NCT03156673

Brief Summary

Bronchial basal cells are proved to be able to regenerate lung structures to repair the injured lung. In COPD patients, bronchus structures are injured and cannot be repaired, which may result in the failure of pulmonary function rescue clinically.In our research, autologous bronchial basal cells will be transplanted into lung of patients suffered with COPD to treat the disease. Specifically, autologous bronchial basal cells will be dissected from brushed-off samples by bronchofiberscope. Then, they will be expanded in vitro and transplanted into lung to regenerate new alveoli and bronchus structures and re-establish pulmonary system.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P50-P75 for early_phase_1 chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Apr 2017

Longer than P75 for early_phase_1 chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

April 1, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 13, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 17, 2017

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

May 17, 2017

Status Verified

May 1, 2017

Enrollment Period

4.8 years

First QC Date

May 13, 2017

Last Update Submit

May 16, 2017

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (2)

  • Forced expiratory volume in one second (FEV1)

    An indicator for pulmonary function test to assess airway obstruction

    1-6 months

  • Forced vital capacity (FVC)

    An indicator for pulmonary function test to indicate the maximum amount of air a person can expel from the lungs after a maximum inhalation

    1-6 months

Secondary Outcomes (7)

  • Diffusion capacity of CO (DLCO)

    1-6 months

  • 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

  • 6-minute-walk test (6MWT)

    1-6 months

  • +2 more secondary outcomes

Study Arms (1)

bronchial basal cells

EXPERIMENTAL

Patients will receive of clinical grade bronchial basal cells (BBCs) with a dosage of 10\^6 (1 million) cells/Kg/person via fiberoptic bronchoscopy after fully lavage of the localized lesions.

Biological: bronchial basal cells

Interventions

bronchial basal cellsBIOLOGICAL

Patients will receive of clinical grade bronchial basal cells (BBCs) with a dosage of 10\^6 (1 million) cells/Kg/person via fiberoptic bronchoscopy after fully lavage of the localized lesions.

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;
  • Clinically stable for more than 4 weeks;
  • 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 or 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)

the First Affiliated Hospital of Shantou University Medical College

Shantou, Guangdong, 515041, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Xiaohe Zheng, M.D.

CONTACT

086-0754-8825829070229120@qq.com

Wei Zuo, Ph. D.

CONTACT

zuow@regend.cn

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

May 13, 2017

First Posted

May 17, 2017

Study Start

April 1, 2017

Primary Completion

December 31, 2021

Study Completion

June 30, 2022

Last Updated

May 17, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)