Cell TransplantationNCT03021681
An Exploratory Study on the Treatment of Chronic Obstructive Pulmonary Disease With Autologous Bronchial Basal Cell Transplantation
A study testing autologous bronchial basal cell transplantation in people with Cell Transplantation, run by Huai'an No.1 People's Hospital at 1 site in China.
Trial summary
Chronic obstructive pulmonary disease(COPD)is characterized by recurrent cough, expectoration and asthma, and eventually develop chronic pulmonary heart disease ,chronic respiratory failure and even death. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cell Transplantation
- What is being tested?
- autologous bronchial basal cell transplantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- Nov 2016to Nov 2021
- Phase
- Interventional
- 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
- aged between 18 to 70 years
- according to the guideline criteria, the diagnosis of COPD:
- ①There is a chronic cough, sputum or gas breathing symptoms such as promoting
- ②Pulmonary function tests showed airflow limitation(FEV1<80% predicted value，FEV1/FVC<0.7)
- CT imaging and hematological examination excluded other lung diseases.
- stable disease for more than 2 weeks
- patients who were able to tolerate fiberoptic bronchoscopy
- to sign the informed consent form
Who cannot join
- women who are pregnant, nursing or not taking effective contraception
- syphilis, HIV antibody positive person
- there is a history of alcohol or illicit drug abuse
- patients who had received any other clinical trial within the first 3 months
- poor compliance, it is difficult to complete the study
- researchers believe there may be any increase in the risk of the subject or any interference with the clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Huai'an First People 's Hospital,Nanjing Medical University
Chronic obstructive pulmonary disease(COPD)is characterized by recurrent cough, expectoration and asthma, and eventually develop chronic pulmonary heart disease ,chronic respiratory failure and even death. The current clinical treatments for these patients are symptomatic treatment cannot solve the problem of the damaged lung structure fundamentally. Recent studies show that bronchial basement the layer of cells is a kind of cells in the bronchial epithelial basal layer position, the specific expression of Krt5 antigen with the regeneration and repair of lung function , these cells have the activity similar to adult tissue stem cells. Its division and migration are more active and can continue to produce new cells to complement the death of other types of epithelial cells with functional plasticity which can be used to direct repair the bronchial and alveolar structures. It has been proved that bronchial basal cell transplantation can repair the damaged lungs of experimental animals . The bronchial basal cells from autologous tissue, so there is no immune rejection problem. Also because the bronchial basal cells derived from adult tissues which is a part of the body, so there is no risk of a tumor (in animal experiments, In animal experiments, bronchial basal cells transtracheal input 100 times in human dose still no tumor formation). In the early stage, patients with COPD (2 cases), bronchiectasis (2 cases) and interstitial lung disease (1 case) received the treatment, and the overall effect was good. Diseases were alleviated and recovered to some different extend.The study was to brush bronchial basal cells through fiberbronchoscopy in COPD patients and cultured in vitro, and then through the bronchoscope transfusion to the lesion site. To preliminary evaluate the efficacy and safety of autologous bronchial basal cells in the treatment of chronic obstructive pulmonary disease.
Read the detailed description
Between November 2016 and November 2019, the investigators initially recruited 20 with stable COPD patients. Primary evaluations including medical history, physical examination, anthropometric data, blood routine, blood biochemistry, blood coagulation, electrocardiogram,high resolution chest CT, arterial blood gas, pulmonary function test,6-min walking test(6MWT),modified medical research council(MMRC),St George's respiratory questionnaire(SGRQ). After initial evaluation, the investigators obtained extraction bronchial basal cells micro tissue from 3~4 grade bronchus to by mean of fiberbronchoscopy, then purified and selectively amplified bronchial basal cells to reserve .The basal layer cell culture system for our partners (Regend Therapeutics) patented technology using culture medium containing special combination of growth factors and composite materials to simulated composite basal layer environment and can selectively amplified bronchial basal cells, while other types of mature epithelial cells and fibroblasts could not grow naturally. After a period of time, the basal lamina of the bronchial epithelial cells can be stored in the liquid nitrogen cell bank for a long time. Before applied to the patient, bronchial basal cells need to go through a series of strict examination. Then, bronchoscopy was performed again and the bronchial basal lamina suspension was injected directly into the lesion site . Estimate the change of respiratory function(symptoms, signs, chest CT, pulmonary function, the 6 minute walk test, MMRC, SGRQ etc) and serum index in third days , first months, third months, sixth months and first years of the follow-up after treatment respectively, to evaluate the safety and efficiency of autologous bronchial basal cells for treatment of COPD .
- Conditions
- Cell Transplantation
- Being tested
- autologous bronchial basal cell transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous bronchial basal cell transplantationOther
the investigators obtained extraction bronchial basal cells micro tissue from 3~4 grade bronchus, then purified and selectively amplified bronchial basal cells to reserve . After a period of time, the basal lamina of the bronchial epithelial cells can be stored in the liquid nitrogen cell bank for a long time. Before applied to the patient, bronchial basal cells need to go through a series of strict examination. Then, bronchoscopy was performed again and the bronchial basal lamina suspension was injected directly into the lesion site .
| Study group | Role | What they receive |
|---|---|---|
| COPD group(self control) | Other | Prior treatment:20 stable COPD patients were enrolled,estimated the respiratory function and serum index Intervention:autologous bronchial basal cell transplantation After treatment:Estimate the change of respiratory function and serum index in third days , first months, third months, sixth months and first years of the follow-up after treatment respectively Receives: Other: autologous bronchial basal cell transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
forced expiratory volume in one second(FEV1)
as the severity of chronic obstructive pulmonary disease(COPD)estimated by pulmonary function
Measured: 24 months
chest high-resolution computed tomography
as the severity of lung hyperinflation estimated by radiological
Measured: 24 months
arterial blood gas
to assess the level of hypoxemia and hypercapnia in chronic obstructive pulmonary disease(COPD) patients
Measured: 24 months
6MWT
6 min walking test, to evaluate the exercise function in patients with moderate and severe pulmonary heart diseases
Measured: 24 months
Secondary outcomes (3)
forced vital capacity(FVC)
an index of pulmonary function in chronic obstructive pulmonary disease(COPD) patients
Measured: 24 months
MMRC
an index to evaluate the lever of dyspnea
Measured: 24 months
SGRQ
a questionnaire to assess the influence of chronic airflow restriction on the quality of life, including symptoms, activities and daily life affected by diseases
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2017 (estimated)
- Study startNov 2016
- Primary completionNov 2021
- Study completionNov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cell TransplantationStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huai'an No.1 People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Regend Therapeutics
- Responsible party
- Principal investigator, ZiLi Meng, Huai'an No.1 People's Hospital
- Investigators
- Wei Zuo, PhD, Study chair, Regend Therapeutics,Suzhou Industry Park,Suzhou,CHINA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03021681
- Sponsor's protocol ID
- Huaian1PH2
- Status last verified
- Aug 2020
- First submitted
- 12 Jan 2017
- Last updated
- 29 Mar 2022
- 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 25383540Kumar PA, Hu Y, Yamamoto Y, Hoe NB, Wei TS, Mu D, Sun Y, Joo LS, Dagher R, Zielonka EM, Wang de Y, Lim B, Chow VT, Crum CP, Xian W, McKeon F. Distal airway stem cells yield alveoli in vitro and during lung regeneration following H1N1 influenza infection. Cell. 2011 Oct 28;147(3):525-38. doi: 10.1016/j.cell.2011.10.001.
PubMed 22036562Rock JR, Randell SH, Hogan BL. Airway basal stem cells: a perspective on their roles in epithelial homeostasis and remodeling. Dis Model Mech. 2010 Sep-Oct;3(9-10):545-56. doi: 10.1242/dmm.006031. Epub 2010 Aug 10.
PubMed 20699479
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Huai'an First People 's Hospital,Nanjing Medical University
- ClinicalTrials.gov ID
- NCT03021681
- Acronym / sponsor ID
- Huaian1PH2
- Conditions
- Cell Transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Huai'an No.1 People's HospitalUniversity, hospital or other
- Collaborators
- Regend Therapeutics
- Study start
- Nov 2016
- Primary completion
- Nov 2021 (actual)
- Study completion
- Nov 2021 (actual)
- First posted
- 16 Jan 2017 (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.
Chronic obstructive pulmonary disease(COPD)is characterized by recurrent cough, expectoration and asthma, and eventually develop chronic pulmonary heart disease ,chronic respiratory failure and even death. The current clinical treatments for these patients are symptomatic treatment cannot solve the problem of the damaged lung structure fundamentally. Recent studies show that bronchial basement the layer of cells is a kind of cells in the bronchial epithelial basal layer position, the specific expression of Krt5 antigen with the regeneration and repair of lung function , these cells have the activity similar to adult tissue stem cells. Its division and migration are more active and can continue to produce new cells to complement the death of other types of epithelial cells with functional plasticity which can be used to direct repair the bronchial and alveolar structures. It has been proved that bronchial basal cell transplantation can repair the damaged lungs of experimental animals . The bronchial basal cells from autologous tissue, so there is no immune rejection problem. Also because the bronchial basal cells derived from adult tissues which is a part of the body, so there is no risk of a tumor (in animal experiments, In animal experiments, bronchial basal cells transtracheal input 100 times in human dose still no tumor formation). In the early stage, patients with COPD (2 cases), bronchiectasis (2 cases) and interstitial lung disease (1 case) received the treatment, and the overall effect was good. Diseases were alleviated and recovered to some different extend.The study was to brush bronchial basal cells through fiberbronchoscopy in COPD patients and cultured in vitro, and then through the bronchoscope transfusion to the lesion site. To preliminary evaluate the efficacy and safety of autologous bronchial basal cells in the treatment of chronic obstructive pulmonary disease.
Detailed description
Between November 2016 and November 2019, the investigators initially recruited 20 with stable COPD patients. Primary evaluations including medical history, physical examination, anthropometric data, blood routine, blood biochemistry, blood coagulation, electrocardiogram,high resolution chest CT, arterial blood gas, pulmonary function test,6-min walking test(6MWT),modified medical research council(MMRC),St George's respiratory questionnaire(SGRQ). After initial evaluation, the investigators obtained extraction bronchial basal cells micro tissue from 3~4 grade bronchus to by mean of fiberbronchoscopy, then purified and selectively amplified bronchial basal cells to reserve .The basal layer cell culture system for our partners (Regend Therapeutics) patented technology using culture medium containing special combination of growth factors and composite materials to simulated composite basal layer environment and can selectively amplified bronchial basal cells, while other types of mature epithelial cells and fibroblasts could not grow naturally. After a period of time, the basal lamina of the bronchial epithelial cells can be stored in the liquid nitrogen cell bank for a long time. Before applied to the patient, bronchial basal cells need to go through a series of strict examination. Then, bronchoscopy was performed again and the bronchial basal lamina suspension was injected directly into the lesion site . Estimate the change of respiratory function(symptoms, signs, chest CT, pulmonary function, the 6 minute walk test, MMRC, SGRQ etc) and serum index in third days , first months, third months, sixth months and first years of the follow-up after treatment respectively, to evaluate the safety and efficiency of autologous bronchial basal cells for treatment of COPD .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD group(self control) | Other | Other: autologous bronchial basal cell transplantationPrior treatment:20 stable COPD patients were enrolled,estimated the respiratory function and serum index Intervention:autologous bronchial basal cell transplantation After treatment:Estimate the change of respiratory function and serum index in third days , first months, third months, sixth months and first years of the follow-up after treatment respectively |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- aged between 18 to 70 years
- according to the guideline criteria, the diagnosis of COPD:
- ①There is a chronic cough, sputum or gas breathing symptoms such as promoting
- ②Pulmonary function tests showed airflow limitation(FEV1<80% predicted value，FEV1/FVC<0.7)
- CT imaging and hematological examination excluded other lung diseases.
Key exclusion criteria (6 listed)
- women who are pregnant, nursing or not taking effective contraception
- syphilis, HIV antibody positive person
- there is a history of alcohol or illicit drug abuse
- patients who had received any other clinical trial within the first 3 months
- poor compliance, it is difficult to complete the study
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 |
|---|---|---|
| autologous bronchial basal cell transplantationthe investigators obtained extraction bronchial basal cells micro tissue from 3~4 grade bronchus, then purified and selectively amplified bronchial basal cells to reserve . After a period of time, the basal lamina of the bronchial epithelial cells can be stored in the liquid nitrogen cell bank for a long time. Before applied to the patient, bronchial basal cells need to go through a series of strict examination. Then, bronchoscopy was performed again and the bronchial basal lamina suspension was injected directly into the lesion site . | Other | COPD group(self control) |
Primary outcome
forced expiratory volume in one second(FEV1)
Time frame: 24 months
as the severity of chronic obstructive pulmonary disease(COPD)estimated by pulmonary function
chest high-resolution computed tomography
Time frame: 24 months
as the severity of lung hyperinflation estimated by radiological
arterial blood gas
Time frame: 24 months
to assess the level of hypoxemia and hypercapnia in chronic obstructive pulmonary disease(COPD) patients
6MWT
Time frame: 24 months
6 min walking test, to evaluate the exercise function in patients with moderate and severe pulmonary heart diseases
3 secondary outcomes
forced vital capacity(FVC)
Time frame: 24 months
MMRC
Time frame: 24 months
SGRQ
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- 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 22036562Kumar PA, Hu Y, Yamamoto Y, Hoe NB, Wei TS, Mu D, Sun Y, Joo LS, Dagher R, Zielonka EM, Wang de Y, Lim B, Chow VT, Crum CP, Xian W, McKeon F. Distal airway stem cells yield alveoli in vitro and during lung regeneration following H1N1 influenza infection. Cell. 2011 Oct 28;147(3):525-38. doi: 10.1016/j.cell.2011.10.001.
- Background: PubMed 20699479Rock JR, Randell SH, Hogan BL. Airway basal stem cells: a perspective on their roles in epithelial homeostasis and remodeling. Dis Model Mech. 2010 Sep-Oct;3(9-10):545-56. doi: 10.1242/dmm.006031. Epub 2010 Aug 10.
- 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, PhD study chair
Regend Therapeutics,Suzhou Industry Park,Suzhou,CHINA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing autologous bronchial basal cell transplantation in people with Cell Transplantation, run by Huai'an No.1 People's Hospital 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 8 inclusion and 6 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: finished, as of the sponsor's last update on 29 Mar 2022. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
forced expiratory volume in one second(FEV1) (time frame: 24 months). The study lists 4 primary outcomes in all. 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 NCT03021681, which also lists 3 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 29 Mar 2022.