Autologous Bronchial Basal Cell Transplantation for Treatment of COPD

NCT ID: NCT03188627

Last Updated: 2023-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-12
• Study Completion Date: 2019-12-26

Brief Summary

Chronic Obstructive Pulmonary Disease (COPD) is usually characterized by long-term poor airflow, resulting in chronic pulmonary heart disease, chronic respiratory failure or even death. For COPD patients, pulmonary bronchus structures are damaged and cannot be repaired by recent clinical methods so far. This study intends to carry out a single-centered and non-randomized phase I/II clinical trial with concurrent controls to investigate whether bronchial basal cells can regenerate damaged lung tissue. During the treatment, bronchial basal cells will be isolated from patients' own bronchi and expanded in vitro. After careful characterization, expanded cells will be transplanted autologously into the lesion by fiberoptic bronchoscopy. The safety and efficacy of the treatment will be monitored by measuring the key clinical indicators.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bronchial basal cells

Transplantation of autologous bronchial basal cells

Group Type: EXPERIMENTAL

Bronchial basal cells

Intervention Type: BIOLOGICAL

Transplantation of autologous bronchial basal cells

Control

Conventional treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Bronchial basal cells

Transplantation of autologous bronchial basal cells

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Aged between 40 to 75;
• Diagnosed with COPD according the guideline (a. with symptoms of productive cough, sputum production or shortness of breath; b. with poor airflow as indicated by FEV1<70% predicted value and FEV1/FVC < 0.7 in pulmonary function test; c. with exclusion of other pulmonary disease by CT or blood examination.);
• Current smoker or ex-smoker with a history of no less than 10 years or 10 packs/year;
• Tolerant to bronchofiberscope;
• Written informed consent signed.

Exclusion Criteria

• Pregnant or lactating women;
• Patients positive for syphilis, HIV;
• Patients with malignant tumor;
• Patients with serious significant pulmonary infection and need anti-infection treatment;
• Patients with serious heart disease(NYHA class Ⅲ-Ⅳ);
• Patients with a history of abusing alcohol and illicit drug;
• Patients participated in other clinical trials in the past 3 months;
• Patients assessed as inappropriate to participate in this clinical trial by investigator.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Southwest Hospital, China

OTHER

Sponsor Role: collaborator

Tongji University

OTHER

Sponsor Role: collaborator

Regend Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Xiaotian Dai

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

First Affiliated Hospital of the Third Military University, PLA (Southwest Hospital)

Chongqing, Chongqing Municipality, China

Countries

China

References

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.

Reference Type: RESULT

PMID: 25383540 (View on PubMed)

Other Identifiers

20170206

Identifier Type: -

Identifier Source: org_study_id