Clinical trial Recruiting at 2 sites Phase 1 Interventional Ages 25 to 80

Autologous Basal Layer Stem Cells to Treat Bronchiectasis

Official title: REGEND001 Autologous Basal Layer Stem Cell Transplantation for Bronchiectasis: A Translational Application Study

Run by Ruijin Hospital · NCT06987214 · Data updated 2026-11-12

Researchers will test autologous basal layer stem cells delivered through the airways to see if they can safely improve lung tissue in adults with bronchiectasis.

Quick facts

PhasePhase 1
Study typeInterventional
Ages25 Years to 80 Years
SexAll
Enrollment10 (estimated)
SponsorRuijin Hospital
Academic / other
Locations2 sites (Qionghai, Hainan and 1 other locations)
StatusRecruiting
StartedJune 18, 2025
Main results expectedMay 30, 2029
Study endsMay 30, 2029
Registry record updatedJuly 28, 2026
Trial IDNCT06987214 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 25–80 with confirmed bronchiectasis and FEV1 ≥35% predicted and DLCO ≥30% but <80% predicted.

Probably not a fit

Patients with advanced or rapidly progressing lung disease, or those with certain infections or malignancies, may not benefit from this therapy.

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 interventional study will harvest a patient’s own bronchial basal layer stem cells, expand them outside the body, and reintroduce them via bronchoscopic infusion. The aim is to assess safety and preliminary effectiveness in adults with chronic structural lung disease due to bronchiectasis. Eligible participants are 25 to 80 years old with confirmed bronchiectasis and specific lung function thresholds. Exclusion criteria include pregnancy, active cancer, and certain infectious diseases. The trial is led by Ruijin Hospital with multiple collaborating sites in Shanghai and Hainan, China.

Why it matters

Potential benefit: If successful, participants may experience stabilization or improvement in lung tissue integrity and function related to bronchiectasis.

How similar studies have gone: Early-stage studies of autologous stem cell therapies for lung conditions have shown mixed but promising safety signals; this approach is exploratory in bronchiectasis.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Age 25-80 years.
2. Confirmed diagnosis of bronchiectasis.
3. FEV1 ≥35% predicted; DLCO ≥30% and \<80% predicted.

Exclusion Criteria:

1. Pregnancy, lactation, or plans for pregnancy within 1 year.
2. Active malignancy or history of malignancy.
3. Positive serology for HIV, HBV, HCV, or syphilis.

Where it's running

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

Similar studies

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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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.