Liver TransplantationNCT01117077
The Immune Tolerance Mechanism Induced by IL-17-producing Regulatory T Cells in the Orthotopic Liver Transplant Recipients With Aspergillosis
An observational study of Liver Transplantation and Aspergillus, run by Shanghai Jiao Tong University School of Medicine.
Trial summary
Infection accounted for the first cause of death in patients after liver transplantation, and 2 / 3 of the cause of death was fungal infections. The investigators group early found that T cell subsets playing a role of inducing immune tolerance were significantly increased in vivo of liver transplantation patients… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Liver Transplantation, Aspergillus, Interleukin-17
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- May 2010to not given
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: liver transplantation patients with aspergillus infection or without aspergillus infection
Who may be able to join
- Liver transplantation patients
Who cannot join
- Psychopath
About this study
Infection accounted for the first cause of death in patients after liver transplantation, and 2 / 3 of the cause of death was fungal infections. The investigators group early found that T cell subsets playing a role of inducing immune tolerance were significantly increased in vivo of liver transplantation patients with aspergillus infection, which may be a kind of Treg cells expressing IL-17. To explore the immune tolerance mechanism induced by the immune balance cells is important to liver transplantation patients for improving efficacy and reducing the mortality. Therefore, the investigators are going to get the blood sample and liver tissue of the liver transplantation patients before and after treatment of aspergillus infection, flow cytometry analysis of blood T cell subsets, Cytometric Bead Array to detect changes in blood cytokines, laser capture microdissection to obtain liver biopsies of inflammatory cells in portal area and further for analysis of T cell subsets and protein. And the investigators are also to investigate the characteristics of CCR6 + CD4 + FOXP3 + Treg cell clones secreting IL-17 and the capacity of which suppressing conventional T cell proliferation. This study may find new methods, such as certain types of T cell subsets or cytokines for the treatment of liver transplant patients, which not only to anti-rejection but also to reduce fungal infection.
- Conditions
- Liver Transplantation, Aspergillus, Interleukin-17, Treg Cell, Immune Tolerance
- Keywords
- liver transplantation, aspergillus infection, interleukin-17, Treg cell, immune tolerance
- Medical subject headings
- Aspergillosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2010 (estimated)
- Study startMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01117077
- Sponsor's protocol ID
- 10ZR1423900
- Status last verified
- May 2010
- First submitted
- 4 May 2010
- Last updated
- 5 May 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Immune Tolerance Mechanism Induced by IL-17-producing Regulatory T Cells in the Orthotopic Liver Transplant Recipients With Aspergillosis
- ClinicalTrials.gov ID
- NCT01117077
- Acronym / sponsor ID
- 10ZR1423900
- Conditions
- Liver Transplantation, Aspergillus, Interleukin-17, Treg Cell, Immune Tolerance
- Keywords
- liver transplantation, aspergillus infection, interleukin-17, Treg cell, immune tolerance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- May 2010
- First posted
- 5 May 2010 (estimated)
- 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.
Infection accounted for the first cause of death in patients after liver transplantation, and 2 / 3 of the cause of death was fungal infections. The investigators group early found that T cell subsets playing a role of inducing immune tolerance were significantly increased in vivo of liver transplantation patients with aspergillus infection, which may be a kind of Treg cells expressing IL-17. To explore the immune tolerance mechanism induced by the immune balance cells is important to liver transplantation patients for improving efficacy and reducing the mortality. Therefore, the investigators are going to get the blood sample and liver tissue of the liver transplantation patients before and after treatment of aspergillus infection, flow cytometry analysis of blood T cell subsets, Cytometric Bead Array to detect changes in blood cytokines, laser capture microdissection to obtain liver biopsies of inflammatory cells in portal area and further for analysis of T cell subsets and protein. And the investigators are also to investigate the characteristics of CCR6 + CD4 + FOXP3 + Treg cell clones secreting IL-17 and the capacity of which suppressing conventional T cell proliferation. This study may find new methods, such as certain types of T cell subsets or cytokines for the treatment of liver transplant patients, which not only to anti-rejection but also to reduce fungal infection.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- liver transplantation patients with aspergillus infection or without aspergillus infection
Key inclusion criteria (1 listed)
- Liver transplantation patients
Key exclusion criteria (1 listed)
- Psychopath
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplantation and Aspergillus, run by Shanghai Jiao Tong University School of Medicine.
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 1 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 5 May 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 5 May 2010.