BronchiectasisPhase 1/2NCT02722642
Autologous Bronchial Basal Cells Transplantation for Treatment of Bronchiectasis
A Phase 1/2 study testing Bronchial basal cells in people with Bronchiectasis, run by Regend Therapeutics at 1 site in China.
Trial summary
Bronchiectasis is a result of chronic inflammation compounded by an inability to clear mucoid secretions. Inflammation results in progressive destruction of the normal lung architecture, in particular the elastic fibers of bronchi. Currently there is no effective drug for bronchiectasis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bronchiectasis
- 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
- Mar 2016to Jun 2020
- Phase
- Phase 1/2
- 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
- Subjects diagnosed as bronchiectasis.
- Subjects with at least 6 lung segments affected.
- Subjects with stable condition for more than 2 weeks.
- Subjects can tolerate bronchoscopy.
- Subjects signed informed consent.
Who cannot join
- Women of childbearing age at the stage of pregnancy or lactation, or those without taking effective contraceptive measures.
- Subjects with syphilis or HIV positive antibody.
- Subjects with any malignancy.
- Subjects suffering from any of the following pulmonary diseases: active tuberculosis, pulmonary embolism, pneumothorax, multiple huge bullae, uncontrolled asthma, acute exacerbation of chronic bronchitis or extremely severe COPD.
- 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.
Show all 14Show fewer
- Subjects with severe renal impairment, serum creatinine> 1.5 times the upper limit of normal.
- Subjects with liver disease or liver damage: ALT, AST, total bilirubin> 2 times 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
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of the Third Military University, PLA (Southwest Hospital)
Chongqing, Chongqing Municipality, 400038
Xiaotian Dai, M.D., 86-23-68765681, daixt1973@163.com
Wei Zuo, Ph.D., 86-10-65985082, zuow@regend.cn
About this study
Official title: A Single-center, Non-randomized, Before-and-after Self Control Study of Bronchial Basal Cell Transplantation for Bronchiectasis Treatment
Bronchiectasis is a result of chronic inflammation compounded by an inability to clear mucoid secretions. Inflammation results in progressive destruction of the normal lung architecture, in particular the elastic fibers of bronchi. Currently there is no effective drug for bronchiectasis. This study intends to carry out an open, single-center, non-randomized, self control phase I/II clinical trial. During the treatment, bronchial basal cells (BCCs) will be isolated from patients' own bronchi by bronchoscopic brushing and expanded in vitro. Cultured cells 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 the key indicator-- the CT imaging of dilated bronchi as well as four secondary indicators including the pulmonary function, laboratory factor level, incidence of acute exacerbation and the patients' self-evaluation.
Read the detailed description
Bronchiectasis is a term for irreversible lung damage resulting from recurrent episodes of infection and inflammation. Bronchial basal cells (BCCs) have been proven with stem cell activity to regenerate bronchi and repair lung damage. In this single-center, non-randomized, self control phase I/II clinical trial, patients' own BCCs will be grown in laboratory before injected to the damaged part of lung tissue. Transplanted BCCs have the potential to replenish the bronchial epithelium and reconstruct respiratory architecture.
- Conditions
- Bronchiectasis
- Being tested
- Bronchial basal cells
- Medical subject headings
- Bronchiectasis
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 10^6 (1 million) /Kg/person cells of clinical grade bronchial basal cells (BBCs) injected via fiberoptic bronchoscopy after fully lavage of the localized lesions.
| Study group | Role | What they receive |
|---|---|---|
| Bronchial basal cells | Experimental | Patients will receive 10^6 (1 million)/Kg/person cells of clinical grade bronchial basal cells (BBCs) injected 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.
CT imaging of dilated bronchi
CT image of dilated bronchi will be analyzed.Clinical indicators include the spread of dilation, extent of dilation and the thickness of bronchi wall.
Measured: 3 day - 6 months
Secondary outcomes (16)
6-minute walk distance test
Measured: 3 day - 6 months
MRC chronic dyspnea scale
Measured: 3 day - 6 months
St. George's Respiratory Questionnaire (SGRQ) scale
Measured: 3 day - 6 months
inflammation indicators
TNF-α,IL1-β,PDGF,MMP9,TIMP1,CRP, PCT
Measured: 3 day - 6 months
fibrotic factor level
TGF-β, Hydroxyproline
Measured: 3 day - 6 months
incidence of acute exacerbation
Measured: 3 day-6 months
patients' self-evaluation
The self-efficacy evaluation can also be classified into four levels: effective, improved, stable and invalid.
Measured: 3 day - 6 months
blood gas level（PH）
Measured: 3 day - 6 months
blood gas level（HCO3）
Measured: 3 day - 6 months
blood gas level（PaCO2）
Measured: 3 day - 6 months
blood gas level（PaO2）
Measured: 3 day - 6 months
pulmonary function test (DLco)
Diffusing capacity of CO
Measured: 3 day - 6 months
pulmonary function test (FEV1)
Forced expiratory volume in one second, FEV1
Measured: 3 day - 6 months
pulmonary function test (FVC)
forced vital capacity
Measured: 3 day - 6 months
pulmonary function test (MVV)
maximal voluntary ventilation
Measured: 3 day - 6 months
pulmonary function test (MMEF)
maximal midexpiratory flow curve
Measured: 3 day - 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionJun 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BronchiectasisStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regend Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Southwest Hospital, China, Tongji University
- Responsible party
- Principal investigator, Xiaotian Dai, Regend Therapeutics
- Investigators
- Wei Zuo, Ph.D., Study chair, Regend Therapeutics Co.Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02722642
- Sponsor's protocol ID
- 201602301
- Status last verified
- Mar 2020
- First submitted
- 9 Mar 2016
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- 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 25383540
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Non-randomized, Before-and-after Self Control Study of Bronchial Basal Cell Transplantation for Bronchiectasis Treatment
- ClinicalTrials.gov ID
- NCT02722642
- Acronym / sponsor ID
- 201602301
- Conditions
- Bronchiectasis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Regend TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Southwest Hospital, China, Tongji University
- Study start
- Mar 2016
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 30 Mar 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.
Bronchiectasis is a result of chronic inflammation compounded by an inability to clear mucoid secretions. Inflammation results in progressive destruction of the normal lung architecture, in particular the elastic fibers of bronchi. Currently there is no effective drug for bronchiectasis. This study intends to carry out an open, single-center, non-randomized, self control phase I/II clinical trial. During the treatment, bronchial basal cells (BCCs) will be isolated from patients' own bronchi by bronchoscopic brushing and expanded in vitro. Cultured cells 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 the key indicator-- the CT imaging of dilated bronchi as well as four secondary indicators including the pulmonary function, laboratory factor level, incidence of acute exacerbation and the patients' self-evaluation.
Detailed description
Bronchiectasis is a term for irreversible lung damage resulting from recurrent episodes of infection and inflammation. Bronchial basal cells (BCCs) have been proven with stem cell activity to regenerate bronchi and repair lung damage. In this single-center, non-randomized, self control phase I/II clinical trial, patients' own BCCs will be grown in laboratory before injected to the damaged part of lung tissue. Transplanted BCCs have the potential to replenish the bronchial epithelium and reconstruct respiratory architecture.
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 10^6 (1 million)/Kg/person cells of clinical grade bronchial basal cells (BBCs) injected via fiberoptic bronchoscopy after fully lavage of the localized lesions. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects diagnosed as bronchiectasis.
- Subjects with at least 6 lung segments affected.
- Subjects with stable condition for more than 2 weeks.
- Subjects can tolerate bronchoscopy.
- Subjects signed informed consent.
Key exclusion criteria (14 listed)
- Women of childbearing age at the stage of pregnancy or lactation, or those without taking effective contraceptive measures.
- Subjects with syphilis or HIV positive antibody.
- Subjects with any malignancy.
- Subjects suffering from any of the following pulmonary diseases: active tuberculosis, pulmonary embolism, pneumothorax, multiple huge bullae, uncontrolled asthma, acute exacerbation of chronic bronchitis or extremely severe COPD.
- 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 cellsPatients will receive 10^6 (1 million) /Kg/person cells of clinical grade bronchial basal cells (BBCs) injected via fiberoptic bronchoscopy after fully lavage of the localized lesions. | Biological | Bronchial basal cells |
Primary outcome
CT imaging of dilated bronchi
Time frame: 3 day - 6 months
CT image of dilated bronchi will be analyzed.Clinical indicators include the spread of dilation, extent of dilation and the thickness of bronchi wall.
16 secondary outcomes
6-minute walk distance test
Time frame: 3 day - 6 months
MRC chronic dyspnea scale
Time frame: 3 day - 6 months
St. George's Respiratory Questionnaire (SGRQ) scale
Time frame: 3 day - 6 months
inflammation indicators
Time frame: 3 day - 6 months
fibrotic factor level
Time frame: 3 day - 6 months
incidence of acute exacerbation
Time frame: 3 day-6 months
patients' self-evaluation
Time frame: 3 day - 6 months
blood gas level（PH）
Time frame: 3 day - 6 months
blood gas level（HCO3）
Time frame: 3 day - 6 months
blood gas level（PaCO2）
Time frame: 3 day - 6 months
blood gas level（PaO2）
Time frame: 3 day - 6 months
pulmonary function test (DLco)
Time frame: 3 day - 6 months
pulmonary function test (FEV1)
Time frame: 3 day - 6 months
pulmonary function test (FVC)
Time frame: 3 day - 6 months
pulmonary function test (MVV)
Time frame: 3 day - 6 months
pulmonary function test (MMEF)
Time frame: 3 day - 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- 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.
- Individual participant dataSharing planned: No
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Bronchiectasis
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. study chair
Regend Therapeutics Co.Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Bronchial basal cells in people with Bronchiectasis, run by Regend Therapeutics 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 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 18 Mar 2020. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Wei Zuo, Ph.D. (+86-21-65985082, zuow@regend.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CT imaging of dilated bronchi (time frame: 3 day - 6 months). 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 NCT02722642, which also lists 1 linked publication.
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 18 Mar 2020.