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

Shanghai Jiao Tong University

Status and phase: Not yet enrolling; Phase 1

Conditions: Interstitial Lung Disease (ILD)

Treatments: Biological: REGEND001 Autologous Basal Layer Stem Cell Suspension

Study type: Interventional

Funder types: Other

Identifiers

NCT06998706

20250515

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

10 participants in 1 patient group

ICD patients

Experimental group

Treatment:

Biological: REGEND001 Autologous Basal Layer Stem Cell Suspension