COPDPhase 1NCT03655795
Autologous Transplantation of Bronchial Basal Cells for Treatment of COPD
A Phase 1 study testing Bronchial basal cells in people with COPD, run by Ruijin Hospital.
Trial summary
Chronic Obstructive Pulmonary Disease (COPD) is a disease characterized by long-term poor airflow, resulting in chronic pulmonary heart disease, chronic respiratory failure or even death. Till now, the damaged pulmonary bronchus structures in COPD patients cannot be repaired by recent clinical methods so far. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- COPD
- What is being tested?
- Bronchial basal cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Nov 2018to Mar 2021
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects aged between 40 to 75.
- Subjects diagnosed with COPD and meet the following standards: a.sustained airway obstruction; b.presence of persistent airflow limitation confirmed by post-bronchodilator FEV1<70% predicted value and FEV1/FVC < 0.7.
- Subjects with pulmonary emphysema confirmed by imaging evidence.
- Subjects with DLCO<80% predicted value in pulmonary function test.
- Subjects with stable condition for more than 4 weeks.
- Subjects tolerant to bronchoscopy.
- Subjects signed informed consent.
Who cannot join
- Pregnant or lactating women.
- Subjects with syphilis or any of HIV, HBV, HCV positive antibody.
- Subjects with any malignancy.
- Subjects suffering from any of the following pulmonary diseases: asthma, active tuberculosis, pulmonary embolism, pneumothorax, pulmonary artery hypertension or interstitial lung disease.
- Subjects suffering from other serious diseases, such as diabetes, myocardial infarction, unstable angina, cirrhosis, and acute glomerulonephritis.
- Subjects with leukopenia (WBC less than 4x10^9 / L) or agranulocytosis (WBC less than 1.5x10^9 / L or neutrophils less than 0.5x10^9 / L) caused by any reason.
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- Subjects with severe renal impairment, serum creatinine> 1.5 times of the upper limit of normal.
- Subjects with liver disease or liver damage: ALT, AST, total bilirubin> 2 times of the upper limit of normal.
- Subjects with a history of mental illness or suicide risk, with a history of epilepsy or other central nervous system disorders.
- Subjects with severe arrhythmias (such as ventricular tachycardia, frequent superventricular tachycardia, atrial fibrillation, and atrial flutter, etc.) or cardiac degree II or above conduction abnormalities displayed via 12-lead ECG.
- Subjects with a history of alcohol or illicit drug abuse.
- Subjects accepted by any other clinical trials within 3 months before the enrollment.
- Subjects with poor compliance, difficult to complete the study.
- Any other conditions that might increase the risk of subjects or interfere with the clinical trial.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Autologous Transplantation of Bronchial Basal Cells for Treatment of Chronic Obstructive Pulmonary Disease (COPD)
Chronic Obstructive Pulmonary Disease (COPD) is a disease characterized by long-term poor airflow, resulting in chronic pulmonary heart disease, chronic respiratory failure or even death. Till now, the damaged pulmonary bronchus structures in COPD patients cannot be repaired by recent clinical methods so far. In this study, we intends to carry out a single-centered, non-randomized and self-controlled clinical trial at an early phase. During the process, autologous bronchial basal cells (BBCs) will be dissected from trial tissue from bronchoscopic brushing. Then the BBCs will be expanded and detected by quality control. In the following, qualified BBCs will be injected directly into the lesion by fiberoptic bronchoscopy after lavage. After six-month observation, the investigators will evaluate the safety and effectiveness of the treatment by measuring a serial of indicators, including occurrence of adverse events, pulmonary function, the CT imaging, 6 minute walk distance (6MWD), St. George's Respiratory Questionnaire (SGRQ), modified medical research council (mMRC) dyspnea scale and COPD assessment test (CAT).
- Conditions
- COPD
- 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
Autologous transplantation of bronchial basal cells
| Study group | Role | What they receive |
|---|---|---|
| Bronchial basal cells | Experimental | Autologous transplantation of bronchial basal cells Receives: Biological: Bronchial basal cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diffusing capacity of the lung for carbon monoxide (DLCO)
An indicator for pulmonary function
Measured: 6 months -1 year
Secondary outcomes (10)
Forced expiratory volume measured at the first second (FEV1)
One of the indicators in pulmonary function test, a marker to assess airway obstruction
Measured: 6 months -1 year
Forced vital capacity (FVC)
One of the indicators in pulmonary function test, indicating the maximum amount of air a person can expel from the lungs after a maximum inhalation
Measured: 6 months -1 year
The ratio of forced expiratory volume in the first one second to the forced vital capacity (FEV1/FVC)
One of the indicators in pulmonary function test, representing 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: 6 months -1 year
Maximum Mid Expiratory Flow (MMF)
One of the indicators in pulmonary function test, standing 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: 6 months -1 year
Maximum Voluntary Ventilation (MVV)
One of the indicators in pulmonary function test, measuring the maximum amount of air that can be inhaled and exhaled within one minute
Measured: 6 months -1 year
6-minute-walk test (6MWT)
An indicator to evaluate the exercise function of patients with moderate or severe pulmonary heart diseases
Measured: 6 months -1 year
Imaging of lung structure by high resolution computed tomography (HR-CT)
Images of lung will be analyzed to indicate the newly-derived pulmonary structure.
Measured: 6 months -1 year
Assess life quality affected by the respiratory problem by St. George's respiratory questionnaire (SGRQ) scale
Total scores (0-100) will be calculated and compared before and after transplantation, and higher values represent a better outcome.
Measured: 6 months -1 year
Modified medical research council (mMRC) chronic dyspnea scale to evaluate the level of dyspnea
mMRC Dyspnea Scale scores (1-5) will be measured and compared before and after transplantation, and lower values represent a better outcome.
Measured: 6 months -1 year
COPD Assessment Test (CAT)
A patient-completed questionnaire assessing all aspects of the impact of COPD
Measured: 6 months -1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study startNov 2018 (estimated)
- Primary completionSep 2020 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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
- Interventional
- Phase
- 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
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Regend Therapeutics
- Responsible party
- Principal investigator, Jieming QU, Ruijin Hospital
- Investigators
- Yun Feng, M.D., Ph.D, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03655795
- Sponsor's protocol ID
- 201809
- Status last verified
- Nov 2018
- First submitted
- 22 Aug 2018
- Last updated
- 6 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zuo W, Zhang T, Wu DZ, Guan SP, Liew AA, Yamamoto Y, Wang X, Lim SJ, Vincent M, Lessard M, Crum CP, Xian W, McKeon F. p63(+)Krt5(+) distal airway stem cells are essential for lung regeneration. Nature. 2015 Jan 29;517(7536):616-20. doi: 10.1038/nature13903. Epub 2014 Nov 12.
PubMed 25383540Ma Q, Ma Y, Dai X, Ren T, Fu Y, Liu W, Han Y, Wu Y, Cheng Y, Zhang T, Zuo W. Regeneration of functional alveoli by adult human SOX9+ airway basal cell transplantation. Protein Cell. 2018 Mar;9(3):267-282. doi: 10.1007/s13238-018-0506-y. Epub 2018 Jan 17.
PubMed 29344809
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Transplantation of Bronchial Basal Cells for Treatment of Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT03655795
- Acronym / sponsor ID
- 201809
- Conditions
- COPD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Regend Therapeutics
- Study start
- Nov 2018 (estimated)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 31 Aug 2018 (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.
Chronic Obstructive Pulmonary Disease (COPD) is a disease characterized by long-term poor airflow, resulting in chronic pulmonary heart disease, chronic respiratory failure or even death. Till now, the damaged pulmonary bronchus structures in COPD patients cannot be repaired by recent clinical methods so far. In this study, we intends to carry out a single-centered, non-randomized and self-controlled clinical trial at an early phase. During the process, autologous bronchial basal cells (BBCs) will be dissected from trial tissue from bronchoscopic brushing. Then the BBCs will be expanded and detected by quality control. In the following, qualified BBCs will be injected directly into the lesion by fiberoptic bronchoscopy after lavage. After six-month observation, the investigators will evaluate the safety and effectiveness of the treatment by measuring a serial of indicators, including occurrence of adverse events, pulmonary function, the CT imaging, 6 minute walk distance (6MWD), St. George's Respiratory Questionnaire (SGRQ), modified medical research council (mMRC) dyspnea scale and COPD assessment test (CAT).
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 cellsAutologous transplantation of bronchial basal cells |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects aged between 40 to 75.
- Subjects diagnosed with COPD and meet the following standards: a.sustained airway obstruction; b.presence of persistent airflow limitation confirmed by post-bronchodilator FEV1<70% predicted value and FEV1/FVC < 0.7.
- Subjects with pulmonary emphysema confirmed by imaging evidence.
- Subjects with DLCO<80% predicted value in pulmonary function test.
- Subjects with stable condition for more than 4 weeks.
Key exclusion criteria (14 listed)
- Pregnant or lactating women.
- Subjects with syphilis or any of HIV, HBV, HCV positive antibody.
- Subjects with any malignancy.
- Subjects suffering from any of the following pulmonary diseases: asthma, active tuberculosis, pulmonary embolism, pneumothorax, pulmonary artery hypertension or interstitial lung disease.
- Subjects suffering from other serious diseases, such as diabetes, myocardial infarction, unstable angina, cirrhosis, and acute glomerulonephritis.
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 cellsAutologous transplantation of bronchial basal cells | Biological | Bronchial basal cells |
Primary outcome
Diffusing capacity of the lung for carbon monoxide (DLCO)
Time frame: 6 months -1 year
An indicator for pulmonary function
10 secondary outcomes
Forced expiratory volume measured at the first second (FEV1)
Time frame: 6 months -1 year
Forced vital capacity (FVC)
Time frame: 6 months -1 year
The ratio of forced expiratory volume in the first one second to the forced vital capacity (FEV1/FVC)
Time frame: 6 months -1 year
Maximum Mid Expiratory Flow (MMF)
Time frame: 6 months -1 year
Maximum Voluntary Ventilation (MVV)
Time frame: 6 months -1 year
6-minute-walk test (6MWT)
Time frame: 6 months -1 year
Imaging of lung structure by high resolution computed tomography (HR-CT)
Time frame: 6 months -1 year
Assess life quality affected by the respiratory problem by St. George's respiratory questionnaire (SGRQ) scale
Time frame: 6 months -1 year
Modified medical research council (mMRC) chronic dyspnea scale to evaluate the level of dyspnea
Time frame: 6 months -1 year
COPD Assessment Test (CAT)
Time frame: 6 months -1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2018.
- Background: PubMed 25383540Zuo W, Zhang T, Wu DZ, Guan SP, Liew AA, Yamamoto Y, Wang X, Lim SJ, Vincent M, Lessard M, Crum CP, Xian W, McKeon F. p63(+)Krt5(+) distal airway stem cells are essential for lung regeneration. Nature. 2015 Jan 29;517(7536):616-20. doi: 10.1038/nature13903. Epub 2014 Nov 12.
- Background: PubMed 29344809Ma Q, Ma Y, Dai X, Ren T, Fu Y, Liu W, Han Y, Wu Y, Cheng Y, Zhang T, Zuo W. Regeneration of functional alveoli by adult human SOX9+ airway basal cell transplantation. Protein Cell. 2018 Mar;9(3):267-282. doi: 10.1007/s13238-018-0506-y. Epub 2018 Jan 17.
- 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.
Yun Feng, M.D., Ph.D principal investigator
Ruijin Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bronchial basal cells in people with COPD, run by Ruijin 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 7 inclusion and 14 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 6 Nov 2018. 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.
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 Jieming Qu, M.D., Ph.D (+86-21-64370045, jmqu0906@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diffusing capacity of the lung for carbon monoxide (DLCO) (time frame: 6 months -1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03655795, which also lists 2 linked publications.
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 6 Nov 2018.