Autologous bronchial basal cell transplant to treat COPD

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 early-phase study evaluates safety and potential benefit of REGEND001, a therapy using a patient’s own bronchial basal cells. Cells are collected by bronchial brushing, expanded, and reintroduced into the lungs via bronchoscopy. The primary goal is to see if diffusion capacity (DLCO) improves, with secondary measures including lung ventilation and other lung function parameters. The study includes participants with COPD who meet specific lung function criteria and excludes those with certain infections or prior cancers. Conducted at Ruijin Hospital and affiliated sites in Shanghai and Hainan, the trial spans Phase 1 and Phase 2 to explore feasibility and preliminary efficacy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Diagnosed with COPD according to the 2021 Global Initiative for Chronic Obstructive Lung Disease (GOLD);
2. Post-bronchodilator FEV1/FVC \<70%;
3. DLCO ≥20% and \<80% of predicted value.

Exclusion Criteria:

1. Pregnant, breastfeeding, or planning to become pregnant within 1 year after treatment (or male participants planning for their spouse to become pregnant);
2. Positive for syphilis (TP-Ab), HIV, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies;
3. Current or past history of malignancy.

Where it's running

• Ruijin Hospital Hainan Branch, Shanghai Jiao Tong University School of Medicine
  Qionghai, Hainan, China Recruiting
• Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Jiayang Yan
• Email: yjy19960816@163.com
• Phone: +8619821839207

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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.