REGEND001 Autologous Basal Layer Stem Cell Transplantation for Interstitial Lung Disease (ILD): A Translational Application Study

Recruiting now · Phase 1

Conditions studied: Interstitial Lung Disease (ILD)

In brief

This clinical trial evaluates the safety and efficacy of REGEND001, an autologous bronchial basal layer stem cell therapy, in patients with interstitial lung disease (ILD). The treatment involves harvesting the patient's own stem cells (expressing KRT5/P63 markers), expanding them ex vivo, and administering them via bronchoscopic infusion to regenerate damaged lung tissue.

Key facts

Study ID

NCT06998706

Run by

Ruijin Hospital

People needed

10

Starts

2025-06-19

Expected to finish

2029-06-30

Last updated by the study team

2026-07-28

Who can join

Age: 40 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 40-75 years.
• Confirmed diagnosis of ILD (e.g., IPF, connective tissue disease-associated ILD).
• 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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