Chronic Obstructive Pulmonary DiseaseEarly Phase 1NCT03156673
Treatment of COPD by Autologous Transplantation of Bronchial Basal Cells
A Early Phase 1 study testing bronchial basal cells in people with Chronic Obstructive Pulmonary Disease, run by First Affiliated Hospital of Shantou University Medical College at 1 site in China.
Trial summary
Bronchial basal cells are proved to be able to regenerate lung structures to repair the injured lung. In COPD patients, bronchus structures are injured and cannot be repaired, which may result in the failure of pulmonary function rescue clinically.In our research, autologous bronchial basal cells will be transplanted… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- bronchial basal cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2017to 30 Jun 2022
- Phase
- Early 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 40 to 75;
- Diagnosed with COPD according the guideline (a. with symptoms of productive cough, sputum production or shortness of breath; b. with poor airflow as indicated by FEV1<70% predicted value and FEV1/FVC < 0.7 in pulmonary function test; c. with exclusion of other pulmonary disease by CT or blood examination);
- Clinically stable for more than 4 weeks;
- Tolerant to bronchofiberscope;
- Written informed consent signed.
Who cannot join
- Pregnant or lactating women;
- Patients positive for syphilis, HIV;
- Patients with malignant tumor;
- Patients with serious or significant pulmonary infection and need anti-infection treatment;
- Patients with serious heart disease(NYHA class Ⅲ-Ⅳ);
- Patients with a history of abusing alcohol and illicit drug;
- Patients participated in other clinical trials in the past 3 months;
- Patients assessed as inappropriate to participate in this clinical trial by investigator.
Trial locations and contacts
1 site in 1 country.
Wei Zuo, Ph. D. contact
China1 site, 1 recruiting
- Recruiting
the First Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong, 515041
Xiaohe Zheng, M. D., 086-0754-88258290, 70229120@qq.com
Xiaohe Zheng, M. D.
About this study
Official title: Primary Research on Treatment of Chronic Obstructive Pulmonary Disease (COPD) by Transplantation of Autologous Bronchial Basal Cells
Bronchial basal cells are proved to be able to regenerate lung structures to repair the injured lung. In COPD patients, bronchus structures are injured and cannot be repaired, which may result in the failure of pulmonary function rescue clinically.In our research, autologous bronchial basal cells will be transplanted into lung of patients suffered with COPD to treat the disease. Specifically, autologous bronchial basal cells will be dissected from brushed-off samples by bronchofiberscope. Then, they will be expanded in vitro and transplanted into lung to regenerate new alveoli and bronchus structures and re-establish pulmonary system.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- bronchial basal cells
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bronchial basal cellsBiological
Patients will receive of clinical grade bronchial basal cells (BBCs) with a dosage of 10^6 (1 million) cells/Kg/person via fiberoptic bronchoscopy after fully lavage of the localized lesions.
| Study group | Role | What they receive |
|---|---|---|
| bronchial basal cells | Experimental | Patients will receive of clinical grade bronchial basal cells (BBCs) with a dosage of 10^6 (1 million) cells/Kg/person via fiberoptic bronchoscopy after fully lavage of the localized lesions. Receives: Biological: bronchial basal cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced expiratory volume in one second (FEV1)
An indicator for pulmonary function test to assess airway obstruction
Measured: 1-6 months
Forced vital capacity (FVC)
An indicator for pulmonary function test to indicate the maximum amount of air a person can expel from the lungs after a maximum inhalation
Measured: 1-6 months
Secondary outcomes (7)
Diffusion capacity of CO (DLCO)
An indicator for pulmonary function test to show the extent to which oxygen passes from the air sacs of the lungs into the blood
Measured: 1-6 months
The ratio of forced expiratory volume in the first one second to the forced vital capacity (FEV1/FVC)
An indicator in pulmonary function test to represent the proportion of a person's vital capacity that they are able to expire in the first second of forced expiration to the full vital capacity
Measured: 1-6 months
Maximum mid-expiratory flow (MMF)
An indicator in pulmonary function test to stand for maximal (mid-)expiratory flow and is the peak of expiratory flow as taken from the flow-volume curve and measured in liters per second
Measured: 1-6 months
Maximum voluntary ventilation (MVV)
An indicator in pulmonary function test to measure the maximum amount of air that can be inhaled and exhaled within one minute
Measured: 1-6 months
6-minute-walk test (6MWT)
An indicator to evaluate the exercise function of patients with moderate or severe pulmonary heart diseases
Measured: 1-6 months
Modified medical research council (MMRC) chronic dyspnea scale
An indicator to evaluate the level of dyspnea
Measured: 1-6 months
St. George's respiratory questionnaire (SGRQ) scale
A questionnaire to assess life quality affected by the respiratory problems
Measured: 1-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start1 Apr 2017
- Primary completion31 Dec 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Shantou University Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- Regend Therapeutics, Tongji University
- Responsible party
- Principal investigator, Xiaohe Zheng, First Affiliated Hospital of Shantou University Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03156673
- Sponsor's protocol ID
- 2017112
- Status last verified
- May 2017
- First submitted
- 13 May 2017
- Last updated
- 17 May 2017
- 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 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Research on Treatment of Chronic Obstructive Pulmonary Disease (COPD) by Transplantation of Autologous Bronchial Basal Cells
- ClinicalTrials.gov ID
- NCT03156673
- Acronym / sponsor ID
- 2017112
- Conditions
- Chronic Obstructive Pulmonary Disease
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Shantou University Medical CollegeUniversity, hospital or other
- Collaborators
- Regend Therapeutics, Tongji University
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 17 May 2017 (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.
Bronchial basal cells are proved to be able to regenerate lung structures to repair the injured lung. In COPD patients, bronchus structures are injured and cannot be repaired, which may result in the failure of pulmonary function rescue clinically.In our research, autologous bronchial basal cells will be transplanted into lung of patients suffered with COPD to treat the disease. Specifically, autologous bronchial basal cells will be dissected from brushed-off samples by bronchofiberscope. Then, they will be expanded in vitro and transplanted into lung to regenerate new alveoli and bronchus structures and re-establish pulmonary system.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| bronchial basal cells | Experimental | Biological: bronchial basal cellsPatients will receive of clinical grade bronchial basal cells (BBCs) with a dosage of 10^6 (1 million) cells/Kg/person via fiberoptic bronchoscopy after fully lavage of the localized lesions. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged between 40 to 75;
- Diagnosed with COPD according the guideline (a. with symptoms of productive cough, sputum production or shortness of breath; b. with poor airflow as indicated by FEV1<70% predicted value and FEV1/FVC < 0.7 in pulmonary function test; c. with exclusion of other pulmonary disease by CT or blood examination);
- Clinically stable for more than 4 weeks;
- Tolerant to bronchofiberscope;
- Written informed consent signed.
Key exclusion criteria (8 listed)
- Pregnant or lactating women;
- Patients positive for syphilis, HIV;
- Patients with malignant tumor;
- Patients with serious or significant pulmonary infection and need anti-infection treatment;
- Patients with serious heart disease(NYHA class Ⅲ-Ⅳ);
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 |
|---|---|---|
| bronchial basal cellsPatients will receive of clinical grade bronchial basal cells (BBCs) with a dosage of 10^6 (1 million) cells/Kg/person via fiberoptic bronchoscopy after fully lavage of the localized lesions. | Biological | bronchial basal cells |
Primary outcome
Forced expiratory volume in one second (FEV1)
Time frame: 1-6 months
An indicator for pulmonary function test to assess airway obstruction
Forced vital capacity (FVC)
Time frame: 1-6 months
An indicator for pulmonary function test to indicate the maximum amount of air a person can expel from the lungs after a maximum inhalation
7 secondary outcomes
Diffusion capacity of CO (DLCO)
Time frame: 1-6 months
The ratio of forced expiratory volume in the first one second to the forced vital capacity (FEV1/FVC)
Time frame: 1-6 months
Maximum mid-expiratory flow (MMF)
Time frame: 1-6 months
Maximum voluntary ventilation (MVV)
Time frame: 1-6 months
6-minute-walk test (6MWT)
Time frame: 1-6 months
Modified medical research council (MMRC) chronic dyspnea scale
Time frame: 1-6 months
St. George's respiratory questionnaire (SGRQ) scale
Time frame: 1-6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2017.
- 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.
Wei Zuo, Ph. D. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing bronchial basal cells in people with Chronic Obstructive Pulmonary Disease, run by First Affiliated Hospital of Shantou University Medical College 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 5 inclusion and 8 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 17 May 2017. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Xiaohe Zheng, M.D. (086-0754-88258290, 70229120@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced expiratory volume in one second (FEV1) (time frame: 1-6 months). The study lists 2 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 17 May 2017.