- The EBMT Registry allows to register patients treated with Advanced Therapy Medicinal Products (ATMPs) manufactured from hematopoietic cells, including CAR-T cells, other immune effector cells-based therapies and stem cell-based cell or gene therapies, and capture short and long-term follow-up. The Cellular Therapy Med-A form was designed to capture all essential information describing the administered drug product and patient follow-up.
- The EBMT Registry – with the Cellular Therapy Med-A form now included - received a qualification opinion from EMA, recognizing its value to capture follow-up of patients treated with CAR-T cells.
- EBMT urges affiliated centres to register patients treated with commercial CAR-T cells to better understand the European landscape in this emerging therapeutic area and contribute to the thorough evaluation of the medical value of these breakthrough therapies, including long-term follow-up as mandated by health authorities.
- Registration of patients can be done in ProMISe, and will be facilitated when full migration to MACRO is achieved. Patients can be registered as soon as collection of autologous mononuclear cells is planned.
- Registration of patients treated with investigational CAR-T cells – whether in an academia- or industry-sponsored clinical trial – will provide additional insight into European activities in the field. CAR-T cells administered in the context of the hospital exemption are of special interest to fully evaluate the importance of this provision part of the ATMP regulation for academia and industry.
- Access to follow-up data by different stakeholders is the subject of the “Go-CART” project that brings together multiple stakeholders interested in the evaluation of CAR-T cells.
- EBMT will provide periodic updates on the number of registered patients.
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