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| Name | Class |
|---|---|
| Regend Therapeutics | INDUSTRY |
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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 randomized, single-blinded, controlled pilot clinical trial at 1/2 phase. During the process, autologous bronchial basal cells (BBCs) will be dissected from trial tissue via 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 airway clearance. The investigators will evaluate the safety and effectiveness of the treatment by measuring a serial of indicators, including occurrence of adverse events, pulmonary function, 6 minute walk distance (6MWD), the distance-saturation product (DSP), St. George's Respiratory Questionnaire (SGRQ), FACED scoring, bronchiectasis severity index (BSI) , and high-resolution computed tomography (HRCT) at week 4, week 12, and week 24 after cell transplantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cell treatment group | Experimental | Patients receive both autologous BBCs transplantation and B-ACT therapy. |
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| Control group | Sham Comparator | Patients only receive B-ACT therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bronchial basal cells (BBCs) | Biological | Airway epithelial cells were collected in patients of the cell treatment group by a disposable 2-mm brush in order to obtain BBCs. The obtained tissue were washed and enzymatically digested to form a single-cell suspension, which was then cultured under R-Clone system, a patented technique of Regend Therapeutics, Ltd.. For patients in the cell treatment group, on the basis of B-ACT therapy, they were also received autologous BBCs transplantation. Cell suspension was diluted with normal saline. Fibrotic bronchoscopy was guided into the lobular or segmental airways and cells were instilled into lobes. |
| Measure | Description | Time Frame |
|---|---|---|
| Diffusing capacity of the lung for carbon monoxide (DLCO) | An indicator of pulmonary function | Week 4, 12, and 24 after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Forced expiratory volume measured at the first second (FEV1) | An indicator for pulmonary function test to assess airway obstruction | Week 4, 12, and 24 after treatment |
| Forced vital capacity (FVC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yun Feng, M.D., Ph.D | Ruijin Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital Shanghai JiaoTong University School of Medicine | Shanghai | Shanghai Municipality | 200025 | 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. | |
| 29344809 | Background | Ma Q, Ma Y, Dai X, Ren T, Fu Y, Liu W, Han Y, Wu Y, Cheng Y, Zhang T, Zuo W. Regeneration of functional alveoli by adult human SOX9+ airway basal cell transplantation. Protein Cell. 2018 Mar;9(3):267-282. doi: 10.1007/s13238-018-0506-y. Epub 2018 Jan 17. |
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| ID | Term |
|---|---|
| D001987 | Bronchiectasis |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
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Eligibility patients were randomly assigned in a 1:1 ratio to receive either autologous cell transplantation therapy (cell treatment group) or bronchoscopic airway clearance treatment (B-ACT therapy, control group).
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The opaque sealed envelope method was used to conceal the allocation sequence. Both patients and investigators, except for the bronchoscopy operators, remained masked to the treatment assignment for the duration of the study. Only the investigators who performed the bronchoscopy were unblinded. The non-blinded investigators should not disclose any blind information to other investigators, participants, care providers, or outcomes assessors.
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| Bronchoscopic airway clearance treatment (B-ACT) | Procedure | The bronchoscopy was performed by board-certified respiratory physicians of Ruijin Hospital using a flexible fiber-optic bronchoscope. B-ACT therapy was performed on all patients in both groups according to the protocol. In brief, continuous suction was performed with the sputum aspirator from the trachea to the subsegmental during the entering of bronchoscope to remove the visible secretions from entire respiratory tract, and then operators used normal saline to collect lavage fluid (the volume various depending on the operator's judgement). |
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An indicator for pulmonary function test to indicate the maximum amount of air a person can expel from the lungs after a maximum inhalation
| Week 4, 12, and 24 after treatment |
| The ratio of forced expiratory volume in the first one second to the forced vital capacity (FEV1/FVC) | 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 | Week 4, 12, and 24 after treatment |
| Maximum Mid Expiratory Flow (MMEF) | 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 | Week 4, 12, and 24 after treatment |
| Maximum Voluntary Ventilation (MVV) | An indicator in pulmonary function test to measure the maximum amount of air that can be inhaled and exhaled within one minute | Week 4, 12, and 24 after treatment |
| 6 minute walk distance (6MWD) and distance saturation product (DSP) | An indicator for heart and pulmonary function | Week 4, 12, and 24 after treatment |
| St. George's Respiratory Questionnaire (SGRQ) | An indicator to measure health status (quality of life) in patients with diseases of airways obstruction | Week 4, 12, and 24 after treatment |
| FACED scoring | 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". | Week 4, 12, and 24 after treatment |
| Bronchiectasis Severity Index (BSI) | A combination of clinical, radiological and microbiological features to predict morbidity and mortality. | Week 4, 12, and 24 after treatment |
| High resolution computed tomography (HR-CT) imaging of lung | An indicator for analysis of dilated bronchi, HR-CT images of lung will be analyzed to indicate the pulmonary structure | Week 4, 12, and 24 after treatment |
| Safety outcomes: adverse events | Any unexpected and unfavorable medical occurrence related to any medical intervention in the study | Through study completion, an average of 24 weeks |
| 39566467 | Derived | Yan J, Zhang W, Feng Y, Liu X, Niu L, Guo Y, Zhou L, Shi M, Di C, Zhang Q, Wang X, Zhou J, Dai R, Ni L, Bao Z, Yan T, Hu Y, Wang P, Zhang T, Zhou M, Zuo W, Qu J. Autologous transplantation of P63+ lung progenitor cells in patients with bronchiectasis: A randomized, single-blind, controlled trial. Cell Rep Med. 2024 Nov 19;5(11):101819. doi: 10.1016/j.xcrm.2024.101819. |