Preprint Article Version 1 This version is not peer-reviewed

Extracorporeal Photopheresis of Patients with Crohn’s Disease Using 5-Aminolevulinic Acid – a First-in-Human Phase I/II Study

Kristian Espeland
* ,
Eidi Christensen
ORCID logo ,
Astrid Aandahl
,
Andreas Ulvær
,
Trond Warloe
,
Andrius Kleinauskas
,
Sagar Darvekar
,
Petras Juzenas
ORCID logo ,
Vlada Vasovic
ORCID logo ,
Qian Peng
ORCID logo ,
Jørgen Jahnsen
ORCID logo
Version 1 : Received: 24 September 2024 / Approved: 24 September 2024 / Online: 24 September 2024 (14:21:21 CEST)

How to cite: Espeland, K.; Christensen, E.; Aandahl, A.; Ulvær, A.; Warloe, T.; Kleinauskas, A.; Darvekar, S.; Juzenas, P.; Vasovic, V.; Peng, Q.; Jahnsen, J. Extracorporeal Photopheresis of Patients with Crohn’s Disease Using 5-Aminolevulinic Acid – a First-in-Human Phase I/II Study. Preprints 2024, 2024091931. https://doi.org/10.20944/preprints202409.1931.v1 Espeland, K.; Christensen, E.; Aandahl, A.; Ulvær, A.; Warloe, T.; Kleinauskas, A.; Darvekar, S.; Juzenas, P.; Vasovic, V.; Peng, Q.; Jahnsen, J. Extracorporeal Photopheresis of Patients with Crohn’s Disease Using 5-Aminolevulinic Acid – a First-in-Human Phase I/II Study. Preprints 2024, 2024091931. https://doi.org/10.20944/preprints202409.1931.v1

Abstract

Background/Objectives: With the increasing prevalence of Crohn’s disease (CD), treatment op-tions for patients who fail conventional and advanced therapy are highly needed. Therefore, we explored the safety and efficacy of extracorporeal photopheresis (ECP) using 5-aminolevulinic acid (ALA) and blue light (405 nm). Methods: Patients with active CD who failed or were intolerant to biological therapy were eligi-ble. Mononuclear cells (90 mL) were collected from each patient using a Spectra Optia® apheresis system and diluted with 100 mL of 0.9% sodium chloride in a collection bag. The cells were in-cubated with ALA at a concentration of 3 millimolar (mM) for 60 minutes ex vivo and illumina-tion with a LED blue-light (405 nm) source (BLUE-PIT®) before reinfusion to the patient. Vital signs and adverse events were regularly performed. At week 13 we assessed the patients with colonoscopy, the Harvey Bradshaw Index (HBI), the Inflammatory Bowel disease Health Related Quality of Life Questionnaire, and measurement of serum C-reactive protein, and fecal calprotec-tin (FC) levels. Biopsies of the intestines were taken for immunohistochemistry. Results: Seven patients were included. Four patients completed, with in total 24 treatments. Three of the four achieved a response, including lower HBI, FC and/or endoscopic improvement. No significant adverse events were observed. The remaining three patients received only one, three or five treatments due to technical difficulties, medical reasons, or the withdrawal of informed con-sent. Conclusion: ALA-based ECP appears safe and seem to give some clinical improvement for the patients with active CD who failed to respond to conventional and advanced therapies.

Keywords

Crohns disease, extracorporeal photopheresis, ECP, 8-MOP, UV-A, blue light.

Subject

Medicine and Pharmacology, Gastroenterology and Hepatology

Copyright: This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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