Autologous Bronchial Basal Cells Transplantation for Treatment of Chronic Obstructive Pulmonary Disease (COPD)

NCT03092648 | Unknown Phase 1

• 1 other identifier: NFEC-2016-187
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic Obstructive Pulmonary Disease (COPD) is a kind of chronic bronchitis or emphysema with characteristics of long-term poor airflow, resulting in chronic pulmonary heart disease, chronic respiratory failure or even death. Anatomically, the pulmonary bronchus structures in COPD patients are damaged and cannot be repaired by recent clinical treatment so far. This study intends to carry out an open, single-armed, phase I/II clinical trial 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, cultured 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

Outcome Measures

Primary Outcomes (2)

• Forced expiratory volume in one second (FEV1)

  One of the indicators for pulmonary function

  1-6 months

• Forced vital capacity (FVC)

  One of the indicators for pulmonary function

  1-6 months

Secondary Outcomes (4)

• FEV1/FVC, MMF, MVV and DLCO

  1-6 months

• 6 minute walk test (6MWT)

  1-6 months

• MMRC

  1-6 months

• SGRQ

  1-6 months

Study Arms (2)

Bronchial basal cells

EXPERIMENTAL

Biological: Bronchial basal cell

Control

NO INTERVENTION

Interventions

Bronchial basal cell BIOLOGICAL

autologous bronchial basal cell transplantation

Bronchial basal cells

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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 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.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead
• Regend Therapeutics: collaborator
• Tongji University: collaborator

Study Sites (1)

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wei Zuo, Ph. D.

  Regend Therapeutics Co.Ltd

  STUDY CHAIR

Central Study Contacts

Guodong Hu, M.D.

CONTACT

huguodong123123@126.com

Wei Zuo, Ph. D.

CONTACT

zuow@regend.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Model Details: open, non-random, concurrent control

Study Record Dates

• First Submitted: March 22, 2017
• First Posted: March 28, 2017
• Study Start: March 1, 2017
• Primary Completion: December 30, 2018
• Study Completion: February 28, 2019
• Last Updated: March 28, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)