ex Vivo Study of Liposomes Loaded With Everolimus in Chronic Lung Allograft Disfunction
NCT ID: NCT07234760
Last Updated: 2025-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
19 participants
OBSERVATIONAL
2022-03-19
2025-07-01
Brief Summary
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By this project will be exploit a liposomes preparation synthesized modifying surface with hyaluronic acid (HA), the physiologic ligand of CD44, a glycoprotein overexpressed by myofibroblasts forming fibrotic lesions. These targeted liposomes are loaded with everolimus (LIP(ev)-HA400kDa), a mTOR inhibitors already used for BOS patients but with significant side effects leading to a discontinuation of therapy. Loading everolimus inside liposomes allows the administration of drug directly to the lungs and decreases its side effects.
LIP(ev)-HA400kDa will be tested on different experimental settings: in vitro, ex vivo, in vivo. This approach will allow us to have a complete observation regarding the effects and the distribution of liposomes preparation, from the modulation of their specific targeting (myofibroblasts) by in vitro experiments, the analysis of LIP(ev)-HA400kDa behavior on human lung tissues and, finally, their ability to revert BOS in animal model.
Results obtained with this project will open to a new therapeutic option for BOS affected patients, the first therapy that can revert the disease prolonging the long-term survival of patients.
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Detailed Description
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LIP-HA400kDa fluorescently labelled will be incubated onto PCLSs derived from BOS explanted lungs comparing their distribution with LIP-PEG, using confocal microscopy. Moreover, using LIP(ev)-HA400kDa, LIP(ev) and everolimus alone we will assess general toxicity on PCLSs using LDH assay and cell proliferation with Ki67 expression at different time points. We will also assess the release of cytokines involved in pro-inflammation and pro-fibrotic processes.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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BOS
Liposomes
1. LIP(ev)-HA400kDa on lung fibroblasts derived from Broncoalvealar lavage of BOS affected patients checking key elements involved in pro-fibrotic signals in order to understand if our nanovehicle could modulate process basing fibrotic lesions production.
2. LIP(ev)-HA400kDa and fluorescent LIP-HA400kDa in PCLSs from explanted lungs by BOS patients in order to assess the cellular distribution of LIP-HA400kDa and the effect
Interventions
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Liposomes
1. LIP(ev)-HA400kDa on lung fibroblasts derived from Broncoalvealar lavage of BOS affected patients checking key elements involved in pro-fibrotic signals in order to understand if our nanovehicle could modulate process basing fibrotic lesions production.
2. LIP(ev)-HA400kDa and fluorescent LIP-HA400kDa in PCLSs from explanted lungs by BOS patients in order to assess the cellular distribution of LIP-HA400kDa and the effect
Eligibility Criteria
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Inclusion Criteria
18 Years
ALL
No
Sponsors
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Fondazione IRCCS Policlinico San Matteo di Pavia
OTHER
Responsible Party
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Mirko Belliato
Principal Investigator
Locations
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Fondazione IRCCS Policlinico San Matteo
Pavia, Lombardy, Italy
Countries
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References
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Kelsh SE, Girgis R, Dickinson M, McDermott JK. Everolimus Use for Intolerance or Failure of Baseline Immunosuppression in Adult Heart and Lung Transplantation. Ann Transplant. 2018 Oct 23;23:744-750. doi: 10.12659/AOT.910952.
Lopez P, Kohler S, Dimri S. Interstitial Lung Disease Associated with mTOR Inhibitors in Solid Organ Transplant Recipients: Results from a Large Phase III Clinical Trial Program of Everolimus and Review of the Literature. J Transplant. 2014;2014:305931. doi: 10.1155/2014/305931. Epub 2014 Dec 18.
Klawitter J, Nashan B, Christians U. Everolimus and sirolimus in transplantation-related but different. Expert Opin Drug Saf. 2015 Jul;14(7):1055-70. doi: 10.1517/14740338.2015.1040388. Epub 2015 Apr 26.
Chung PA, Dilling DF. Immunosuppressive strategies in lung transplantation. Ann Transl Med. 2020 Mar;8(6):409. doi: 10.21037/atm.2019.12.117.
Tissot A, Danger R, Claustre J, Magnan A, Brouard S. Early Identification of Chronic Lung Allograft Dysfunction: The Need of Biomarkers. Front Immunol. 2019 Jul 17;10:1681. doi: 10.3389/fimmu.2019.01681. eCollection 2019.
Verleden GM, Glanville AR, Lease ED, Fisher AJ, Calabrese F, Corris PA, Ensor CR, Gottlieb J, Hachem RR, Lama V, Martinu T, Neil DAH, Singer LG, Snell G, Vos R. Chronic lung allograft dysfunction: Definition, diagnostic criteria, and approaches to treatment-A consensus report from the Pulmonary Council of the ISHLT. J Heart Lung Transplant. 2019 May;38(5):493-503. doi: 10.1016/j.healun.2019.03.009. Epub 2019 Apr 3. No abstract available.
Mrad A, Chakraborty RK. Lung Transplant Rejection. 2022 Sep 26. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK564391/
Other Identifiers
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ELIT
Identifier Type: -
Identifier Source: org_study_id
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