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

NCT ID: NCT06998706

Last Updated: 2025-05-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2026-06-30

Brief Summary

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.

Conditions

Interstitial Lung Disease (ILD)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ICD patients

Group Type: EXPERIMENTAL

REGEND001 Autologous Basal Layer Stem Cell Suspension

Intervention Type: BIOLOGICAL

REGEND001 Autologous Basal Layer Stem Cell Suspension is an innovative cell therapy product designed for chronic structural lung diseases, such as bronchiectasis. This treatment involves harvesting regenerative stem cells (expressing KRT5/P63 markers) from the patient's own bronchial basal layer via fiberoptic bronchoscopy. After isolation, purification, and ex vivo expansion, the cells are administered as a suspension through bronchoscopic infusion into damaged lung segments.

Interventions

REGEND001 Autologous Basal Layer Stem Cell Suspension

REGEND001 Autologous Basal Layer Stem Cell Suspension is an innovative cell therapy product designed for chronic structural lung diseases, such as bronchiectasis. This treatment involves harvesting regenerative stem cells (expressing KRT5/P63 markers) from the patient's own bronchial basal layer via fiberoptic bronchoscopy. After isolation, purification, and ex vivo expansion, the cells are administered as a suspension through bronchoscopic infusion into damaged lung segments.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jieming QU

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

20250515

Identifier Type: -

Identifier Source: org_study_id