Acute Lung Injury(ALI)NCT01373203
The Role of Fibrocytes in Acute Lung Injury
An observational study of Acute Lung Injury(ALI), run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
Trial summary
The important character of acute lung injury (ALI) is alveolar capillary membrane damage caused by different diseases, such as sepsis, trauma and shock. One of the important pathological stages is the varying degrees of interstitial fibrosis and semi-permeable alveolar membrane fibrosis. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Acute Lung Injury(ALI)
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2011to Dec 2011
- 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 20 years and older
- No healthy volunteers
- Adult, Older adult
Study population: Acute Lung Injury patients
Who may be able to join
- Acute Lung Injury patients
- Above 20 years old
- Bilateral lung infiltrates
- PaO2/FiO2<300mmHg
- PCWP<18mmHg
Who cannot join
- Pregnant women
- Under 20 years old
- Hb<8.0mg/dl
Trial locations and contacts
1 site in 1 country.
About this study
The important character of acute lung injury (ALI) is alveolar capillary membrane damage caused by different diseases, such as sepsis, trauma and shock. One of the important pathological stages is the varying degrees of interstitial fibrosis and semi-permeable alveolar membrane fibrosis. It has been proved that CXCL12/SDF-1 (stromal cell-derived factor-1) induces fibrocyte migration, and promotes fibrosis progression. Study indicated that inhibition of TLR4 receptor signaling pathway improves fibrosis progression induced by ALI, however, the role of fibrocyte in ALI is still unclear. The fibrocytes was significantly increased in asthmatic patients with pulmonary fibrosis, which companies with increased CTGF expression. Therefore, this project assumes that fibrocyte will differentiation to fibroblast/myofibroblast in patient with acute lung injury, which in turn leads to progression of fibrosis. The central hypothesis of this project is that peripheral progenitor cell fibrocytes play an important role in alveolitis caused by acute lung injury. The overall objective of this project is to study the role of fibrocytes in acute lung injury.
- Conditions
- Acute Lung Injury(ALI)
- Keywords
- Acute Lung Injury(ALI)
- Medical subject headings
- Acute Lung Injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2011 (estimated)
- Study startJan 2011
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lung Injury(ALI)Studies 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
- Observational
- Observational model
- Case only
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Kuan-Jen Bai, Principal investigator, Taipei Medical University WanFang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01373203
- Sponsor's protocol ID
- 99077
- Status last verified
- Jun 2011
- First submitted
- 13 Jun 2011
- Last updated
- 14 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Fibrocytes in Acute Lung Injury
- ClinicalTrials.gov ID
- NCT01373203
- Acronym / sponsor ID
- 99077
- Conditions
- Acute Lung Injury(ALI)
- Keywords
- Acute Lung Injury(ALI)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Study completion
- Dec 2011 (estimated)
- First posted
- 14 Jun 2011 (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.
The important character of acute lung injury (ALI) is alveolar capillary membrane damage caused by different diseases, such as sepsis, trauma and shock. One of the important pathological stages is the varying degrees of interstitial fibrosis and semi-permeable alveolar membrane fibrosis. It has been proved that CXCL12/SDF-1 (stromal cell-derived factor-1) induces fibrocyte migration, and promotes fibrosis progression. Study indicated that inhibition of TLR4 receptor signaling pathway improves fibrosis progression induced by ALI, however, the role of fibrocyte in ALI is still unclear. The fibrocytes was significantly increased in asthmatic patients with pulmonary fibrosis, which companies with increased CTGF expression. Therefore, this project assumes that fibrocyte will differentiation to fibroblast/myofibroblast in patient with acute lung injury, which in turn leads to progression of fibrosis. The central hypothesis of this project is that peripheral progenitor cell fibrocytes play an important role in alveolitis caused by acute lung injury. The overall objective of this project is to study the role of fibrocytes in acute lung injury.
Study design
- Observational model
- Case only
Who may qualify
- Ages
- 20 years and older
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute Lung Injury patients
Key inclusion criteria (5 listed)
- Acute Lung Injury patients
- Above 20 years old
- Bilateral lung infiltrates
- PaO2/FiO2<300mmHg
- PCWP<18mmHg
Key exclusion criteria (3 listed)
- Pregnant women
- Under 20 years old
- Hb<8.0mg/dl
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 14 Jun 2011.
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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.
Kuan-Jen Bai principal investigator
Taipei Medical University WanFang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Lung Injury(ALI), run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
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 5 inclusion and 3 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 14 Jun 2011. 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 Taiwan. 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?
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 14 Jun 2011.