The Mallinckrodt ECP Immunomodulation investigator award

Past Winners

Andrew Fisher, Professor of Respiratory Transplant Medicine at Newcastle University, and Honorary Consultant Respiratory and Transplant Physician at The Newcastle upon Tyne Hospitals NHS Foundation Trust’s Institute of Transplantation.

Andrew Fisher, the project’s principal investigator won this year’s award for a project to help address significant unmet medical need by evaluating responses to extracorporeal photopheresis therapy (ECP) in chronic lung allograft dysfunction (CLAD).

The study hopes to identify potential novel biomarkers that could guide a precision-medicine approach to ECP treatment, and help people avoid the disability and mortality associated with CLAD – a devastating complication that affects more than half of lung transplant recipients within five years.

See Press Release for more detail.

RIGHT institute (UMR1098) in collaboration with the University Hospital Besançon, France lead by Dr. Etienne Daguindau.

A project that will analyze the immunomodulatory effects of extracorporeal photopheresis therapy (ECP) through innate cells won the Mallinckrodt plc’s 2021 Advances in Immunomodulatory ECP research award

The winning project, seeks to investigate mechanisms of cell death generated through ECP and the direct effects on the innate cells involved in the resolution of inflammation.

See Press Release for more detail.

Professor David Launay of the University Hospital of Lille in France.

Prof. Launay is based at the Department of Internal Medicine and Clinical Immunology at the University Hospital of Lille, the France-National Reference Center for Systemic and Autoimmune Diseases and part of the European Reference Network ReCONNECT and also works at the Institute for Translational Research in Inflammation (Infinite – U1286 Inserm | Univ. Lille | CHU Lille) in Lille.

The winning entry will evaluate the impact of immunomodulatory intervention on the development of fibrosing processes in an experimental model that could underpin the efficacy of ECP immunomodulation on immune-mediated inflammatory diseases (IMIDs). Among chronic diseases, IMIDs represent a common cause of fibrosis, a hardening or scarring of tissue, and the end result of many chronic inflammatory reactions. Fibrosis carries a high morbi-mortality rate, and a lack of effective therapies to prevent or reverse fibrosis presents a major issue for clinicians.¹

See Press Release for more detail.

1. TA Wynn, Cellular and molecular mechanisms of fibrosis, J Pathol 2008; 214: 199–210, https://doi.org/10.1002/path.2277, et al.

Newcastle University, in collaboration with Medical University, Graz and Newcastle Hospitals NHS Foundation Trust

The winning entry was submitted by co-investigator Dr. Rachel Crossland of Newcastle University in the United Kingdom. Collaborators on the winning project include Professor Anne Dickinson, Professor of Marrow Transplant Biology, Newcastle University, Professor Hildegard Greinix, Director of Haematology, Medical University Graz, Graz, Austria; and Dr. Aisling Flinn, Clinical Research Associate in Paediatric Immunology, Newcastle Hospitals NHS Foundation Trust.

Their 12-month study will investigate the impact of ECP Immunomodulation on extracellular vesicles and their profiles in response to therapy in patients with graft-versus-host disease (GvHD). A major complication affecting between 40-70% of Hematopoietic Stem Cell Transplant (HSCT) patients, severe GvHD carries a high mortality rate.1

See Press Release for more detail.

1. Jagasia M, Arora M, Flowers ME, et al. Risk factors for acute GVHD and survival after hematopoietic cell transplantation, Blood. 2012 Jan 5;119(1):296-307. doi: 10.1182/blood-2011-06-364265. Epub 2011 Oct 18.

Dr. Nick Matthews and co-investigator Dr. Arun Alfred of the Department of Haematology at Rotherham NHS Foundation Trust in the United Kingdom.

Their proposal seeks to establish whether immunomodulation achieved through extracorporeal photopheresis (ECP) used in treatment of chronic graft-versus-host disease (GVHD) occurs through mediation of in vivo macrophage activation. Along with the 2018 Investigator Award, the Department of Haematology at Rotherham NHS Foundation Trust will receive an educational grant of €50,000 to support this research.

See Press Release for more detail.

IMPORTANT SAFETY INFORMATION FOR THE THERAKOS™ PHOTOPHERESIS PROCEDURE

Indications

The THERAKOS^TM CELLEX^TM Photopheresis System is indicated for the administration of photopheresis. Please refer to the appropriate product labelling for a complete list of warnings and precautions.

Contraindications

THERAKOS^TM Photopheresis is contraindicated in:

Patients possessing a specific history of a light sensitive disease.
Patients who cannot tolerate extracorporeal volume loss or who have white blood cell counts greater than 25,000 / mm³.
Patients who have coagulation disorders or who have previously had a splenectomy.

Warnings and Precautions

THERAKOS^TM Photopheresis treatments should always be performed in locations where standard medical emergency equipment is available. Volume replacement fluids and/or volume expanders should be readily available throughout the procedure. Safety in children has not been established.

Do not expose the device to a magnetic resonance (MR) environment. The device may present a risk of projectile injury, and thermal injury and burns may occur. The device may generate artifacts in the MR image, or may not function properly.
Thromboembolic events, including pulmonary embolism and deep vein thrombosis, have been reported in the treatment of Graft versus Host Disease (GvHD). Special attention to adequate anticoagulation is advised when treating patients with GvHD.
When prescribing and administering THERAKOS^TM Photopheresis for patients receiving concomitant therapy, exercise caution when changing treatment schedules to avoid increased disease activity that may be caused by abrupt withdrawal of previous therapy.

Adverse Events

Hypotension may occur during any treatment involving extracorporeal circulation. Closely monitor the patient during the entire treatment for hypotension.
Transient pyretic reactions, 37.7–38.9°C (100–102°F), have been observed in some patients within six to eight hours of reinfusion of the photoactivated leukocyte-enriched blood. A temporary increase in erythroderma may accompany the pyretic reaction.
Treatment frequency exceeding labelling recommendations may result in anaemia.
Venous access carries a small risk of infection and pain.

Please refer to the THERAKOS^TM CELLEX^TM Photopheresis System Operator Manual for a complete list of warnings and precautions.

IMPORTANT SAFETY INFORMATION FOR METHOXSALEN USED IN CONJUNCTION WITH THERAKOS^TM PHOTOPHERESIS

Contraindications

Methoxsalen is contraindicated in:

Patients exhibiting idiosyncratic or hypersensitivity reactions to methoxsalen, psoralen compounds, or any of the excipients
Patients with co-existing melanoma, basal cell or squamous cell skin carcinoma
Patients who are pregnant, and sexually active men and women of childbearing potential unless adequate contraception is used during treatment
Patients with aphakia because of the significantly increased risk of retinal damage due to the absence of a lens

Warnings and Precautions

Special care should be exercised in treating patients who are receiving concomitant therapy (either topically or systemically) with known photosensitizing agents.
Oral administration of methoxsalen followed by cutaneous UVA exposure (PUVA therapy) is carcinogenic.
Patients should be told emphatically to wear UVA absorbing, wrap-around sunglasses for twenty-four (24) hours after methoxsalen treatment. They should wear these glasses any time they are exposed to direct or indirect sunlight, whether they are outdoors or exposed through a window.
Safety in children has not been established.

Refer to the package insert for methoxsalen sterile solution (20 micrograms / mL) or the oral 8-methoxypsoralen dosage formulation for a list of all warnings and precautions.

Please refer to the THERAKOS^TM CELLEX^TMPhotopheresis System Operator Manual for a complete list of warnings, precautions and adverse events.

The Mallinckrodt ECP Immunomodulation investigator award

Past Winners

2022

2021

2020

2019

2018

The Mallinckrodt ECP Immunomodulation investigator award

Past Winners

2022

2021

2020

2019

2018

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IMPORTANT SAFETY INFORMATION FOR THE THERAKOS™ PHOTOPHERESIS PROCEDURE

IMPORTANT SAFETY INFORMATION FOR METHOXSALEN USED IN CONJUNCTION WITH THERAKOSTM PHOTOPHERESIS

IMPORTANT SAFETY INFORMATION FOR METHOXSALEN USED IN CONJUNCTION WITH THERAKOS^TM PHOTOPHERESIS