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Chronic Obstructive Pulmonary Disease (COPD)Phase 1/2NCT05594303

COPD Treatment by Transplantation of Autologous Bronchial Basal Cells

A Phase 1/2 study testing Autologuos transplantation of bronchial basal cells in people with Chronic Obstructive Pulmonary Disease (COPD), run by Guangzhou Institute of Respiratory Disease at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Chronic obstructive pulmonary disease (COPD) is a group of disease characterized by obstructed airflow. Usually, the lung structure is gradually impaired along with the progression of the disease. Recently, the treatment of disease is challenged by shortage of approaches for regenerating the injured lung tissue. Read more about this study

Who is it for?
Ages 40 to 75 years
What is being tested?
Autologuos transplantation of bronchial basal cells
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteChina
Study dates
27 Nov 2019to 18 Nov 2022
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 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. post-bronchodilator FEV1<80% predicted value;
  • Subjects with DLCO<80% predicted value in spirometry;
  • Subjects with a smoking history more than 10 pack-years (current smoker and former smoker);
  • 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 requiring anti-infection (bacteria or virus) treatment by intravenous drugs;
  • Subjects suffering from any of the following pulmonary diseases: asthma, active tuberculosis, pulmonary embolism, pneumothorax, pulmonary artery hypertension caused by other diseases;
  • Subjects with a history of invasive or non-invasive mechanical ventilation in the past 4 weeks;
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  • 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;
  • 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 allergic to products from cattle and pig;
  • 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

  • Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510000

Other trials in China

About this study

Official title: Research on Chronic Obstructive Pulmonary Disease (COPD) Treatment by Transplantation of Autologous Bronchial Basal Cells

Chronic obstructive pulmonary disease (COPD) is a group of disease characterized by obstructed airflow. Usually, the lung structure is gradually impaired along with the progression of the disease. Recently, the treatment of disease is challenged by shortage of approaches for regenerating the injured lung tissue. Here in this study, investigators intend to perform a single-centered, open, concurrent-controlled phase I/II clinical trial with autologous bronchial basal cells on COPD treatment since they were proved to regenerate lung tissue in animal models. The participants is recruited and divided into experiment group and control group. For patients from experiment group, bronchial basal cells will be isolated, expanded, carefully characterized in vitro and transplanted autologously into lung by fiberoptic bronchoscopy. No intervention is performed for patients from control group. During the study, the safety and efficacy will be evaluated on all the subjects by measuring the key indicators.

Being tested
Autologuos transplantation of bronchial basal cells
Keywords
COPD, cell therapy, bronchial basal cells, autologous transplantation
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.

  • Autologuos transplantation of bronchial basal cellsBiological

    Autologuos transplantation of bronchial basal cells

Study groups in NCT05594303
Study groupRoleWhat they receive
Bronchial basal cellsExperimentalTreatment by autologous bronchial basal cells.
Receives: Biological: Autologuos transplantation of bronchial basal cells
ControlNo interventionNo interventon.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diffusing capacity of the lung for carbon monoxide (DLCO)

    It indicates the extent to which oxygen passes from the air sacs of the lungs into the blood

    Measured: Change from baseline DLCO at 3 months after transplantation

Secondary outcomes (10)

  1. Forced expiratory volume in one second (FEV1)

    It indicates the volume of air that can forcibly be blown out in first second, after full inspiration.

    Measured: Before transplantation, 3 months after transplantation, 6 months after transplantation and a year after transplantation

  2. Forced vital capacity (FVC)

    It indicates the volume of air that can forcibly be blown out after full inspiration.

    Measured: Before transplantation, 3 months after transplantation, 6 months after transplantation and a year after transplantation

  3. The ratio of forced expiratory volume in one second to forced vital capacity (FEV1/FVC)

    It represents 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: Before transplantation, 3 months after transplantation, 6 months after transplantation and a year after transplantation

  4. Maximum voluntary ventilation (MVV)

    It indicates the maximum amount of air that can be inhaled and exhaled within one minute

    Measured: Before transplantation, 3 months after transplantation, 6 months after transplantation and a year after transplantation

  5. 6-minute-walk test (6MWT)

    An indicator to evaluate the exercise function of patients with moderate or severe pulmonary heart diseases.

    Measured: Before transplantation, 3 months after transplantation, 6 months after transplantation and a year after transplantation

  6. Imaging of lung structure by computed tomography (CT)

    Images of lung will be analyzed to indicate the newly-derived pulmonary structure.

    Measured: Before transplantation, 3 months after transplantation, 6 months after transplantation and a year after transplantation

  7. Assess life quality affected by the respiratory problem by St. George's respiratory questionnaire (SGRQ) scale

    Quality of life was assessed by St. George's respiratory questionnaire (SGRQ) scale. Total score, ranged from 0 to 100, is the sum of points from all items. A higher value represents a worse outcome.

    Measured: Before transplantation, 3 months after transplantation, 6 months after transplantation and a year after transplantation

  8. Chronic obstructive pulmonary disease assessment test (CAT)

    A patient-completed questionnaire assessing all aspects of the impact of Chronic obstructive pulmonary disease. Higher scores represent a worse outcome.

    Measured: Before transplantation, 3 months after transplantation, 6 months after transplantation and a year after transplantation

  9. Diffusing capacity of the lung for carbon monoxide (DLCO)

    It indicates the extent to which oxygen passes from the air sacs of the lungs into the blood

    Measured: Change from baseline DLCO at 6 months after transplantation

  10. Diffusing capacity of the lung for carbon monoxide (DLCO)

    It indicates the extent to which oxygen passes from the air sacs of the lungs into the blood

    Measured: Change from baseline DLCO at 12 months after transplantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2022
  2. Study start27 Nov 2019
  3. Primary completion16 May 2022
  4. Study completion18 Nov 2022

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05594303
Sponsor's protocol ID
2018001
Status last verified
Sep 2023
First submitted
26 Mar 2019
Last updated
21 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Autologuos transplantation of bronchial basal cells in people with Chronic Obstructive Pulmonary Disease (COPD), run by Guangzhou Institute of Respiratory Disease 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 7 inclusion and 17 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 21 Sep 2023. 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?

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?

Diffusing capacity of the lung for carbon monoxide (DLCO) (time frame: Change from baseline DLCO at 3 months after transplantation). 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 NCT05594303.

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 21 Sep 2023.

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