Airway basal stem cell treatment for children with bronchiolitis obliterans

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, single-arm Early Phase 1 study testing airway basal stem cell therapy in pediatric bronchiolitis obliterans. The trial is co-sponsored by Regend Therapeutics and Shanghai Children's Hospital and enrolls children able to tolerate bronchoscopy. Participants receive airway basal stem cell intervention and are followed for safety and preliminary signals of benefit including lung function (e.g., FEV1) and dependence on oxygen or mechanical ventilation. The goal is to gather early safety data and initial efficacy evidence to inform future larger studies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Males and females, aged between 28 days and 18 years;
* Diagnosed with bronchiolitis obliterans according to the guidelines;
* Meeting at least one of the following: FEV1 \< 55% of predicted value; requiring continuous assisted mechanical ventilation or oxygen therapy;
* None of acute infections within the past four weeks;
* Tolerating bronchoscopy;
* The child and/or parent(s) provide informed consent, and are able to understand and adhere to scheduled visits, treatments, laboratory tests, and other study procedures.

Exclusion Criteria:

* Subjects with bronchiolitis obliterans syndrome (BOS) who are on a current cGVHD treatment regimen at screening.
* At the time of screening, subject who is positive in each of treponema pallidum antibody (TP-Ab), human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody test. Hepatitis B virus carriers with stable current condition can be enrolled. Cured hepatitis C patients with negative result in HCV ribonucleic acid (RNA) test can be enrolled as well.
* Subject who is assessed to have major lung diseases other than BO by investigators at screening or who has other severe systemic diseases within 6 months prior to screening and is considered to be unsuitable for this study by investigators.
* Presence of severe coagulation dysfunction at screening and may compromise the safety of bronchoscopy in the investigator's judgment.
* Subjects requiring long-term maintenance anticoagulant therapy or antiplatelet aggregation therapy, and for whom, in the investigator's assessment, the medication cannot be discontinued within a week prior to cell collection and infusion.
* Subjects with suicide risk or a history of psychiatric disorders at screening.
* Participation in another interventional clinical study within 3 months prior to screening.
* Poor compliance, making him or her difficult to complete the study.
* Subjects who is considered to be unsuitable for this study in in the opinion of the investigator.

Where it's running

• Shanghai Children's Hospital, School of Medicine, Shanghai Jiao Tong University
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Liling Qian, Professor and Chief Physician
• Email: qianliling@shchildren.com.cn
• Phone: 086-021-62474880

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Examining the airway epithelium in children with post-infectious bronchiolitis obliterans

  This study is trying to see if there are differences in the nose lining of young children who get sick from certain viruses and later develop post-infectious bronchiolitis obliterans compared to those who don’t.

  Recruiting Institut National de la Santé Et de la Recherche Médicale, France · Marseille · NCT06140901

• Using belumosudil to prevent or treat bronchiolitis obliterans in stem cell transplant patients

  This study is testing if a new medication called belumosudil can help prevent or treat bronchiolitis obliterans in patients who have recently had a stem cell transplant.

  Recruiting at 4 sites Phase 2 Dana-Farber Cancer Institute · Stanford, California and 5 other locations · NCT05922761

• Investigating abnormal cells in patients with bronchiolitis obliterans syndrome

  This study is testing whether looking at certain abnormal cells in the blood and lungs of patients with bronchiolitis obliterans syndrome after a transplant can help doctors find this condition earlier.

  Recruiting M.D. Anderson Cancer Center · Houston, Texas · NCT04604522

• Long-term observation of lung injury in children after stem cell transplants

  This study looks at children who have had stem cell transplants to see how often they develop lung problems and how these issues affect their health over time.

  Recruiting at 9 sites Children's Hospital Medical Center, Cincinnati · San Francisco, California and 8 other locations · NCT04098445

• Inhaled LAM-001 for lung transplant patients with bronchiolitis obliterans syndrome

  This study is testing if an inhaled medication called LAM-001 can help lung transplant patients with bronchiolitis obliterans syndrome feel better and improve their lung function.

  Recruiting Phase 2 University of California, San Francisco · San Francisco, California · NCT06018766

• Evaluating ARINA-1 for preventing lung transplant complications

  This study is testing if a new treatment called ARINA-1 can help prevent lung transplant complications in people who have received a bilateral lung transplant.

  Recruiting at 18 sites Phase 3 Renovion, Inc. · Phoenix, Arizona and 21 other locations · NCT05654922

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.