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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age40-75
SponsorRuijin Hospital

About this trial

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 criteria

Qualifiers

Age 40-75 years.

Confirmed diagnosis of ILD (e.g., IPF, connective tissue disease-associated ILD).

DLCO ≥30% and <80% predicted.

Disqualifiers

Pregnancy, lactation, or plans for pregnancy within 1 year.

Active malignancy or history of malignancy.

Positive serology for HIV, HBV, HCV, or syphilis.

Trial design

Treatments tested in this trial

  • REGEND001 Autologous Basal Layer Stem Cell Suspension

Treatment groups

10 Participants
are divided into 1 treatment group

Sponsors and collaborators