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

RecruitingPhase 1Ages 40 Years - 75 YearsAllRuijin Hospital
NCT06998706 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • REGEND001 Autologous Basal Layer Stem Cell Suspension
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Where

2 sites
Ruijin Hospital Hainan Branch, Shanghai Jiao Tong University School of Medicine
Qionghai, China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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