Mesenchymal stromal cells
Umbilical cord tissue-derived mesenchymal stromal cells (MSCs) for healthcare professionals
NHS Blood and Transplant (NHSBT) manufactures and supplies cryopreserved, umbilical cord tissue-derived mesenchymal stromal cells (cMSCs) under an MHRA Specials Licence for use in named patients where the prescribing clinician determines there is a special clinical need that cannot be met by an appropriately licensed medicinal product.
Supply is subject to the requirements of the Human Medicines Regulations 2012 and MHRA Guidance Note 14 on unlicensed medicines ("specials").
Product overview
NHSBT-cMSC is an allogeneic MSC product manufactured from donated umbilical cord tissue obtained through regulated NHSBT donation programmes.
Cells are produced within MHRA-licensed, GMP-compliant cleanroom facilities using a validated manufacturing process and an automated closed-system bioreactor platform.
Cryopreserved products are stored in dedicated vapour-phase liquid nitrogen facilities and supplied with a Certificate of Analysis.
Key product characteristics include:
- umbilical cord tissue-derived allogeneic MSCs
- manufactured under GMP controls
- sterility, mycoplasma and endotoxin tested
- phenotype confirmed with flow cytometry
- post-thaw viability specification of ≥70%
- stored and transported at ≤-150°C
- maternal and donated umbilical cord Infectious Disease Marker tested
Important regulatory information
NHSBT-cMSC is an unlicensed medicinal product. Decisions regarding prescribing, suitability for treatment, patient consent, administration and follow-up remain the responsibility of the prescribing clinician. The clinician must be satisfied that the patient's special clinical needs cannot be met by a licensed alternative and that use of an unlicensed medicine is appropriate for the individual named patient.
Products are supplied only in response to an unsolicited request from an authorised healthcare professional and only where all applicable regulatory requirements are met.
Requesting NHSBT-cMSC for a patient
Before an cMSC product can be requested, there must be a valid Service Level Agreement in place between NHSBT and the requesting organisation.
Once an SLA has been executed, requests for cMSCs must be submitted by an authorised prescribing clinician using the NHSBT Clinical Request Form.
To avoid delays, requests should be submitted at least 10 working days before the planned treatment date. Product availability must be confirmed by NHSBT before patient treatment preparation begins.
Contact us
Healthcare professionals considering NHSBT-cMSC for a patient are encouraged to contact the Business Development Team to discuss product details, eligibility, logistics, storage requirements and ordering procedures.
Products can only be supplied to authorised individuals or hospital pharmacies able to receive and manage cryopreserved cellular therapy products.