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

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

Recruiting
40-75 years
All
Phase 1
  • Technical (Original)
  • Simplified (AI rewritten)

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Overview

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

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.

Study details
    Interstitial Lung Disease (ILD)

NCT06998706

Ruijin Hospital

25 July 2026

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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