The use of novel Therakos™ Cellex^® for extracorporeal photopheresis in treatment of graft‐versus‐host disease in paediatric patients

Abstract

SummaryExtracorporeal photopheresis (ECP) is an established second line treatment option for graft-versus-host disease (GVHD) post-haematopoietic progenitor cell transplant. At our centre, the Therakos TM Cellex ® has replaced the Therakos TM UVAR-XTS TM machine for ECP since 2009. We reviewed the records of 385 procedures using the Therakos TM Cellex ® for safety and tolerability. Nine patients underwent ECP for GVHD. The median age was 13Á5 years (range 3Á7-24) and weight was 49Á2 kg (range 18Á5-86Á3). The mean duration per procedure was 106 min (range 60-205). Fifteen (3Á9%) procedures were cancelled and 10 (2Á6%) were delayed, with central venous line (CVL) issues being the most frequent problem. With the use of prophylactic tissue plasminogen activator, fewer CVL-related occlusions were observed (4Á7% vs. 2Á3%). There was one episode of a CVL-associated thrombosis and one episode of delayed bleeding. There were four episodes of viral reactivation, four CVL-associated infections (1142 catheter days) and one episode of systemic inflammatory response syndrome. No patient experienced symptomatic hypotension. This is the first report outlining the safety and tolerability of the Therakos TM Cellex ® device for ECP in children and young adults.

Recent advances in the management of graft-versus-host disease

“…Available evidence thus indicates that ECP is a valuable option for treatment of acute and chronic GvHD with proven safety in children 43. The main advantage is that it allows reduction in other immunosuppressive therapy that lessens the risk of immunosuppression-related morbidity and mortality.…”

Mini photopheresis for refractory chronic graft‐versus‐host disease in children and adolescents

“…However, one drawback of the mini‐ECP procedure compared to other ECP systems, for example, Therakos TM, is its dependency on an established manual buffy coat preparation and a UVA irradiation procedure. Newer ECP devices (e.g., Therakos TM Cellex (R)) represent an automated alternative to the mini‐ECP procedure for some patients . However, central venous line issues remain a major problem and potential risks of blood priming in each procedure is a cause for concern (Table ) …”

“…Newer ECP devices (e.g., Therakos TM Cellex (R)) represent an automated alternative to the mini‐ECP procedure for some patients . However, central venous line issues remain a major problem and potential risks of blood priming in each procedure is a cause for concern (Table ) …”

Extracorporeal Photopheresis: Scientific and Technical Considerations for Improving Clinical Management of Patients

“…Moreover this automatic process is more appropriate for adult patients, than for pediatric patients. The FDA approval for an ECP protocol inclusion is restricted by a body weight of at least 40kg because of the [27]. Finally, there is no quality control available on the infused product.…”

“…In the absence of reliable management parameters, either quality control on the processed cells either clinically relevant marker, schedules of treatment remain empiric. Based on the total amount of lymphocytes treated, the short duration of procedure, the recent trials in GVHD with the Therakos™ Cellex ® system report the use of repeated numerous courses (10 to 60) over 1 to 17 months [27,31].…”