Not Yet RecruitingPhase 1

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

10 participantsStarted 2025-06-30

Plain-language summary

This clinical trial aims to evaluate the safety and efficacy of REGEND001, an autologous basal layer stem cell transplantation therapy, in patients with chronic structural lung disease (bronchiectasis). The treatment involves harvesting bronchial basal layer stem cells from the patient, expanding them ex vivo, and reintroducing them via bronchoscopic infusion to repair damaged lung tissue.

Who can participate

Age range25 Years – 80 Years

SexALL

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Inclusion criteria

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

Exclusion criteria

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

What they're measuring

Change in DLCO from baseline.

Timeframe: Baseline, 4 weeks post treatment, 24 weeks post treatment

Trial details

NCT IDNCT06987214

SponsorRuijin Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-30

View on ClinicalTrials.gov More Bronchiectasis Adult trials