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
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 25 Years to 80 Years |
| Sex | All |
| Enrollment | 10 (estimated) |
| Sponsor | Ruijin Hospital Academic / other |
| Locations | 2 sites (Qionghai, Hainan and 1 other locations) |
| Status | Recruiting |
| Started | June 18, 2025 |
| Main results expected | May 30, 2029 |
| Study ends | May 30, 2029 |
| Registry record updated | July 28, 2026 |
| Trial ID | NCT06987214 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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.