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Autologous Bronchial Basal Cells Transplantation for Treatment of Bronchiectasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02722642
Recruitment Status : Unknown
Verified March 2020 by Xiaotian Dai, Regend Therapeutics.
Recruitment status was:  Recruiting
First Posted : March 30, 2016
Last Update Posted : March 18, 2020
Sponsor:
Collaborators:
Southwest Hospital, China
Tongji University
Information provided by (Responsible Party):
Xiaotian Dai, Regend Therapeutics

Study Description
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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.

Condition or disease Intervention/treatment Phase
Bronchiectasis Biological: Bronchial basal cells Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-center, Non-randomized, Before-and-after Self Control Study of Bronchial Basal Cell Transplantation for Bronchiectasis Treatment
Study Start Date : March 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020
Arms and Interventions
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Arm Intervention/treatment
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 6-minute walk distance test [ Time Frame: 3 day - 6 months ]
  2. MRC chronic dyspnea scale [ Time Frame: 3 day - 6 months ]
  3. St. George's Respiratory Questionnaire (SGRQ) scale [ Time Frame: 3 day - 6 months ]
  4. inflammation indicators [ Time Frame: 3 day - 6 months ]
    TNF-α,IL1-β,PDGF,MMP9,TIMP1,CRP, PCT

  5. fibrotic factor level [ Time Frame: 3 day - 6 months ]
    TGF-β, Hydroxyproline

  6. incidence of acute exacerbation [ Time Frame: 3 day-6 months ]
  7. 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.

  8. blood gas level（PH） [ Time Frame: 3 day - 6 months ]
  9. blood gas level（HCO3） [ Time Frame: 3 day - 6 months ]
  10. blood gas level（PaCO2） [ Time Frame: 3 day - 6 months ]
  11. blood gas level（PaO2） [ Time Frame: 3 day - 6 months ]
  12. pulmonary function test (DLco) [ Time Frame: 3 day - 6 months ]
    Diffusing capacity of CO

  13. pulmonary function test (FEV1) [ Time Frame: 3 day - 6 months ]
    Forced expiratory volume in one second, FEV1

  14. pulmonary function test (FVC) [ Time Frame: 3 day - 6 months ]
    forced vital capacity

  15. pulmonary function test (MVV) [ Time Frame: 3 day - 6 months ]
    maximal voluntary ventilation

  16. pulmonary function test (MMEF) [ Time Frame: 3 day - 6 months ]
    maximal midexpiratory flow curve


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02722642


Contacts
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Contact: Wei Zuo, Ph.D. +86-21-65985082 zuow@regend.cn
Contact: Xiaotian Dai, M.D. +86-23-68765681 daixt1973@163.com

Locations
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China, Chongqing
First Affiliated Hospital of the Third Military University, PLA (Southwest Hospital) Recruiting
Chongqing, Chongqing, China, 400038
Contact: Xiaotian Dai, M.D.    86-23-68765681    daixt1973@163.com   
Contact: Wei Zuo, Ph.D.    86-10-65985082    zuow@regend.cn   
Sub-Investigator: Ting Zhang, Ph.D.         
Sub-Investigator: Yu Ma, Ph.D.         
Sponsors and Collaborators
Regend Therapeutics
Southwest Hospital, China
Tongji University
Investigators
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Study Chair: Wei Zuo, Ph.D. Regend Therapeutics Co.Ltd
More Information
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Publications:

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Responsible Party: Xiaotian Dai, Principal Investigator, Regend Therapeutics
ClinicalTrials.gov Identifier: NCT02722642    
Other Study ID Numbers: 201602301
First Posted: March 30, 2016    Key Record Dates
Last Update Posted: March 18, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases