A quick reference guide to preparing and infusing frozen stem cells.

This Roadmap Tool sets out the key steps and activities in the end-to-end pathway for Advanced Therapy Medicinal Products (ATMPs) in England from non-clinical research through to treatment provision & monitoring

The AAC is bringing together industry, government, regulators, patients and the NHS to remove barriers and accelerate the introduction of ground-breaking new treatments and diagnostics which can transform care, including ATMPs

This exemplar guideline suggests roles and responsibilities between CAR T cell referring centres and treatment centres. It also outlines common late adverse effects that may occur when patients have returned to their referring centre.

E-learning on the NHS e-learning platform e-learning for healthcare (registration required) giving the user a refresher of standard clinical trial studies and explains the additional features which impact on the design of trials for investigational advanced therapy medicinal products (ATIMPs) and how they can be addressed. Roles and responsibilities, governance and sources of support for ATIMP clinical trials are also outlined.

A guidance checklist for NHS staff in preparation for ATMP starting material procurement site qualification. This document would be best utilised when beginning to set up a service for procurement of a new cell or tissue type but could be used as a checklist for existing cell or tissue type procurement

CAR-T follow up checklist

An example SOP from University Hospitals Bristol and Weston NHS Foundation Trust to provide a safe and effective framework by which lymphodepletion can be performed in the outpatient setting, prior to admission for CAR-T Cell infusion.

A document summarising the challenges and solutions the the collection of starting materials for ATMP manufacture though apheresis

Training package to prove nurses with knowledge, skills and expertise to perform specific apheresis procedures for cellular therapy in a safe and professional manner.

A template of an apheresis weekly cleaning log.

This document summarises results from the safety testing conducted by Alcyomics of two of the exemplar products; tolerogenic dendritic cells and Anti-SARS-Cov-2 T cell product. A full report is expected to be published later on in 2022 in formal journal.

An example SOP from University Hospitals Bristol and Weston NHS Foundation Trust detailing the inclusion and exclusion criteria when referring patients to the Ambulatory Care (AC) BMT service.

A guidance document providing an oversight of the purposes and contents of a Quality Technical Agreement (QTA) for use between advanced therapy clinical trial Sponsor and Participating Organisation. The document set outs a proposed standardised format for advanced therapy clinical trial QTA with example roles and responsibilities.