Clinical practice

Clinical practice

Information is available here to support building understanding of how clinical sites deliver advanced therapies to patients, including details of patient assessment, handling advanced therapies, product administration, infusion, treatment and monitoring and recording treatment and side-effects.


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Apheresis process flow

A document summarising the challenges and solutions the the collection of starting materials for ATMP manufacture though apheresis.
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Cytokine release syndrome assessment for CAR-T therapy – Newcastle Hospitals

A tool to assess for and grade cytokine release syndrome in a CAR T therapy patient.
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Diagnosis and medical management of acute CAR-T cell toxicities in adults

This document produced by the Pan UK Pharmacy Working Group for ATMPs provides guidance on the management of acute CAR-T cell toxicities to help inform the development of local guidelines and to standardise the management of acute CAR-T cell toxicities across the UK. This is a consensus guideline developed with input from the pharmacists and consultants from the first and second wave CAR-T centres.
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In Vivo (virus based) gene therapy medicinal products – pharmacy institutional readiness guidance

The purpose of document produced by the Pan UK Pharmacy Working Group for ATMPs is to outline the key areas where chief pharmacists should focus pharmaceutical expertise prior to an organisation implementing any in vivo (virus based) Gene Therapy Medicinal Product (GTMP) e.g. IMP for Clinical Trials or Marketed ATMPs.
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Medication restrictions for patients having CAR-T-cell therapy

There are a number of restrictions in medicines allowed (and wash-out periods recommended) for patients on CAR-T Cell therapy at each stage of the pathway (apheresis lymphodepletion CAR-T infusion). This guidance has been produced by the Pan UK Pharmacy Working Group for ATMPs to document useful medication restriction information for CAR-T Cell therapy.
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Neurotoxicity assessment for CAR-T cell therapy

A tool to assess for and grade Immune Effector Cell Associated Neurotoxicity Syndrome neurotoxicity in a CAR-T therapy patient.
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Recommendations for Gene Therapy Patient Referrals Pathway

A summary of recommendations for Gene Therapy Patient Referrals Pathway
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Recommendations for Gene Therapy Patient Referrals Pathway Infographic

An infographic capturing the recommendations for Gene Therapy Patient Referrals Pathway.
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Recommendations on the procurement of starting materials by apheresis for ATMP manufacture

This guidance document presents a consensus view on standardised approaches to mononuclear cell procurement to reduce unnecessary complexity and variation.
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Referring Sarcoma Patients for Cell Therapy Clinical Trials: A UK Wide Survey of Current Referral Routes and Practices to Identify Gaps in the Referrals Process and Maximise Patient Access to Cell Therapy Clinical Trials

A UK Wide Survey of Current Referral Routes and Practices to Identify Gaps in the Referrals Process and Maximise Patient Access to Cell Therapy Clinical Trials.
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SOP: Handling and Administration of In vivo GMO Gene Therapies

This example SOP considers general principles for the handling and administration of an example in vivo GMO gene therapy in a clinical area which can be adapted to accommodate local procedures or product-specific requirements.
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Supportive Medicines for Adults Receiving Marketed CAR-T Cell Therapy

Prior to receiving CAR-T cell therapy patients will receive lymphodepletion chemotherapy.  CAR-T cell therapy and lymphodepletion regimes can increase the likelihood of certain side effects and infections so supportive medicines are recommended.These consensus recommendations prepared by the Clinical Pharmacy subgroup of the Pan UK Pharmacy Working Group for Advanced Therapy Medicinal Products (ATMPs) relate to supportive medicines recommended for adults receiving licensed CAR-T cell therapy.
PPTX

Thawing and visual inspection of cell therapy medicinal products

A training resource on the importance of correctly thawing and inspecting cell therapy medicinal products.