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Clinical Trials in China / NCT06998706
Recruiting Phase 1

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
No
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)

FacilityCityRegionStatus
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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Other trials for the same condition

A Randomized, Double-Blind, Placebo-Controlled Trial of Fufei Huazhuo Tongluo Formula Combined With Standardized Medicine in Patients With Anti-Synthetase Syndrome-Associated Interstitial Lung Disease Starting soon
A Study to Test Tetrandrine Tablets for Connective Tissue Disease-Related Lung Disease Recruiting
Fibrotic Interstitial Lung Disease Early Recognition and Strategic Therapy Study in China Recruiting
A Study of the Pharmacokinetics and Safety of Single-dose Inhaled RJ026 in Healthy Volunteers and Patients With Interstitial Lung Disease Recruiting
Cross-Regional Unmanned Aircraft Transport of Donor Lungs Starting soon
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