NCT03188627

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Jun 2018

Typical duration for phase_1 chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 15, 2017

Completed
12 months until next milestone

Study Start

First participant enrolled

June 12, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 26, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 26, 2019

Completed
Last Updated

March 24, 2023

Status Verified

March 1, 2023

Enrollment Period

1.5 years

First QC Date

June 13, 2017

Last Update Submit

March 23, 2023

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (2)

  • Indicators for safety

    Measured by blood routine test, urine routine test and blood chemistry panels

    1-6 months

  • Diffusion capacity of CO (DLCO)

    One of the indicators in pulmonary function test, the extent to which oxygen passes from the air sacs of the lungs into the blood

    1-6 months

Secondary Outcomes (9)

  • The ratio of forced expiratory volume in the first one second to the forced vital capacity (FEV1/FVC)

    1-6 months

  • Maximum mid-expiratory flow (MMF)

    1-6 months

  • Maximum voluntary ventilation (MVV)

    1-6 months

  • Forced expiratory volume in one second (FEV1)

    1-6 months

  • 6-minute-walk test (6MWT)

    1-6 months

  • +4 more secondary outcomes

Study Arms (2)

Bronchial basal cells

EXPERIMENTAL

Transplantation of autologous bronchial basal cells

Biological: Bronchial basal cells

Control

NO INTERVENTION

Conventional treatment

Interventions

Bronchial basal cellsBIOLOGICAL

Transplantation of autologous bronchial basal cells

Bronchial basal cells

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged between 40 to 75;
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Chongqing, Chongqing Municipality, 400038, China

Location

Related Publications (1)

  • 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.

    PMID: 25383540RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

June 13, 2017

First Posted

June 15, 2017

Study Start

June 12, 2018

Primary Completion

December 26, 2019

Study Completion

December 26, 2019

Last Updated

March 24, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)