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| Name | Class |
|---|---|
| Southwest Hospital, China | OTHER |
| Tongji University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bronchial basal cells | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bronchial basal cells | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| CT imaging of dilated bronchi | CT image of dilated bronchi will be analyzed.Clinical indicators include the spread of dilation, extent of dilation and the thickness of bronchi wall. | 3 day - 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 6-minute walk distance test | 3 day - 6 months | |
| MRC chronic dyspnea scale | 3 day - 6 months | |
| St. George's Respiratory Questionnaire (SGRQ) scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Zuo, Ph.D. | Contact | +86-21-65985082 | zuow@regend.cn | |
| Xiaotian Dai, M.D. | Contact | +86-23-68765681 | daixt1973@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Wei Zuo, Ph.D. | Regend Therapeutics Co.Ltd | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of the Third Military University, PLA (Southwest Hospital) | Recruiting | Chongqing | Chongqing Municipality | 400038 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25383540 | Background | Zuo W, Zhang T, Wu DZ, Guan SP, Liew AA, Yamamoto Y, Wang X, Lim SJ, Vincent M, Lessard M, Crum CP, Xian W, McKeon F. p63(+)Krt5(+) distal airway stem cells are essential for lung regeneration. Nature. 2015 Jan 29;517(7536):616-20. doi: 10.1038/nature13903. Epub 2014 Nov 12. |
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| ID | Term |
|---|---|
| D001987 | Bronchiectasis |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
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| 3 day - 6 months |
| inflammation indicators | TNF-α,IL1-β,PDGF,MMP9,TIMP1,CRP, PCT | 3 day - 6 months |
| fibrotic factor level | TGF-β, Hydroxyproline | 3 day - 6 months |
| incidence of acute exacerbation | 3 day-6 months |
| patients' self-evaluation | The self-efficacy evaluation can also be classified into four levels: effective, improved, stable and invalid. | 3 day - 6 months |
| blood gas level(PH) | 3 day - 6 months |
| blood gas level(HCO3) | 3 day - 6 months |
| blood gas level(PaCO2) | 3 day - 6 months |
| blood gas level(PaO2) | 3 day - 6 months |
| pulmonary function test (DLco) | Diffusing capacity of CO | 3 day - 6 months |
| pulmonary function test (FEV1) | Forced expiratory volume in one second, FEV1 | 3 day - 6 months |
| pulmonary function test (FVC) | forced vital capacity | 3 day - 6 months |
| pulmonary function test (MVV) | maximal voluntary ventilation | 3 day - 6 months |
| pulmonary function test (MMEF) | maximal midexpiratory flow curve | 3 day - 6 months |