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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).

Availability at Qualified Treatment Centers

To ensure consistency and quality of treatment, Libmeldy will be available via qualified treatment centres with adequate experience in haematopoietic stem cell transplantation and the management of leukodystrophies. (see above)

The qualified treatment centre has the required infrastructure, procedures and accreditations in place, which are:

  • Appropriate for autologous donations from paediatric patients.
  • For the collection of haematopoietic stem and progenitor cells via apheresis to collect mobilised peripheral blood or via bone marrow harvest.

 

 

If you have identified an MLD patient in your clinic, please contact your local Orchard Therapeutics representative or send an email to:
info@orchard-tx.com