Respiratory System DefectNCT01754584
The Effect and Mechanism of Hyaluronan on the Mucociliary Differentiation of Human Respiratory Epithelial Cells
An observational study of Respiratory System Defect, run by Far Eastern Memorial Hospital.
Trial summary
The mucociliary system of nasal mucosa, which is composed of the ciliated respiratory epithelium, the mucous blanket, and the mucus-producing glands, is an important defense component of the respiratory system. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Respiratory System Defect
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jan 2009to 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: PATIENTS UNDERWENT SEPTOMEATOPLASTY
Who may be able to join
- PATIENTS UNDERWENT SEPTOMEATOPLASTY
Who cannot join
None listed.
About this study
The mucociliary system of nasal mucosa, which is composed of the ciliated respiratory epithelium, the mucous blanket, and the mucus-producing glands, is an important defense component of the respiratory system. Therefore, it is important to maintain intact inner respiratory mucociliary epithelium in reconstruction of large respiratory defect and in the development of tissue engineering trachea. Hyaluronan derivatives, which are biodegradable and non-immunogenic, have already proved to be effective as a scaffold for chondrocytes. However, the feasibility of use as a scaffold for respiratory epithelial cells remained unexplored. The aim of the study is to investigate the effect of hyaluronan including concentrations and molecular weight on the mucociliary differentiation of human respiratory epithelial cells (HREC). If hyaluronan is able to promote mucociliary differentiation of HREC, the investigators can synthesize hyaluronan derivatives serving as ideal biomaterials for respiratory tissue engineering and tissue-engineered trachea in the future.
- Conditions
- Respiratory System Defect
- Keywords
- hyaluronan including concentrations, molecular weight, mucociliary differentiation, human respiratory epithelial cells
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2012 (estimated)
- Study startJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory System DefectStudies 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
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01754584
- Sponsor's protocol ID
- FEMH 97055
- Status last verified
- Nov 2012
- First submitted
- 6 Feb 2009
- Last updated
- 21 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect and Mechanism of Hyaluronan on the Mucociliary Differentiation of Human Respiratory Epithelial Cells
- ClinicalTrials.gov ID
- NCT01754584
- Acronym / sponsor ID
- FEMH 97055
- Conditions
- Respiratory System Defect
- Keywords
- hyaluronan including concentrations, molecular weight, mucociliary differentiation, human respiratory epithelial cells
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- Jan 2009
- First posted
- 21 Dec 2012 (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 mucociliary system of nasal mucosa, which is composed of the ciliated respiratory epithelium, the mucous blanket, and the mucus-producing glands, is an important defense component of the respiratory system. Therefore, it is important to maintain intact inner respiratory mucociliary epithelium in reconstruction of large respiratory defect and in the development of tissue engineering trachea. Hyaluronan derivatives, which are biodegradable and non-immunogenic, have already proved to be effective as a scaffold for chondrocytes. However, the feasibility of use as a scaffold for respiratory epithelial cells remained unexplored. The aim of the study is to investigate the effect of hyaluronan including concentrations and molecular weight on the mucociliary differentiation of human respiratory epithelial cells (HREC). If hyaluronan is able to promote mucociliary differentiation of HREC, the investigators can synthesize hyaluronan derivatives serving as ideal biomaterials for respiratory tissue engineering and tissue-engineered trachea in the future.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- PATIENTS UNDERWENT SEPTOMEATOPLASTY
Key inclusion criteria (1 listed)
- PATIENTS UNDERWENT SEPTOMEATOPLASTY
Key exclusion criteria (0 listed)
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 21 Dec 2012.
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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 Respiratory System Defect, run by Far Eastern Memorial Hospital.
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 0 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 21 Dec 2012. 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 21 Dec 2012.