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Status unknownNCT02722642Updated Mar 18, 2020

Autologous Bronchial Basal Cells Transplantation for Treatment of Bronchiectasis

A Phase 1/2 interventional study of Bronchial basal cells in Bronchiectasis, sponsored by Regend Therapeutics. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-03-18.

Sponsored by Regend Therapeutics · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Bronchiectasis

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03

In context

Bronchiectasis

373 studies on the registry are indexed under Bronchiectasis; 104 are open to participants now.

This study's planned enrollment of 20 is below the median of 59 across 238 interventional studies indexed under Bronchiectasis.

Browse Bronchiectasis studies →

Lead sponsor

Regend Therapeutics is the lead sponsor of 11 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subjects diagnosed as bronchiectasis.
  • Subjects with at least 6 lung segments affected.
  • Subjects with stable condition for more than 2 weeks.
  • Subjects can tolerate bronchoscopy.
  • Subjects signed informed consent.

Exclusion criteria

Exclusion Criteria:

  • Women of childbearing age at the stage of pregnancy or lactation, or those without taking effective contraceptive measures.
  • Subjects with syphilis or HIV positive antibody.
  • Subjects with any malignancy.
  • Subjects suffering from any of the following pulmonary diseases: active tuberculosis, pulmonary embolism, pneumothorax, multiple huge bullae, uncontrolled asthma, acute exacerbation of chronic bronchitis or extremely severe COPD.
  • 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 the upper limit of normal.
  • Subjects with liver disease or liver damage: ALT, AST, total bilirubin> 2 times 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.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Bronchial basal cells

    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.

    Biological: Bronchial basal cells

Interventions

  • BiologicalBronchial basal cells

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 day - 6 months

Secondary outcomes

  1. 6-minute walk distance test

    Time frame: 3 day - 6 months

  2. MRC chronic dyspnea scale

    Time frame: 3 day - 6 months

  3. St. George's Respiratory Questionnaire (SGRQ) scale

    Time frame: 3 day - 6 months

  4. inflammation indicators

    TNF-α,IL1-β,PDGF,MMP9,TIMP1,CRP, PCT

    Time frame: 3 day - 6 months

  5. fibrotic factor level

    TGF-β, Hydroxyproline

    Time frame: 3 day - 6 months

  6. incidence of acute exacerbation

    Time frame: 3 day-6 months

  7. patients' self-evaluation

    The self-efficacy evaluation can also be classified into four levels: effective, improved, stable and invalid.

    Time frame: 3 day - 6 months

  8. blood gas level（PH）

    Time frame: 3 day - 6 months

  9. blood gas level（HCO3）

    Time frame: 3 day - 6 months

  10. blood gas level（PaCO2）

    Time frame: 3 day - 6 months

  11. blood gas level（PaO2）

    Time frame: 3 day - 6 months

  12. pulmonary function test (DLco)

    Diffusing capacity of CO

    Time frame: 3 day - 6 months

  13. pulmonary function test (FEV1)

    Forced expiratory volume in one second, FEV1

    Time frame: 3 day - 6 months

  14. pulmonary function test (FVC)

    forced vital capacity

    Time frame: 3 day - 6 months

  15. pulmonary function test (MVV)

    maximal voluntary ventilation

    Time frame: 3 day - 6 months

  16. pulmonary function test (MMEF)

    maximal midexpiratory flow curve

    Time frame: 3 day - 6 months

07

Study locations

1 of 1 sites recruiting
  • First Affiliated Hospital of the Third Military University, PLA (Southwest Hospital)
    Chongqing, Chongqing Municipality 400038, China
    • Xiaotian Dai, M.D. · Contact · daixt1973@163.com · 86-23-68765681
    • Wei Zuo, Ph.D. · Contact · zuow@regend.cn · 86-10-65985082
    • Ting Zhang, Ph.D. · Sub investigator
    • Yu Ma, Ph.D. · Sub investigator
    Recruiting
08

References and documents

Publications

  • 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. PubMed 25383540 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02722642
Lead sponsor
Regend Therapeutics
Collaborators
Southwest Hospital, China, Tongji University
Responsible party
Xiaotian Dai (Principal Investigator, Regend Therapeutics) — Principal investigator
First posted
Mar 30, 2016
Start date
Mar 2016
Primary completion
Jun 2020 (estimated)
Completion
Jun 2020 (estimated)
Last update
Mar 18, 2020

Study contacts

Wei Zuo, Ph.D.
Contact
zuow@regend.cn
+86-21-65985082
Xiaotian Dai, M.D.
Contact
daixt1973@163.com
+86-23-68765681
Wei Zuo, Ph.D.
study chair · Regend Therapeutics Co.Ltd

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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