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

RecruitingPhase 1Ages 25 Years - 80 YearsAllRuijin Hospital
NCT06987214 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age 25-80 years. 2. Confirmed diagnosis of bronchiectasis. 3. FEV1 ≥35% predicted; 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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