An Exploratory Study on the Treatment of Chronic Obstructive Pulmonary Disease With Autologous Bronchial Basal Cell Transplantation
Condition: Cell Transplantation
Study type: Interventional

Summary: 
      Chronic obstructive pulmonary disease(COPD)is characterized by recurrent cough, expectoration
      and asthma, and eventually develop chronic pulmonary heart disease ,chronic respiratory
      failure and even death. The current clinical treatments for these patients are symptomatic
      treatment cannot solve the problem of the damaged lung structure fundamentally. Recent
      studies show that bronchial basement the layer of cells is a kind of cells in the bronchial
      epithelial basal layer position, the specific expression of Krt5 antigen with the
      regeneration and repair of lung function , these cells have the activity similar to adult
      tissue stem cells. Its division and migration are more active and can continue to produce new
      cells to complement the death of other types of epithelial cells with functional plasticity
      which can be used to direct repair the bronchial and alveolar structures. It has been proved
      that bronchial basal cell transplantation can repair the damaged lungs of experimental
      animals . The bronchial basal cells from autologous tissue, so there is no immune rejection
      problem. Also because the bronchial basal cells derived from adult tissues which is a part of
      the body, so there is no risk of a tumor (in animal experiments, In animal experiments,
      bronchial basal cells transtracheal input 100 times in human dose still no tumor formation).
      In the early stage, patients with COPD (2 cases), bronchiectasis (2 cases) and interstitial
      lung disease (1 case) received the treatment, and the overall effect was good. Diseases were
      alleviated and recovered to some different extend.The study was to brush bronchial basal
      cells through fiberbronchoscopy in COPD patients and cultured in vitro, and then through the
      bronchoscope transfusion to the lesion site. To preliminary evaluate the efficacy and safety
      of autologous bronchial basal cells in the treatment of chronic obstructive pulmonary
      disease.
    

Detailed description: 
      Between November 2016 and November 2019, the investigators initially recruited 20 with stable
      COPD patients. Primary evaluations including medical history, physical examination,
      anthropometric data, blood routine, blood biochemistry, blood coagulation,
      electrocardiogram,high resolution chest CT, arterial blood gas, pulmonary function test,6-min
      walking test(6MWT),modified medical research council(MMRC),St George's respiratory
      questionnaire(SGRQ). After initial evaluation, the investigators obtained extraction
      bronchial basal cells micro tissue from 3~4 grade bronchus to by mean of fiberbronchoscopy,
      then purified and selectively amplified bronchial basal cells to reserve .The basal layer
      cell culture system for our partners (Regend Therapeutics) patented technology using culture
      medium containing special combination of growth factors and composite materials to simulated
      composite basal layer environment and can selectively amplified bronchial basal cells, while
      other types of mature epithelial cells and fibroblasts could not grow naturally. After a
      period of time, the basal lamina of the bronchial epithelial cells can be stored in the
      liquid nitrogen cell bank for a long time. Before applied to the patient, bronchial basal
      cells need to go through a series of strict examination. Then, bronchoscopy was performed
      again and the bronchial basal lamina suspension was injected directly into the lesion site .
      Estimate the change of respiratory function(symptoms, signs, chest CT, pulmonary function,
      the 6 minute walk test, MMRC, SGRQ etc) and serum index in third days , first months, third
      months, sixth months and first years of the follow-up after treatment respectively, to
      evaluate the safety and efficiency of autologous bronchial basal cells for treatment of COPD
      .
    

Intervention name(s): autologous bronchial basal cell transplantation
Intervention type(s): Other
Intervention description(s): the investigators obtained extraction bronchial basal cells micro tissue from 3~4 grade bronchus, then purified and selectively amplified bronchial basal cells to reserve . After a period of time, the basal lamina of the bronchial epithelial cells can be stored in the liquid nitrogen cell bank for a long time. Before applied to the patient, bronchial basal cells need to go through a series of strict examination. Then, bronchoscopy was performed again and the bronchial basal lamina suspension was injected directly into the lesion site .
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment