérapie Cellulaire (SFGM-TC) and the Filière de santé des maladies Auto-Immunes et Auto-Inflammatoires Rares (FAI2R) operating rules . The MATHEC registry is hosted by Epiconcept, a certified health data host company, with high level of protection for its infrastructures and for the patients data.
Each center participating reporting patients data the MATHEC registry owns the property of his patients data and has full access to these data.
Collection of data in the « MATHEC-SFGM-TC » registry:
- – Includes the minimum data set data related to patient clinical evaluation before and at 3 months and yearly after cell therapy (HCT, MSC, CART or other CT products) during standard follow-up to assess survival, autoimmune disease status (AD remission or stable, relapse, progression), onset of complications (toxicity, infections) and concomitant treatments;
- – is performed with signed agreement from the responsible person of the graft
centers affiliated to the SFGM-TC and/or the specialist physician in charge of the patient follow-up once by cell therapy for autoimmune disease (AD) (hematologist, internist, rheumatologists, neurologist, gastro-enterologist) in the MATHEC-SFGMTC network;
- – requires written consent from the patient, after presentation of the dedicated information note, so that the patient can authorize the collection and processing of his or her data (document downloadable here for patients transplanted in France, and here for patients transplanted outside France).
For any complementary information, you can join Pauline Lansiaux (Ingénieure de recherche) pauline.lansiaux@aphp.fr ou Ingrid Munia (Coordinatrice d’études cliniques) ingrid.munia@aphp.fr.