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Treatment of COPD by Autologous Transplantation of Bronchial Basal Cells

NCT03156673 — Early Phase 1, Unknown, 20 participants, First Affiliated Hospital of Shantou University Medical College
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Primary Research on Treatment of Chronic Obstructive Pulmonary Disease (COPD) by Transplantation of Autologous Bronchial Basal Cells

RegistryNCT03156673
StatusUnknown
PhaseEarly Phase 1
Study typeInterventional; na, single group, masking: none, treatment
Enrollment20 (Estimated)
SponsorFirst Affiliated Hospital of Shantou University Medical College (Other); collaborators: Regend Therapeutics, Tongji University
ConditionsChronic Obstructive Pulmonary Disease
Interventionsbronchial basal cells (Biological)
Datesstart 2017-04-01, primary completion 2021-12-31 (estimated), completion 2022-06-30 (estimated), first posted 2017-05-17, last updated 2017-05-17
Locations1 site in China

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-Summary

Bronchial basal cells are proved to be able to regenerate lung structures to repair the injured lung. In COPD patients, bronchus structures are injured and cannot be repaired, which may result in the failure of pulmonary function rescue clinically.In our research, autologous bronchial basal cells will be transplanted into lung of patients suffered with COPD to treat the disease. Specifically, autologous bronchial basal cells will be dissected from brushed-off samples by bronchofiberscope. Then, they will be expanded in vitro and transplanted into lung to regenerate new alveoli and bronchus structures and re-establish pulmonary system.

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+Arms and interventions

ArmTypeInterventionsDescription
bronchial basal cellsExperimentalBiological: bronchial basal cellsPatients will receive of clinical grade bronchial basal cells (BBCs) with a dosage of 10\^6 (1 million) cells/Kg/person via fiberoptic bronchoscopy after fully lavage of the localized lesions.
  • bronchial basal cells (Biological): Patients will receive of clinical grade bronchial basal cells (BBCs) with a dosage of 10\^6 (1 million) cells/Kg/person via fiberoptic bronchoscopy after fully lavage of the localized lesions.

+Outcome measures

Primary outcomes

  • Forced expiratory volume in one second (FEV1) [1-6 months]: An indicator for pulmonary function test to assess airway obstruction
  • Forced vital capacity (FVC) [1-6 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

Secondary outcomes

  • Diffusion capacity of CO (DLCO) [1-6 months]: An indicator for pulmonary function test to show the extent to which oxygen passes from the air sacs of the lungs into the blood
  • The ratio of forced expiratory volume in the first one second to the forced vital capacity (FEV1/FVC) [1-6 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
  • Maximum mid-expiratory flow (MMF) [1-6 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
  • Maximum voluntary ventilation (MVV) [1-6 months]: An indicator in pulmonary function test to measure the maximum amount of air that can be inhaled and exhaled within one minute
  • 6-minute-walk test (6MWT) [1-6 months]: An indicator to evaluate the exercise function of patients with moderate or severe pulmonary heart diseases
  • Modified medical research council (MMRC) chronic dyspnea scale [1-6 months]: An indicator to evaluate the level of dyspnea
  • St. George's respiratory questionnaire (SGRQ) scale [1-6 months]: A questionnaire to assess life quality affected by the respiratory problems

+Eligibility

Sex: All, ages: 40 Years to 75 Years

Inclusion Criteria:

* Aged between 40 to 75;
* Diagnosed with COPD according the guideline (a. with symptoms of productive cough, sputum production or shortness of breath; b. with poor airflow as indicated by FEV1<70% predicted value and FEV1/FVC < 0.7 in pulmonary function test; c. with exclusion of other pulmonary disease by CT or blood examination);
* Clinically stable for more than 4 weeks;
* Tolerant to bronchofiberscope;
* Written informed consent signed.

Exclusion Criteria:

* Pregnant or lactating women;
* Patients positive for syphilis, HIV;
* Patients with malignant tumor;
* Patients with serious or significant pulmonary infection and need anti-infection treatment;
* Patients with serious heart disease(NYHA class Ⅲ-Ⅳ);
* Patients with a history of abusing alcohol and illicit drug;
* Patients participated in other clinical trials in the past 3 months;
* Patients assessed as inappropriate to participate in this clinical trial by investigator.

+Locations (1)

FacilityCityCountryStatus
the First Affiliated Hospital of Shantou University Medical CollegeShantou, GuangdongChinaRecruiting

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