Follow-up Study of Autologous Transplantation of P63+ Lung Progenitor Cells for Treatment of Bronchiectasis
Key facts
- Who runs it
- Ruijin Hospital
- Where
- China1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 12 people enrolled
- Started
- 12 Dec 2023
- Ended
- 31 Jan 2024
- Type of study
- Interventional, 2 groups
- Treatments tested
- RNA sequencing is performed on the remaining LPCs
- Immunofluorescence staining is performed in the surgically resected lung tissue sections
- Record updated
- 9 October 2024
Who can take part
- Age
- 18 years to 75 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 31 criteriaShow less
Who can take part
- Subjects diagnosed as bronchiectasis
- Subjects have participated in the clinical trial of autologous transplantation of P63+ LPCs for treatment of bronchiectasis, and actually received LPCs transplantation treatment
- Subjects with stable condition for more than 2 weeks
- Subjects can tolerate bronchoscopy
- Subjects signed informed consent
- Subjects with good compliance
- Subjects diagnosed as bronchiectasis
- Subjects have never participated in the clinical trial of autologous transplantation of P63+ LPCs for treatment of bronchiectasis, and never received LPCs transplantation treatment
- Subjects have once received surgery to remove bronchiectasis lesions and lung samples are still kept in the Department of Pathology, Ruijin Hospital till now
- Subjects signed informed consent
Who cannot take part
- Subjects accepted by any other clinical trials within 3 months before the enrollment
- Subjects accepted by any other clinical trials within 3 months before the enrollment
- Subjects with positive serological tests for hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or syphilis (HBV carriers and patients with stable chronic hepatitis B could be accepted if titers of HBV DNA < 500 IU/mL or copies < 1000 copies/mL; patients with curative hepatitis C were eligible if HCV RNA tests were negative)
- Subjects with any malignancy
- Subjects with any of the following pulmonary diseases: active tuberculosis, pulmonary embolism, pneumothorax, multiple huge bullae, uncontrolled asthma, acute exacerbation of chronic bronchitis or extremely severe chronic obstructive pulmonary disease (COPD)
- Subjects with other serious diseases, such as diabetes, myocardial infarction, unstable angina, cirrhosis, and acute glomerulonephritis
- 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
- Any other conditions that might increase the risk of subjects or interfere with the clinical trial; Subjects providing samples of surgically resected bronchiectasis lesions
- Subjects with positive serological tests for hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or syphilis (HBV carriers and patients with stable chronic hepatitis B could be accepted if titers of HBV DNA < 500 IU/mL or copies < 1000 copies/mL; patients with curative hepatitis C were eligible if HCV RNA tests were negative)
- Subjects with any malignancy
- Subjects with 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 with a history of alcohol or illicit drug abuse
- 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: alanine transaminase (ALT), aspartate transaminase (AST), total bilirubin> 2 times of the upper limit of normal
- Women of childbearing age at the stage of pregnancy or lactation, or those without taking effective contraceptive measures
- Women of childbearing age at the stage of pregnancy or lactation, or those without taking effective contraceptive measures
- Subjects with poor compliance, difficult to complete the study
Other criteria
- Subjects once received cell treatment
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
This is the follow-up study of autologous transplantation of P63+ lung progenitor cells (LPCs) for treatment of bronchiectasis (NCT03655808). Bronchiectasis is the consequence of chronic suppurative inflammation and fibrosis of the bronchial tubes and the surrounding lung tissues. This seriously damages the muscular and elastic tissues of the bronchial walls, leading to deformation and permanent dilatation of the bronchial tubes. Histopathological damage to the patient's lungs is irremediable. However, there is no effective drug for rebuilding the damaged lung tissue structure, and thus cannot fully restore normal lung function. Lung progenitor cells, located in the basal position of the bronchial epithelium, express the P63 and Keratin-5 (KRT5) marker genes. These cells are active in division and migration, continuously generating new cells to replace other types of dead epithelial cells. They exhibit functional plasticity and can directly repair bronchial and alveolar structures. P63+ LPCs can be extracted by fibreoptic brushing and then isolated, purified and expanded on a large scale using appropriate methods. Currently, preclinical studies and some pilot clinical trials have shown that these cells can successfully repair damaged lungs, improve lung function and have a favourable safety profile. To further investigate the therapeutic mechanism of P63+ LPCs, RNA sequencing will be performed on the remaining LPCs previously transplanted back into the patients. Additionally, to confirm the existence of LPCs in the lung tissue of bronchiectasis patients, the pathological sections of lung tissue samples from patients who had received surgical resection of the lesions, will be subjected to fluorescence staining.
The 2 groups in the trial
- Subjects once received LPCs transplantation treatmentOther group
The patients who have participated in the clinical trial of autologous transplantation of P63+ LPCs for treatment of bronchiectasis, and actually received LPCs transplantation treatment. (n = 15)
Treatment: RNA sequencing is performed on the remaining LPCs
- Subjects providing samples of surgically resected bronchiectasis lesionsOther group
The bronchiectasis patients who could provide samples of surgically resected lung lesions. (n = 5)
Treatment: Immunofluorescence staining is performed in the surgically resected lung tissue sections
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 9 October 2024