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Autologous Bronchial Basal Cells Transplantation for Treatment of Bronchiectasis

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ClinicalTrials.gov Identifier: NCT02722642
Recruitment Status : Recruiting
First Posted : March 30, 2016
Last Update Posted : August 31, 2018
Sponsor:
Collaborators:
Southwest Hospital, China
Tongji University
Information provided by (Responsible Party):
Xiaotian Dai, Regend Therapeutics

Tracking Information
First Submitted Date  ICMJE March 9, 2016
First Posted Date  ICMJE March 30, 2016
Last Update Posted Date August 31, 2018
Study Start Date  ICMJE March 2016
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 29, 2016)
CT imaging of dilated bronchi [ Time Frame: 3 day - 6 months ]
CT image of dilated bronchi will be analyzed.Clinical indicators include the spread of dilation, extent of dilation and the thickness of bronchi wall.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02722642 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 29, 2016)
  • 6-minute walk distance test [ Time Frame: 3 day - 6 months ]
  • MRC chronic dyspnea scale [ Time Frame: 3 day - 6 months ]
  • St. George's Respiratory Questionnaire (SGRQ) scale [ Time Frame: 3 day - 6 months ]
  • inflammation indicators [ Time Frame: 3 day - 6 months ]
    TNF-α,IL1-β,PDGF,MMP9,TIMP1,CRP, PCT
  • fibrotic factor level [ Time Frame: 3 day - 6 months ]
    TGF-β, Hydroxyproline
  • incidence of acute exacerbation [ Time Frame: 3 day-6 months ]
  • patients' self-evaluation [ Time Frame: 3 day - 6 months ]
    The self-efficacy evaluation can also be classified into four levels: effective, improved, stable and invalid.
  • blood gas level(PH) [ Time Frame: 3 day - 6 months ]
  • blood gas level(HCO3) [ Time Frame: 3 day - 6 months ]
  • blood gas level(PaCO2) [ Time Frame: 3 day - 6 months ]
  • blood gas level(PaO2) [ Time Frame: 3 day - 6 months ]
  • pulmonary function test (DLco) [ Time Frame: 3 day - 6 months ]
    Diffusing capacity of CO
  • pulmonary function test (FEV1) [ Time Frame: 3 day - 6 months ]
    Forced expiratory volume in one second, FEV1
  • pulmonary function test (FVC) [ Time Frame: 3 day - 6 months ]
    forced vital capacity
  • pulmonary function test (MVV) [ Time Frame: 3 day - 6 months ]
    maximal voluntary ventilation
  • pulmonary function test (MMEF) [ Time Frame: 3 day - 6 months ]
    maximal midexpiratory flow curve
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Autologous Bronchial Basal Cells Transplantation for Treatment of Bronchiectasis
Official Title  ICMJE A Single-center, Non-randomized, Before-and-after Self Control Study of Bronchial Basal Cell Transplantation for Bronchiectasis Treatment
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.
Detailed Description Bronchiectasis is a term for irreversible lung damage resulting from recurrent episodes of infection and inflammation. Bronchial basal cells (BCCs) have been proven with stem cell activity to regenerate bronchi and repair lung damage. In this single-center, non-randomized, self control phase I/II clinical trial, patients' own BCCs will be grown in laboratory before injected to the damaged part of lung tissue. Transplanted BCCs have the potential to replenish the bronchial epithelium and reconstruct respiratory architecture.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Bronchiectasis
Intervention  ICMJE Biological: Bronchial basal cells
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.
Study Arms  ICMJE Experimental: Bronchial basal cells
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.
Intervention: Biological: Bronchial basal cells
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 29, 2016)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2020
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Wei Zuo, Ph.D. +86-21-65985082 zuow@regend.cn
Contact: Xiaotian Dai, M.D. +86-23-68765681 daixt1973@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02722642
Other Study ID Numbers  ICMJE 201602301
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Xiaotian Dai, Regend Therapeutics
Study Sponsor  ICMJE Regend Therapeutics
Collaborators  ICMJE
  • Southwest Hospital, China
  • Tongji University
Investigators  ICMJE
Study Chair: Wei Zuo, Ph.D. Regend Therapeutics Co.Ltd
PRS Account Regend Therapeutics
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP