Cell Apheresis and Gene Therapies clinical trial referrals

Cell, Apheresis and Gene Therapies (CAGT) is a specialised directorate within NHS Blood and Transplant (NHSBT) that provides a range of services to support clinical trials.

There are 2 primary functions that provide these services within CAGT:

Cellular and Molecular Therapies (CMT) who provide laboratory services which includes the testing and cryopreservation of starting material, as well as receipt, storage and issue of Advanced Therapy Investigational Medicinal Products (ATIMPs).
Therapeutic Apheresis Services (TAS) who perform cell collection of starting materials for clinical trials, as well as various other therapeutic procedures such as plasma exchange, automated red cell exchange and ECP.

NHSBT CMT and TAS collaborate closely with hospitals across England. Your organisation may have its own apheresis unit or cell laboratory to support some aspects of the clinical trial who can work in collaboration with NHSBT as required to enhance support for your clinical trial.

Our dedicated Clinical Trials Team are the first point of contact for apheresis or laboratory support for your clinical trial and are responsible for coordinating the end-to-end process. All enquiries including requests should be directed to CAGTClinicalTrials@nhsbt.nhs.uk.

What is the clinical trial referral process?

Initial enquiry and referral

Requirements for submitting a clinical trial referral:

3 months notice is required at minimum to allow time for the review process to take place
Complete and return our clinical trial service request form which is available on this page - FRM6707 to us at CAGTClinicalTrials@nhsbt.nhs.uk
Complete and provide all relevant documents listed in FRM6707 and below in our FAQ section
CDA to enable free transfer of documents between NHSBT, the sponsor and the Trust
Submit all trial related documents to NHSBT for review
Provide manuals or detailed instructions for all requested services

FRM6707 lists the details and documents NHSBT require to understand the requirements, carry out due diligence and to make an informed decision to approve or reject the request.

If we do not have all the relevant information, this may cause a delay to the approval process.

NHSBT internal review and approval

A review of your request will typically take around 4 to 8 weeks to complete, depending on the complexity of the clinical trial.

This is to allow sufficient time to review apheresis and product handling manuals to ensure CAGT's existing processes and facilities are able to accommodate the trial’s requirements. The review will also ensure regulatory compliance with work undertaken on NHSBT's licences, assess staff capacity and impact on routine workload, and resolve any queries that we may request from you or the trial sponsor before confirming CAGT can support the request.

If your trial is approved following review, NHSBT will:

provide a quote for services
arrange the necessary contracts for your trial

Onboarding process

Once approved, during the onboarding process the following steps will take place:

Your Trust should attend monthly NHSBT planning meetings
All parties to arrange the necessary contracts
All parties to agree the clinical pathways
The referrer will audit NHSBT facilities when applicable
Logistic test runs involving TAS and CMT will be conducted where applicable but are always preferred by NHSBT

Trial start

Next steps

Important forms

Start the clinical trial referral process:

Clinical trial service request form - FRM6707 (Word 107KB)

Use our referral forms once your trial is onboarded:

Important additional information

What services can NHSBT offer for clinical trials?

Who can access or request clinical trial services?

How do I request NHSBT services for a new clinical trial?

Please complete FRM6707 and return to CAGTClinicalTrials@nhsbt.nhs.uk. A member of our dedicated Clinical Trials Team will be in touch.

Following, the request will undergo an internal review and depending on the complexity of the clinical trial. We aim to provide an outcome within 8 weeks.

If approved, you will receive information about the next steps to onboard.

Note: the initial review can only commence once all clinical trial documents have been finalised and submitted to NHSBT.

What can I expect if a clinical trial is approved?

We will ask you to provide the details of a key contact who will be expected to attend a short monthly planning meeting with our Clinical Trials Team. External sponsors are not permitted to attend the meeting.

The regular meetings are where updates and key information will be shared between both parties and also provides an opportunity to discuss any concerns.

It is important to maintain good communication and collaboration between all parties throughout the clinical trial process to ensure a smooth and successful delivery.

Please notify NHSBT of any changes to the status of the clinical trial, this includes all protocol amendments, ethical and regulatory changes.

How much does it cost?

What documents do I need to provide to NHSBT?

Does NHSBT have the necessary licences for cellular therapy collection, processing and storage

When and how do I make a referral for the patient/donor to TAS?

What testing services are available?

For CMT

NHSBT, CMT laboratories can perform blood counts (FBC and white cell differentials) on starting material.

Infectious disease marker (IDM) testing reports (-30 day and day 0) can be provided by CMT via the NHSBT Testing laboratory in Manchester.

All CMT labs are equipped with validated flow cytometers to perform the routine tests detailed below; other tests may be requested but would need to be developed.

CD3+ enumeration, a sample of the collected product can be taken by the TAS unit and sent to the CMT laboratory for CD3+ enumeration.
CD34+ & CD45+ enumerations with 7-Aminoactinomycin D (7-AAD) exclusion dye for cell viability assessment.
Hematopoietic Colony Forming Unit (CFU) assays can be performed as an additional cell viability test upon request.

For TAS

The TAS unit can take patient blood samples which can be sent to a relevant laboratory to perform full blood count and white cell differentials, pre and post apheresis procedure using validated haematology analysers.

NHSBT and CMT can perform further testing on apheresis collection samples as described above.