- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03021681
An Exploratory Study on the Treatment of Chronic Obstructive Pulmonary Disease With Autologous Bronchial Basal Cell Transplantation
March 28, 2022 updated by: ZiLi Meng, Huai'an No.1 People's Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
18
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jiangsu
-
Huai'an, Jiangsu, China, 223300
- Huai'an First People's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: COPD group(self control)
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
|
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 .
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
forced expiratory volume in one second(FEV1)
Time Frame: 24 months
|
as the severity of chronic obstructive pulmonary disease(COPD)estimated by pulmonary function
|
24 months
|
chest high-resolution computed tomography
Time Frame: 24 months
|
as the severity of lung hyperinflation estimated by radiological
|
24 months
|
arterial blood gas
Time Frame: 24 months
|
to assess the level of hypoxemia and hypercapnia in chronic obstructive pulmonary disease(COPD) patients
|
24 months
|
6MWT
Time Frame: 24 months
|
6 min walking test, to evaluate the exercise function in patients with moderate and severe pulmonary heart diseases
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
forced vital capacity(FVC)
Time Frame: 24 months
|
an index of pulmonary function in chronic obstructive pulmonary disease(COPD) patients
|
24 months
|
MMRC
Time Frame: 24 months
|
an index to evaluate the lever of dyspnea
|
24 months
|
SGRQ
Time Frame: 24 months
|
a questionnaire to assess the influence of chronic airflow restriction on the quality of life, including symptoms, activities and daily life affected by diseases
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Wei Zuo, PhD, Regend Therapeutics,Suzhou Industry Park,Suzhou,CHINA
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Kumar 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.
- Rock 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2016
Primary Completion (Actual)
November 1, 2021
Study Completion (Actual)
November 1, 2021
Study Registration Dates
First Submitted
January 12, 2017
First Submitted That Met QC Criteria
January 13, 2017
First Posted (Estimate)
January 16, 2017
Study Record Updates
Last Update Posted (Actual)
March 29, 2022
Last Update Submitted That Met QC Criteria
March 28, 2022
Last Verified
August 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- Huaian1PH2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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