Autologous Bronchial Basal Cells Transplantation for Treatment of Bronchiectasis

NCT02722642 | Unknown Phase 1

• 1 other identifier: 201602301
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Bronchiectasis is a result of chronic inflammation compounded by an inability to clear mucoid secretions. Inflammation results in progressive destruction of the normal lung architecture, in particular the elastic fibers of bronchi. Currently there is no effective drug for bronchiectasis. This study intends to carry out an open, single-center, non-randomized, self control phase I/II clinical trial. During the treatment, bronchial basal cells (BCCs) will be isolated from patients' own bronchi by bronchoscopic brushing and expanded in vitro. Cultured cells will be injected directly into the lesion by fiberoptic bronchoscopy after lavage. After six-month observation, the investigators will evaluate the safety and effectiveness of the treatment by measuring the key indicator-- the CT imaging of dilated bronchi as well as four secondary indicators including the pulmonary function, laboratory factor level, incidence of acute exacerbation and the patients' self-evaluation.

Conditions

Bronchiectasis

Outcome Measures

Primary Outcomes (1)

• CT imaging of dilated bronchi

  CT image of dilated bronchi will be analyzed.Clinical indicators include the spread of dilation, extent of dilation and the thickness of bronchi wall.

  3 day - 6 months

Secondary Outcomes (16)

• 6-minute walk distance test

  3 day - 6 months

• MRC chronic dyspnea scale

  3 day - 6 months

• St. George's Respiratory Questionnaire (SGRQ) scale

  3 day - 6 months

• inflammation indicators

  3 day - 6 months

• fibrotic factor level

  3 day - 6 months

Study Arms (1)

Bronchial basal cells

EXPERIMENTAL

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

Biological: Bronchial basal cells

Interventions

Bronchial basal cells BIOLOGICAL

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

Bronchial basal cells

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects diagnosed as bronchiectasis.
• Subjects with at least 6 lung segments affected.
• Subjects with stable condition for more than 2 weeks.
• Subjects can tolerate bronchoscopy.
• Subjects signed informed consent.

You may not qualify if:

• Women of childbearing age at the stage of pregnancy or lactation, or those without taking effective contraceptive measures.
• Subjects with syphilis or HIV positive antibody.
• Subjects with any malignancy.
• Subjects suffering from 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 suffering from other serious diseases, such as diabetes, myocardial infarction, unstable angina, cirrhosis, and acute glomerulonephritis.
• 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 the upper limit of normal.
• Subjects with liver disease or liver damage: ALT, AST, total bilirubin\> 2 times the upper limit of normal.
• 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.
• Subjects accepted by any other clinical trials within 3 months before the enrollment.
• Subjects with poor compliance, difficult to complete the study.
• Any other conditions that might increase the risk of subjects or interfere with the clinical trial.

Sponsors & Collaborators

• Regend Therapeutics: lead
• Southwest Hospital, China: collaborator
• Tongji University: collaborator

Study Sites (1)

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

Chongqing, Chongqing Municipality, 400038, China

RECRUITING

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: 25383540 BACKGROUND

MeSH Terms

Conditions

Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Study Officials

• Wei Zuo, Ph.D.

  Regend Therapeutics Co.Ltd

  STUDY CHAIR

Central Study Contacts

Wei Zuo, Ph.D.

CONTACT

+86-21-65985082; zuow@regend.cn

Xiaotian Dai, M.D.

CONTACT

+86-23-68765681; daixt1973@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 9, 2016
• First Posted: March 30, 2016
• Study Start: March 1, 2016
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: March 18, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)