NCT04164849

Extracorporeal Photopheresis of Patients With Crohn's Disease Using 5-aminolevulinic Acid

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: University Hospital, Akershus · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In the clinical trial the investigators will assess efficacy, safety and tolerability after single and multiple doses of 3 millimolar 5 aminolevulinic acid (Gliolan®) in combination with blue-light (405 nanometer) photopheresis in patients with active crohns disease. The study is a proof-of-concept pilot with up to 10 included patients where every patient will get active treatment. The use of 5-aminolevulinic acid in combination with blue-light photopheresis is a first-in-human trial. Primary endpoints include clinical response and adverse events (safety). Secondary endpoints include endoscopic improvement, quality of life questionnaires, faecal calprotectin, C-reactive protein and mechanisms of action (differences in t-cells and other cells before and after treatment). All patients will get treatment every 2 weeks for 10 weeks (6 treatments-induction) with evaluation at week 13. If any effect on week 13 eligible for study extension with treatment every 4 weeks for up to 12 months for the first 5 patients. The latter 5 patients will be referred to standard of care on the week 13 visit. Through the study the investigators will see if this kind of photopheresis is safe and can be an option for a larger randomized-controlled-trial. In addition the investigators will see if photopheresis as an option can be further developed for other diseases as well (ie other T-cell mediated diseases or patients already receiving photopheresis as a treatment).

Conditions

• Crohn Disease

Interventions

Type	Name	Description
DRUG	5-aminolevulinic acid	5-aminolevulinic acid (30 mg/ml) will be added to mononuclear cells in a dose of 3 millimolar and incubated for 1 hour
PROCEDURE	Blue light photopheresis	The mononuclear cells incubated with 5-aminolevulinic acid for 1 hour will be exposed to blue light.
PROCEDURE	Transfusion	The treated cells are transferred back to the patient as a standard blood transfusion
PROCEDURE	Continuous Mononuclear Cell Collection (CMNC)	The mononuclear cells are collected using the Spectra Optia with the Continuous Mononuclear Cell Collection protocol. 90 ml of mononuclear cells will be collected and 100 ml of 0,9% saline will be added to dilute the cells before incubation with drug and photopheresis.

Timeline

• Start date: 2019-11-22
• Primary completion: 2023-10-31
• Completion: 2023-10-31
• First posted: 2019-11-15
• Last updated: 2024-01-30

Locations

1 site across 1 country: Norway