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Prescribing Information SmPC

Treatment Process

The process of manufacturing Libmeldy involves blood stem cells being selected from the patient, a working copy of the ARSA gene inserted and the gene-corrected cells infused back into the patient.

Libmeldy: autologous CD34+ cells encoding the ARSA gene

Libmeldy gene therapy procedure is highly specialised

  • Libmeldy must be administered in a qualified treatment centre with experience in haematopoietic Stem Cell Transplantation (HSCT).

Libmeldy Qualified Treatment Centres (QTCs)

To ensure consistency and quality of treatment, Orchard Therapeutics has qualified QTCs in Europe to administer Libmeldy. All are experienced in haematopoietic stem cell transplantation and the management of leukodystrophies.

All QTCs have the required infrastructure, procedures and accreditations in place for:

  • autologous donations from paediatric patients.
  • collection of haematopoietic stem and progenitor cells via apheresis to collect mobilised peripheral blood.
  • patient care prior to (reception of the child and his family, carrying out clinical and instrumental tests to re-evaluate eligibility for treatment), during, and after (waiting for the immune system recovery and follow up) Libmeldy treatment.

 

 

If you have identified an MLD patient in your clinic, please contact one of the Qualified Treatment Centres (QTCs) or Orchard Therapeutics. You can either contact your local Orchard Therapeutics representative directly or send an email to: info@orchard-tx.com

▼ This medicinal product is subject to additional monitoring. Healthcare professionals are asked to report any suspected adverse events. Further information about local reporting details can be found in Section 4.8 of the Summary of Product Characteristics.
Please also report any adverse events to Orchard Therapeutics at: drugsafety@orchard-tx.com
For any medical questions, please contact medinfo@orchard-tx.com

EM-002-2600007 | May 2026