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Autologous Transplantation of Bronchial Basal Cells for Treatment of COPD

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ClinicalTrials.gov Identifier: NCT03655795
Recruitment Status : Unknown
Verified November 2018 by Jieming QU, Ruijin Hospital.
Recruitment status was:  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:
Chronic Obstructive Pulmonary Disease (COPD) is a disease characterized by long-term poor airflow, resulting in chronic pulmonary heart disease, chronic respiratory failure or even death. Till now, the damaged pulmonary bronchus structures in COPD patients cannot be repaired by recent clinical methods so far. 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, pulmonary function, the CT imaging, 6 minute walk distance (6MWD), St. George's Respiratory Questionnaire (SGRQ), modified medical research council (mMRC) dyspnea scale and COPD assessment test (CAT).

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

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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: Autologous Transplantation of Bronchial Basal Cells for Treatment of Chronic Obstructive Pulmonary Disease (COPD)
Estimated Study Start Date : November 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : March 2021

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




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


Secondary Outcome Measures :
  1. Forced expiratory volume measured at the first second (FEV1) [ Time Frame: 6 months -1 year ]
    One of the indicators in pulmonary function test, a marker to assess airway obstruction

  2. Forced vital capacity (FVC) [ Time Frame: 6 months -1 year ]
    One of the indicators in pulmonary function test, indicating 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 -1 year ]
    One of the indicators in pulmonary function test, representing 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 -1 year ]
    One of the indicators in pulmonary function test, standing 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 -1 year ]
    One of the indicators in pulmonary function test, measuring the maximum amount of air that can be inhaled and exhaled within one minute

  6. 6-minute-walk test (6MWT) [ Time Frame: 6 months -1 year ]
    An indicator to evaluate the exercise function of patients with moderate or severe pulmonary heart diseases

  7. Imaging of lung structure by high resolution computed tomography (HR-CT) [ Time Frame: 6 months -1 year ]
    Images of lung will be analyzed to indicate the newly-derived pulmonary structure.

  8. Assess life quality affected by the respiratory problem by St. George's respiratory questionnaire (SGRQ) scale [ Time Frame: 6 months -1 year ]
    Total scores (0-100) will be calculated and compared before and after transplantation, and higher values represent a better outcome.

  9. Modified medical research council (mMRC) chronic dyspnea scale to evaluate the level of dyspnea [ Time Frame: 6 months -1 year ]
    mMRC Dyspnea Scale scores (1-5) will be measured and compared before and after transplantation, and lower values represent a better outcome.

  10. COPD Assessment Test (CAT) [ Time Frame: 6 months -1 year ]
    A patient-completed questionnaire assessing all aspects of the impact of COPD



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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects aged between 40 to 75.
  • Subjects diagnosed with COPD and meet the following standards: a.sustained airway obstruction; b.presence of persistent airflow limitation confirmed by post-bronchodilator FEV1<70% predicted value and FEV1/FVC < 0.7.
  • Subjects with pulmonary emphysema confirmed by imaging evidence.
  • Subjects with DLCO<80% predicted value in pulmonary function test.
  • Subjects with stable condition for more than 4 weeks.
  • Subjects tolerant to bronchoscopy.
  • Subjects signed informed consent.

Exclusion Criteria:

  • Pregnant or lactating women.
  • Subjects with syphilis or any of HIV, HBV, HCV positive antibody.
  • Subjects with any malignancy.
  • Subjects suffering from any of the following pulmonary diseases: asthma, active tuberculosis, pulmonary embolism, pneumothorax, pulmonary artery hypertension or interstitial lung disease.
  • 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 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): NCT03655795


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

Sponsors and Collaborators
Ruijin Hospital
Regend Therapeutics
Investigators
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Principal Investigator: Yun Feng, M.D., Ph.D Ruijin Hospital
Publications:
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Responsible Party: Jieming QU, Principal Investigator, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT03655795    
Other Study ID Numbers: 201809
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No