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

NCT06998706 · tracked via the Priya Life Science China tracker

Sponsor

Ruijin Hospital

Phase

Phase 1

Started

2025-06-19

Last updated

2026-07-28

Condition(s) studied

Interstitial Lung Disease (ILD)

Investigational drug(s) / intervention(s)

REGEND001 Autologous Basal Layer Stem Cell Suspension

REGEND001 Autologous Basal Layer Stem Cell Suspension: REGEND001 Autologous Basal Layer Stem Cell Suspension is an innovative cell therapy product designed for chronic structural lung diseases, such as bronchiectasis. This treatment involves harvesting regenerative stem cells (expressing KRT5/P63 markers) from the patient's own bronchial basal layer via fiberoptic bronchoscopy. After isolation, purification, and ex vivo expansion, the cells are administered as a suspension through bronchoscopic infusion into damaged lung segments.

Study summary

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.

Eligibility

Sex

ALL

Min age

40 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: 1. Age 40-75 years. 2. Confirmed diagnosis of ILD (e.g., IPF, connective tissue disease-associated ILD). 3. 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.

Primary outcome measure(s)

Change in DLCO from baseline. — Baseline, 4 weeks post treatment, 24 weeks post treatment
The diffusing capacity of the lungs for carbon monoxide (DLCO) is a measurement of the gas transfer capacity of lung.

Trial sites (2)

Facility	City	Region	Status
Ruijin Hospital Hainan Branch, Shanghai Jiao Tong University School of Medicine	Qionghai	Hainan	Recruiting
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai Municipality	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06998706 on ClinicalTrials.gov ↗ ← All trials in China