Lung Transplant FailureExBiomaNCT06250517
Impact of the Ex-vivo Pulmonary Perfusion System on the Microbiome of Lung Grafts and Their Inflammatory Reaction.
A study testing EVLP and Cold preservation in people with Lung Transplant Failure, run by Vall d'Hebron Institute Research at 1 site in Spain.
Trial summary
It is known that the interactions of the graft and recipient microbiome are capable of modulating immune responses, inducing resilience or exacerbation of various inflammatory or fibrotic processes, therefore variations in the lung microbiome are associated with immunological changes in the transplanted lung. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Lung Transplant Failure
- What is being tested?
- EVLP and Cold preservation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2021to Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- brain-death donors and donors after cardio circulatory death rejected for lung transplantation
Who cannot join
- Unilateral pneumonia
- Lack of consent for the donor's family.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clínic de Barcelona
Barcelona, 08036
Irene bello, Prof, +34620664172, irene.bello.rodriguez@gmail.com
Alberto Sandiumenge, Prof, +34639955585, albertosandiumenge@gmail.com
About this study
It is known that the interactions of the graft and recipient microbiome are capable of modulating immune responses, inducing resilience or exacerbation of various inflammatory or fibrotic processes, therefore variations in the lung microbiome are associated with immunological changes in the transplanted lung.
The main objective is to understand the impact of new systems for conditioning and improving suboptimal lung grafts with ex vivo perfusion(EVLP) on the lung microbiome and its association with tissue inflammation.
Read more
The hypothesis is that manipulation of lung grafts and perfusion with broad-spectrum antibiotics during EVLP conditioning changes the lung microbiome, conditioning a less pro-inflammatory environment.
The methodology: This is a single-center prospective observational study. 7 consecutive brain-dead donors who do not meet the criteria to be lung donors will be included in the study. They will be carried out:
- P1. Detection: The donor without criteria to be a lung donor or rejected by all the transplant teams.
- P2. Extraction.
- P3. Cold preservation: The left lung will be cold-preserved
- P4. EVLP Conservation: The right lung will be prepared and conditioned for 3 hours using EVLP
The following samples will be taken at two times:
- T0: At the end of the extraction
- Bronchoalveolar lavage (BAL): Before tracheal clamping, BAL will be taken from the left main bronchus using bronchoscopy. The BAL will be performed on the right lung just before starting P4.
- Lung biopsy: Lung biopsy of the lower lobe of both grafts will be performed
- Preservation liquid or Perfusion liquid: 20 mL of preservation liquid that is in contact with the left graft before storage, as a sterility control (P3) and 20 mL of perfusion liquid before conditioning, as a sterility control (P4).
- T1: At the end of the conservation protocols (P3 or P4).
- B.A.L.
- Lung biopsy: left lower lobe.
- Preservation liquid or Infusion liquid: 20 mL of preservation liquid that is in contact with the left graft or 20 mL of perfusion fluid.
Due to the manipulation of the grafts during extraction and use of the technique, which involves extubating the donor and subsequently intubated again the grafts, as well as perfusion for a minimum of 3 hours with antibiotics, the use of EVLP could alter the microbiome of the grafts. This alteration could impact the obtaining of viable organs for transplant, in the immediate postoperative period as well as in the long-term results. There are no studies that analyse the change in the microbiome after conditioning with EVLP or its relationship with inflammatory parameters.
Read the detailed description
SAMPLE TAKING AND STORAGE
- BAL:
- Technique: The bronchoscope will be inserted in segment 6, aliquots of sterile saline will be instilled. The procedure will be repeated in segments 3 and 5, in the case of the right lung, and in segment 6 and lingula in the left lung. 20-30cc of BAL will be completed for each graft.
- Storage: Samples will be frozen immediately after collection and transferred to the laboratory with a cold accumulator to ensure that they do not thaw.
- Analysis: The lung microbiome will be analysed.
- Lung biopsy:
- Technique: Lung biopsy of a minimum of 2cm3 will be taken using non-absorbable automatic suture.
- Storage: Samples will be preserved in RNA Stabilization solution Reagent (QIAGEN), which allows specimens to be kept at room temperature until frozen, avoiding RNA degradation.
- Analysis: RNA sequencing of transcription of inflammatory signals.
- Ex vivo perfusion liquid solution:
- Technique: Taking samples sterile with a 20cc syringe.
- Storage: Samples will be frozen immediately after collection and transferred to the laboratory with a cold accumulator to ensure that they do not thaw.
- Analysis: Microbiome analysis
- Preservation liquid solution:
- Technique: Taking samples sterile with a 20cc syringe.
- Storage: Samples will be frozen immediately after collection and transferred to the laboratory with a cold accumulator to ensure that they do not thaw.
- Analysis: Microbiome and cytokine analysis
All samples will be stored in a freezer at -80
- Microbiome analysis For the analysis of microbial diversity, the V4 variable region of the 16S gene will be amplified from bacterial DNA by PCR. Amplicons will be sequenced using Illumina (MiSeq) technology. Samples will be processed and more than 10,000 300bp sequences per sequence per sample will be generated.
Gene expression analysis RNA extraction will be performed using the commercial RNeasy Mini Kit (QIAGEN). Gene expression analysis will be performed by quantitative PCR (qPCR) using the predesigned TransplantRejection panel from SignArray (AnyGenes®, Paris, France) that includes 84 genes that have been described to be related to the immune response in transplant rejection. These are: Genes included in the panel: CX3CR1, ICAM1, ITGA2, ITGAE, ITGAM, PECAM1, THBS1, THBS2, VCAM1, COL1A2, CCR5, CCR7, CD40, CD40LG, CD80, CD86, CTLA4, CXCR3, STAT4, TGFB1, CD44 , CTGF, MMP1, MMP2, MMP7, MMP9, BMP7, CCL11, CCL2, CCL3, CCL4, CCL5, CSF2, CXCL10, IFNG, IL10, IL12A, IL13, IL16, IL1B, IL2, IL2RA, IL3, IL32, IL4, IL5 , IL6, IL8, TNF, TGFB2, TGFB3, TIMP1, VEGFA, MS4A1, CXCL11, CXCL9, CXCR4, ADAM17, C3, CASP1, CASP3, CASP8, CCR2, CCR3, CD14, CD28, CD8A, FAS, FASLG, FCGR1A, GZMA , GZMB, NFKB1, NOS2, PRF1, PSMB9, STAT1, STAT6, TAP1, TLR3, TLR4, TLR9, TNFAIP3, TNFSF10.
- Cytokine analysis The determination of cytokines in the perfusion fluid will be carried out using immunoassays based on Luminex™ xMAP™ technology (multi-analyte profiling) that allow the simultaneous quantification and detection of different secreted proteins (cytokines, chemokines, growth factors, etc.) We will use panels designed specifically for the gene products of interest.
Cytokine levels are measured using an immunoassay based on Luminex™ xMAP™ technology that allows for multi parametric analysis of the different cytokines. To this end, a personalized cytokine panel is designed based on the published literature on the effect of statins on the production of cytokines and other proinflammatory chemokines at a systemic level, as well as bibliographic evidence on the cytokines involved in lung transplantation. The cytokines analysed in the panel designed for this purpose are IFN gamma, IL-1 beta, IL-6, IL-8 (CXCL8), IL-18, IP-10 (CXCL10), MCP-1 (CCL2), MIP- 1 alpha (CCL3), TNF alpha, VEGF-D (Custom Procartaplex Multiplex Panel, Invitrogen, ThermoFisher Scientific, MA, USA). The immunological analysis will be carried out using the Invitrogen ProcartaPlex Analyst 1.0 software, supplied with the reagents.
- Bioinformatic analysis of the sequences To obtain the microbial composition of each sample, we will use the QIIME software. QIIME is a software pipeline that uses phylogenetic information and multivariate statistical techniques to compare microbial communities and determine, for example, whether they are statistically different. The program also identifies the species that contribute the most to these differences and discovers patterns of various types that characterize specific groups of samples.
- Conditions
- Lung Transplant Failure
- Being tested
- EVLP, Cold preservation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVLPDevice
The right lung will be perfused for 3h with EVLP
Cold preservationDevice
The left lung will be cold preserved as usual protocol
| Study group | Role | What they receive |
|---|---|---|
| EVLP | Experimental | Not described Receives: Device: EVLP |
| Cold preservation | Active comparator | Not described Receives: Device: Cold preservation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in individual operational taxonomic units (OTUs) in lung parenchyma after the exvivo lung perfusion during 3 hours
Analyse the lung microbiome and alpha diversity before the use of exvivo lung perfusion and after compared the micrological samples
Measured: After 3 hours of perfusion in ex vivo lung perfusion
Analysing with quantitative PCR of the genetic expression of 84 genes related to immune response in lung transplantation after the lung perfusion during 3h in exvivo lung perfusion system.
Analyse with quantitative PCR of the genetic expression of 84 genes related with immune response in lung transplantation: CX3CR1, ICAM1, ITGA2, ITGAE, ITGAM, PECAM1, THBS1, THBS2, VCAM1, COL1A2, CCR5, CCR7, CD40, CD40LG, CD80, CD86, CTLA4, CXCR3, STAT4, TGFB1, CD44, CTGF, MMP1, MMP2, MMP7, MMP9, BMP7, CCL11, CCL2, CCL3, CCL4, CCL5, CSF2, CXCL10, IFNG, IL10, IL12A, IL13, IL16, IL1B, IL2, IL2RA, IL3, IL32, IL4, IL5, IL6, IL8, TNF, TGFB2, TGFB3, TIMP1, VEGFA, MS4A1, CXCL11, CXCL9, CXCR4, ADAM17, C3, CASP1, CASP3, CASP8, CCR2, CCR3, CD14, CD28, CD8A, FAS, FASLG, FCGR1A, GZMA, GZMB, NFKB1, NOS2, PRF1, PSMB9, STAT1, STAT6, TAP1, TLR3, TLR4, TLR9, TNFAIP3, TNFSF10 in lung samples before the use of exvivo lung perfusion and after, comparing them
Measured: After 3 hours of perfusion in ex vivo lung perfusion
Analyse the concentration of inflammatory cytokines after exvivo lung perfusion
Analyse the concentration of inflammatory cytokines: IFN gamma,IL-1 beta,IL-6,IL-8 (CXCL8),IL-18,IP-10 (CXCL10),MCP-1 (CCL2),MIP-1 alpha (CCL3), TNF alpha,VEGF-D, with Luminex xMAP technique, in perfusion solution before and after the use of exvivo lung perfusion and comparing them
Measured: After 3 hours of perfusion in ex vivo lung perfusion
Change in individual operational taxonomic units (OTUs) in lung parenchyma after cold storage
Analyse the lung microbiome and alpha diversity before and after the cold storage and compare the micrological samples.
Measured: After 3 hours of cold storage
Analysing the concentration of inflammatory citokines after cold storage
Analyse the concentration of inflammatory cytokines: IFN gamma,IL-1 beta,IL-6,IL-8 (CXCL8),IL-18,IP-10 (CXCL10),MCP-1 (CCL2),MIP-1 alpha (CCL3), TNF alpha,VEGF-D, with Luminex xMAP technique, in perfusion solution before and after the cold storage and comparing them
Measured: After 3 hours of cold storage
Analysing with quantitative PCR of the genetic expression of 84 genes related to immune response in lung transplantation after cold storage
Analyse with quantitative PCR of the genetic expression of 84 genes related with immune response in lung transplantation: CX3CR1, ICAM1, ITGA2, ITGAE, ITGAM, PECAM1, THBS1, THBS2, VCAM1, COL1A2, CCR5, CCR7, CD40, CD40LG, CD80, CD86, CTLA4, CXCR3, STAT4, TGFB1, CD44, CTGF, MMP1, MMP2, MMP7, MMP9, BMP7, CCL11, CCL2, CCL3, CCL4, CCL5, CSF2, CXCL10, IFNG, IL10, IL12A, IL13, IL16, IL1B, IL2, IL2RA, IL3, IL32, IL4, IL5, IL6, IL8, TNF, TGFB2, TGFB3, TIMP1, VEGFA, MS4A1, CXCL11, CXCL9, CXCR4, ADAM17, C3, CASP1, CASP3, CASP8, CCR2, CCR3, CD14, CD28, CD8A, FAS, FASLG, FCGR1A, GZMA, GZMB, NFKB1, NOS2, PRF1, PSMB9, STAT1, STAT6, TAP1, TLR3, TLR4, TLR9, TNFAIP3, TNFSF10 in lung samples before and after the cold storage, comparing them
Measured: After 3 hours of cold storage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start1 Jun 2021
- Primary completionApr 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Transplant FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vall d'Hebron Institute Research
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Clinic of Barcelona
- Responsible party
- Principal investigator, Irene Bello, Vall d'Hebron Institute Research
- Investigators
- Irene Bello Rodríguez, Professor, Study director, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06250517
- Sponsor's protocol ID
- ExBioma
- Acronym
- ExBioma
- Status last verified
- Jan 2024
- First submitted
- 23 Dec 2023
- Last updated
- 9 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Ex-vivo Pulmonary Perfusion System on the Microbiome of Lung Grafts and Their Inflammatory Reaction.
- ClinicalTrials.gov ID
- NCT06250517
- Acronym / sponsor ID
- ExBioma / ExBioma
- Conditions
- Lung Transplant Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- Vall d'Hebron Institute ResearchUniversity, hospital or other
- Collaborators
- Hospital Clinic of Barcelona
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 9 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is known that the interactions of the graft and recipient microbiome are capable of modulating immune responses, inducing resilience or exacerbation of various inflammatory or fibrotic processes, therefore variations in the lung microbiome are associated with immunological changes in the transplanted lung.
The main objective is to understand the impact of new systems for conditioning and improving suboptimal lung grafts with ex vivo perfusion(EVLP) on the lung microbiome and its association with tissue inflammation.
The hypothesis is that manipulation of lung grafts and perfusion with broad-spectrum antibiotics during EVLP conditioning changes the lung microbiome, conditioning a less pro-inflammatory environment.
The methodology: This is a single-center prospective observational study. 7 consecutive brain-dead donors who do not meet the criteria to be lung donors will be included in the study. They will be carried out:
- P1. Detection: The donor without criteria to be a lung donor or rejected by all the transplant teams.
- P2. Extraction.
- P3. Cold preservation: The left lung will be cold-preserved
- P4. EVLP Conservation: The right lung will be prepared and conditioned for 3 hours using EVLP
The following samples will be taken at two times:
- T0: At the end of the extraction
- Bronchoalveolar lavage (BAL): Before tracheal clamping, BAL will be taken from the left main bronchus using bronchoscopy. The BAL will be performed on the right lung just before starting P4.
- Lung biopsy: Lung biopsy of the lower lobe of both grafts will be performed
- Preservation liquid or Perfusion liquid: 20 mL of preservation liquid that is in contact with the left graft before storage, as a sterility control (P3) and 20 mL of perfusion liquid before conditioning, as a sterility control (P4).
- T1: At the end of the conservation protocols (P3 or P4).
- B.A.L.
- Lung biopsy: left lower lobe.
- Preservation liquid or Infusion liquid: 20 mL of preservation liquid that is in contact with the left graft or 20 mL of perfusion fluid.
Due to the manipulation of the grafts during extraction and use of the technique, which involves extubating the donor and subsequently intubated again the grafts, as well as perfusion for a minimum of 3 hours with antibiotics, the use of EVLP could alter the microbiome of the grafts. This alteration could impact the obtaining of viable organs for transplant, in the immediate postoperative period as well as in the long-term results. There are no studies that analyse the change in the microbiome after conditioning with EVLP or its relationship with inflammatory parameters.
Detailed description
SAMPLE TAKING AND STORAGE
- BAL:
- Technique: The bronchoscope will be inserted in segment 6, aliquots of sterile saline will be instilled. The procedure will be repeated in segments 3 and 5, in the case of the right lung, and in segment 6 and lingula in the left lung. 20-30cc of BAL will be completed for each graft.
- Storage: Samples will be frozen immediately after collection and transferred to the laboratory with a cold accumulator to ensure that they do not thaw.
- Analysis: The lung microbiome will be analysed.
- Lung biopsy:
- Technique: Lung biopsy of a minimum of 2cm3 will be taken using non-absorbable automatic suture.
- Storage: Samples will be preserved in RNA Stabilization solution Reagent (QIAGEN), which allows specimens to be kept at room temperature until frozen, avoiding RNA degradation.
- Analysis: RNA sequencing of transcription of inflammatory signals.
- Ex vivo perfusion liquid solution:
- Technique: Taking samples sterile with a 20cc syringe.
- Storage: Samples will be frozen immediately after collection and transferred to the laboratory with a cold accumulator to ensure that they do not thaw.
- Analysis: Microbiome analysis
- Preservation liquid solution:
- Technique: Taking samples sterile with a 20cc syringe.
- Storage: Samples will be frozen immediately after collection and transferred to the laboratory with a cold accumulator to ensure that they do not thaw.
- Analysis: Microbiome and cytokine analysis
All samples will be stored in a freezer at -80
- Microbiome analysis For the analysis of microbial diversity, the V4 variable region of the 16S gene will be amplified from bacterial DNA by PCR. Amplicons will be sequenced using Illumina (MiSeq) technology. Samples will be processed and more than 10,000 300bp sequences per sequence per sample will be generated.
Gene expression analysis RNA extraction will be performed using the commercial RNeasy Mini Kit (QIAGEN). Gene expression analysis will be performed by quantitative PCR (qPCR) using the predesigned TransplantRejection panel from SignArray (AnyGenes®, Paris, France) that includes 84 genes that have been described to be related to the immune response in transplant rejection. These are: Genes included in the panel: CX3CR1, ICAM1, ITGA2, ITGAE, ITGAM, PECAM1, THBS1, THBS2, VCAM1, COL1A2, CCR5, CCR7, CD40, CD40LG, CD80, CD86, CTLA4, CXCR3, STAT4, TGFB1, CD44 , CTGF, MMP1, MMP2, MMP7, MMP9, BMP7, CCL11, CCL2, CCL3, CCL4, CCL5, CSF2, CXCL10, IFNG, IL10, IL12A, IL13, IL16, IL1B, IL2, IL2RA, IL3, IL32, IL4, IL5 , IL6, IL8, TNF, TGFB2, TGFB3, TIMP1, VEGFA, MS4A1, CXCL11, CXCL9, CXCR4, ADAM17, C3, CASP1, CASP3, CASP8, CCR2, CCR3, CD14, CD28, CD8A, FAS, FASLG, FCGR1A, GZMA , GZMB, NFKB1, NOS2, PRF1, PSMB9, STAT1, STAT6, TAP1, TLR3, TLR4, TLR9, TNFAIP3, TNFSF10.
- Cytokine analysis The determination of cytokines in the perfusion fluid will be carried out using immunoassays based on Luminex™ xMAP™ technology (multi-analyte profiling) that allow the simultaneous quantification and detection of different secreted proteins (cytokines, chemokines, growth factors, etc.) We will use panels designed specifically for the gene products of interest.
Cytokine levels are measured using an immunoassay based on Luminex™ xMAP™ technology that allows for multi parametric analysis of the different cytokines. To this end, a personalized cytokine panel is designed based on the published literature on the effect of statins on the production of cytokines and other proinflammatory chemokines at a systemic level, as well as bibliographic evidence on the cytokines involved in lung transplantation. The cytokines analysed in the panel designed for this purpose are IFN gamma, IL-1 beta, IL-6, IL-8 (CXCL8), IL-18, IP-10 (CXCL10), MCP-1 (CCL2), MIP- 1 alpha (CCL3), TNF alpha, VEGF-D (Custom Procartaplex Multiplex Panel, Invitrogen, ThermoFisher Scientific, MA, USA). The immunological analysis will be carried out using the Invitrogen ProcartaPlex Analyst 1.0 software, supplied with the reagents.
- Bioinformatic analysis of the sequences To obtain the microbial composition of each sample, we will use the QIIME software. QIIME is a software pipeline that uses phylogenetic information and multivariate statistical techniques to compare microbial communities and determine, for example, whether they are statistically different. The program also identifies the species that contribute the most to these differences and discovers patterns of various types that characterize specific groups of samples.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EVLP | Experimental | Device: EVLP |
| Cold preservation | Active comparator | Device: Cold preservation |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- brain-death donors and donors after cardio circulatory death rejected for lung transplantation
Key exclusion criteria (2 listed)
- Unilateral pneumonia
- Lack of consent for the donor's family.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EVLPThe right lung will be perfused for 3h with EVLP | Device | EVLP |
| Cold preservationThe left lung will be cold preserved as usual protocol | Device | Cold preservation |
Primary outcome
Change in individual operational taxonomic units (OTUs) in lung parenchyma after the exvivo lung perfusion during 3 hours
Time frame: After 3 hours of perfusion in ex vivo lung perfusion
Analyse the lung microbiome and alpha diversity before the use of exvivo lung perfusion and after compared the micrological samples
Analysing with quantitative PCR of the genetic expression of 84 genes related to immune response in lung transplantation after the lung perfusion during 3h in exvivo lung perfusion system.
Time frame: After 3 hours of perfusion in ex vivo lung perfusion
Analyse with quantitative PCR of the genetic expression of 84 genes related with immune response in lung transplantation: CX3CR1, ICAM1, ITGA2, ITGAE, ITGAM, PECAM1, THBS1, THBS2, VCAM1, COL1A2, CCR5, CCR7, CD40, CD40LG, CD80, CD86, CTLA4, CXCR3, STAT4, TGFB1, CD44, CTGF, MMP1, MMP2, MMP7, MMP9, BMP7, CCL11, CCL2, CCL3, CCL4, CCL5, CSF2, CXCL10, IFNG, IL10, IL12A, IL13, IL16, IL1B, IL2, IL2RA, IL3, IL32, IL4, IL5, IL6, IL8, TNF, TGFB2, TGFB3, TIMP1, VEGFA, MS4A1, CXCL11, CXCL9, CXCR4, ADAM17, C3, CASP1, CASP3, CASP8, CCR2, CCR3, CD14, CD28, CD8A, FAS, FASLG, FCGR1A, GZMA, GZMB, NFKB1, NOS2, PRF1, PSMB9, STAT1, STAT6, TAP1, TLR3, TLR4, TLR9, TNFAIP3, TNFSF10 in lung samples before the use of exvivo lung perfusion and after, comparing them
Analyse the concentration of inflammatory cytokines after exvivo lung perfusion
Time frame: After 3 hours of perfusion in ex vivo lung perfusion
Analyse the concentration of inflammatory cytokines: IFN gamma,IL-1 beta,IL-6,IL-8 (CXCL8),IL-18,IP-10 (CXCL10),MCP-1 (CCL2),MIP-1 alpha (CCL3), TNF alpha,VEGF-D, with Luminex xMAP technique, in perfusion solution before and after the use of exvivo lung perfusion and comparing them
Change in individual operational taxonomic units (OTUs) in lung parenchyma after cold storage
Time frame: After 3 hours of cold storage
Analyse the lung microbiome and alpha diversity before and after the cold storage and compare the micrological samples.
Analysing the concentration of inflammatory citokines after cold storage
Time frame: After 3 hours of cold storage
Analyse the concentration of inflammatory cytokines: IFN gamma,IL-1 beta,IL-6,IL-8 (CXCL8),IL-18,IP-10 (CXCL10),MCP-1 (CCL2),MIP-1 alpha (CCL3), TNF alpha,VEGF-D, with Luminex xMAP technique, in perfusion solution before and after the cold storage and comparing them
Analysing with quantitative PCR of the genetic expression of 84 genes related to immune response in lung transplantation after cold storage
Time frame: After 3 hours of cold storage
Analyse with quantitative PCR of the genetic expression of 84 genes related with immune response in lung transplantation: CX3CR1, ICAM1, ITGA2, ITGAE, ITGAM, PECAM1, THBS1, THBS2, VCAM1, COL1A2, CCR5, CCR7, CD40, CD40LG, CD80, CD86, CTLA4, CXCR3, STAT4, TGFB1, CD44, CTGF, MMP1, MMP2, MMP7, MMP9, BMP7, CCL11, CCL2, CCL3, CCL4, CCL5, CSF2, CXCL10, IFNG, IL10, IL12A, IL13, IL16, IL1B, IL2, IL2RA, IL3, IL32, IL4, IL5, IL6, IL8, TNF, TGFB2, TGFB3, TIMP1, VEGFA, MS4A1, CXCL11, CXCL9, CXCR4, ADAM17, C3, CASP1, CASP3, CASP8, CCR2, CCR3, CD14, CD28, CD8A, FAS, FASLG, FCGR1A, GZMA, GZMB, NFKB1, NOS2, PRF1, PSMB9, STAT1, STAT6, TAP1, TLR3, TLR4, TLR9, TNFAIP3, TNFSF10 in lung samples before and after the cold storage, comparing them
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irene Bello Rodríguez, Professor study director
Hospital Clinic of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EVLP and Cold preservation in people with Lung Transplant Failure, run by Vall d'Hebron Institute Research at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Irene Bello Rodríguez, Professor (+34620664172, irene.bello.rodriguez@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in individual operational taxonomic units (OTUs) in lung parenchyma after the exvivo lung perfusion during 3 hours (time frame: After 3 hours of perfusion in ex vivo lung perfusion). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2024.