Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 5 of 224 for:    Bronchiectasis

Autologous Transplantation of Bronchial Basal Cells 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03655808
Recruitment Status : Not yet recruiting
First Posted : August 31, 2018
Last Update Posted : November 6, 2018
Sponsor:
Collaborator:
Regend Therapeutics
Information provided by (Responsible Party):
Jieming QU, Ruijin Hospital

Brief Summary:
Bronchiectasis is a disease resulted from progressive destruction of bronchi with no effective drug for its treatment. In this study, we intends to carry out a single-centered, non-randomized and self-controlled clinical trial at an early phase. During the process, autologous bronchial basal cells (BBCs) will be dissected from trial tissue from bronchoscopic brushing. Then the BBCs will be expanded and detected by quality control. In the following, qualified BBCs 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 a serial of indicators, including occurrence of adverse events, the CT imaging of dilated bronchi, pulmonary function, 6 minute walk distance (6MWD), the distance-saturation product (DSP), St. George's Respiratory Questionnaire (SGRQ), FACED scoring and bronchiectasis severity index (BSI) evaluation.

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: self-control
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Autologous Transplantation of Bronchial Basal Cells for Treatment of Bronchiectasis
Estimated Study Start Date : November 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : March 2021

Arm Intervention/treatment
Experimental: BBCs transplantation
Autologous Bronchial basal cells transplantation
Biological: Bronchial basal cells
Bronchial basal cells transplantation




Primary Outcome Measures :
  1. Diffusing capacity of the lung for carbon monoxide (DLCO) [ Time Frame: 6 months ]
    An indicator of pulmonary function


Secondary Outcome Measures :
  1. Forced expiratory volume measured at the first second (FEV1) [ Time Frame: 6 months ]
    An indicator for pulmonary function test to assess airway obstruction

  2. Forced vital capacity (FVC) [ Time Frame: 6 months ]
    An indicator for pulmonary function test to indicate the maximum amount of air a person can expel from the lungs after a maximum inhalation

  3. The ratio of forced expiratory volume in the first one second to the forced vital capacity (FEV1/FVC) [ Time Frame: 6 months ]
    An indicator in pulmonary function test to represent the proportion of a person's vital capacity that they are able to expire in the first second of forced expiration to the full vital capacity

  4. Maximum Mid Expiratory Flow (MMF) [ Time Frame: 6 months ]
    An indicator in pulmonary function test to stand for maximal (mid-)expiratory flow and is the peak of expiratory flow as taken from the flow-volume curve and measured in liters per second

  5. Maximum Voluntary Ventilation (MVV) [ Time Frame: 6 months ]
    An indicator in pulmonary function test to measure the maximum amount of air that can be inhaled and exhaled within one minute

  6. 6 minute walk distance (6MWD) and distance saturation product (DSP) [ Time Frame: 6 months ]
    An indicator for heart and pulmonary function

  7. High resolution computed tomography (HR-CT) imaging of lung [ Time Frame: 6 months ]
    An indicator for analysis of dilated bronchi, HR-CT images of lung will be analyzed to indicate the pulmonary structure

  8. St. George's Respiratory Questionnaire (SGRQ) [ Time Frame: 6 months ]
    An indicator to measure health status (quality of life) in patients with diseases of airways obstruction

  9. FACED scoring [ Time Frame: 6 months ]
    An assessment of severity tool, validated for people with non-cystic fibrosis bronchiectasis. F means "FEV1", A means "Age", C means "Chronic colonization", E means "Extension", D means "Dyspnoea".

  10. Bronchiectasis Severity Index (BSI) [ Time Frame: 6 months ]
    A combination of clinical, radiological and microbiological features to predict morbidity and mortality.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 a DLCO < 80% predicted value.
  • 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 any of HIV, HBV, HCV positive antibody.
  • Subjects with any malignancy.
  • Subjects with 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 with 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 of the upper limit of normal.
  • Subjects with liver disease or liver damage: ALT, AST, total bilirubin> 2 times of 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.

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): NCT03655808


Contacts
Layout table for location contacts
Contact: Jieming Qu, M.D., Ph.D +86-021-64370045 jmqu0906@163.com
Contact: Wei Zuo, Ph. D +86-21-65985082 zuow@regend.cn

Sponsors and Collaborators
Ruijin Hospital
Regend Therapeutics
Investigators
Layout table for investigator information
Principal Investigator: Yun Feng, M.D., Ph.D Ruijin Hospital

Publications:
Layout table for additonal information
Responsible Party: Jieming QU, Principal Investigator, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT03655808     History of Changes
Other Study ID Numbers: 201810
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jieming QU, Ruijin Hospital:
Bronchiectasis
Bronchial basal cells
Autologous transplantation

Additional relevant MeSH terms:
Layout table for MeSH terms
Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases