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NCT Number: NCT05594303

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

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

Guangzhou, Guangdong, 510000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • 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.

Treatment and study plan

Autologuos transplantation of bronchial basal cells

Biological

Autologuos transplantation of bronchial basal cells

Primary outcomes

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

    Time frame: Change from baseline DLCO at 3 months after transplantation

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

Secondary outcomes

  1. Forced expiratory volume in one second (FEV1)

    Time frame: Before transplantation, 3 months after transplantation, 6 months after transplantation and a year after transplantation

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

  2. Forced vital capacity (FVC)

    Time frame: Before transplantation, 3 months after transplantation, 6 months after transplantation and a year after transplantation

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

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

    Time frame: Before transplantation, 3 months after transplantation, 6 months after transplantation and a year after transplantation

    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

  4. Maximum voluntary ventilation (MVV)

    Time frame: Before transplantation, 3 months after transplantation, 6 months after transplantation and a year after transplantation

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

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

    Time frame: Before transplantation, 3 months after transplantation, 6 months after transplantation and a year after transplantation

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

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

    Time frame: Before transplantation, 3 months after transplantation, 6 months after transplantation and a year after transplantation

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

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

    Time frame: Before transplantation, 3 months after transplantation, 6 months after transplantation and a year after transplantation

    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.

  8. Chronic obstructive pulmonary disease assessment test (CAT)

    Time frame: Before transplantation, 3 months after transplantation, 6 months after transplantation and a year after transplantation

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

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

    Time frame: Change from baseline DLCO at 6 months after transplantation

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

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

    Time frame: Change from baseline DLCO at 12 months after transplantation

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

Sponsors and collaborators

Lead sponsor

Guangzhou Institute of Respiratory Disease

Other

Collaborators

  • Regend Therapeutics

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Oct 26, 2022
Registry last updated
Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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