Autologous Basal Layer Stem Cells for Interstitial Lung Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This first-in-human translational study uses autologous basal layer stem cells (expressing KRT5/P63) harvested from patients, expanded outside the body, and delivered to the lungs via bronchoscopic infusion. The aim is to assess safety and potential efficacy in regenerating damaged lung tissue in ILD. Eligible adults are 40–75 with confirmed ILD and specific lung function criteria, excluding those with active cancer or certain infections. Multiple sites in Shanghai and Hainan will enroll participants under a lead sponsorship from Ruijin Hospital. The approach represents a procedures-based cell therapy with careful patient selection and close monitoring for adverse events and early signals of benefit.

Why it matters

Who can join: the full rules

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.

Where it's running

• Ruijin Hospital Hainan Branch, Shanghai Jiao Tong University School of Medicine
  Qionghai, Hainan, China Recruiting
• Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
  Shanghai, Shanghai Municipality, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.