Bronchial FistulaPhase 1NCT02959333
Human Amniotic Epithelial Cells for Treatment of Bronchial Fistula
A Phase 1 study testing hAEC in people with Bronchial Fistula, run by The Second Affiliated Hospital of Fujian Medical University at 1 site in China.
Trial summary
Bronchial fistula (BF), an abnormal passage or communication between a bronchus and another part of the body, may develop when there are penetrating wounds of the thorax and after lung surgery. Without effective therapy, treatment of BF is a challenge, with a high rate of mortality and teratogenicity. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bronchial Fistula
- What is being tested?
- hAEC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- Oct 2016to Dec 2017
- Phase
- Phase 1
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with bronchial fistula by Imaging or bronchoscopic examination
- typical symptom of bronchial fistula, such as fever, cough, purulent sputum, weight loss…
- patients present compromised conditions, who can only accept a conservative treatment.
Who cannot join
- absolute contraindication of bronchoscopic examination and treatment
- with previous treatment of cell therapy, including stem cells.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Fujian Medical University
Quanzhou, Fujian, 362000
Hongzhi Gao, Dr., 0595-22766122, 1564747628@qq.com
About this study
Bronchial fistula (BF), an abnormal passage or communication between a bronchus and another part of the body, may develop when there are penetrating wounds of the thorax and after lung surgery. Without effective therapy, treatment of BF is a challenge, with a high rate of mortality and teratogenicity.
The investigators will conduct endoscopic injection of human amniotic epithelial cells to fistula, observe the recovery of bronchial fistula and systemic reactions, to investigate the application of human amniotic epithelial cells in the treatment of bronchial fistula.
- Conditions
- Bronchial Fistula
- Being tested
- hAEC
- Medical subject headings
- Bronchial Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hAECBiological
hAEC: human amniotic epithelial cells
| Study group | Role | What they receive |
|---|---|---|
| hAEC treatment | Experimental | hAEC: human amniotic epithelial cells 3-5*10^7 /5 ml Receives: Biological: hAEC |
What is being measured
The primary outcome is the main question the study is designed to answer.
median time for fistula closure
Measured: 12 weeks
Secondary outcomes (1)
complication
fever, coughing up blood, infection...
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2016 (estimated)
- Study startOct 2016
- Primary completionOct 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchial FistulaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Fujian Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
- Responsible party
- Sponsor
- Investigators
- Yimin Zeng, Dr., Principal investigator, The Second Affiliated Hospital of Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02959333
- Sponsor's protocol ID
- hAEC-BF
- Status last verified
- Nov 2016
- First submitted
- 3 Nov 2016
- Last updated
- 9 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Amniotic Epithelial Cells for Treatment of Bronchial Fistula
- ClinicalTrials.gov ID
- NCT02959333
- Acronym / sponsor ID
- hAEC-BF
- Conditions
- Bronchial Fistula
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Fujian Medical UniversityUniversity, hospital or other
- Collaborators
- Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
- Study start
- Oct 2016
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 9 Nov 2016 (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.
Bronchial fistula (BF), an abnormal passage or communication between a bronchus and another part of the body, may develop when there are penetrating wounds of the thorax and after lung surgery. Without effective therapy, treatment of BF is a challenge, with a high rate of mortality and teratogenicity.
The investigators will conduct endoscopic injection of human amniotic epithelial cells to fistula, observe the recovery of bronchial fistula and systemic reactions, to investigate the application of human amniotic epithelial cells in the treatment of bronchial fistula.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hAEC treatment | Experimental | Biological: hAEChAEC: human amniotic epithelial cells 3-5*10^7 /5 ml |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with bronchial fistula by Imaging or bronchoscopic examination
- typical symptom of bronchial fistula, such as fever, cough, purulent sputum, weight loss…
- patients present compromised conditions, who can only accept a conservative treatment.
Key exclusion criteria (2 listed)
- absolute contraindication of bronchoscopic examination and treatment
- with previous treatment of cell therapy, including stem cells.
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 |
|---|---|---|
| hAEChAEC: human amniotic epithelial cells | Biological | hAEC treatment |
Primary outcome
median time for fistula closure
Time frame: 12 weeks
1 secondary outcome
complication
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2016.
- Individual participant dataSharing planned: Undecided
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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.
Yimin Zeng, Dr. principal investigator
The Second Affiliated Hospital of Fujian Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing hAEC in people with Bronchial Fistula, run by The Second Affiliated Hospital of Fujian Medical University at 1 site in China.
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 3 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 Nov 2016. 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 China. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Yimin Zeng, Dr. (0595-22766122, zeng_yi_ming@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
median time for fistula closure (time frame: 12 weeks). 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 Nov 2016.