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

Recruiting now · Phase 1

Conditions studied: Bronchiectasis Adult

In brief

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.

Key facts

Study ID

NCT06987214

Run by

Ruijin Hospital

People needed

10

Starts

2025-06-18

Expected to finish

2029-05-30

Last updated by the study team

2026-07-28

Who can join

Age: 25 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• Ruijin Hospital Hainan Branch, Shanghai Jiao Tong University School of Medicine — Qionghai, Hainan, China (enrolling)
• Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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