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

NCT06998706 | Not Yet Recruiting Phase 1

• 1 other identifier: 20250515
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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)

Outcome Measures

Primary Outcomes (1)

• Change in DLCO from baseline.

  The diffusing capacity of the lungs for carbon monoxide (DLCO) is a measurement of the gas transfer capacity of lung.

  Baseline, 4 weeks post treatment, 24 weeks post treatment

Secondary Outcomes (4)

• Change in FVC from baseline

  Baseline, 4 weeks post treatment, 24 weeks post treatment

• Incidence of adverse events and serious adverse events.

  Through study completion, an average of 6 months

• High-resolution CT (HRCT) imaging scores

  Baseline, 4 weeks post treatment, 24 weeks post treatment

• Quality of life (QoL) assessment via validated respiratory questionnaires

  Baseline, 4 weeks post treatment, 24 weeks post treatment

Study Arms (1)

ICD patients

EXPERIMENTAL

Biological: REGEND001 Autologous Basal Layer Stem Cell Suspension

Interventions

REGEND001 Autologous Basal Layer Stem Cell Suspension 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.

ICD patients

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 40-75 years.
• Confirmed diagnosis of ILD (e.g., IPF, connective tissue disease-associated ILD).
• DLCO ≥30% and \<80% predicted.

You may not qualify if:

• Pregnancy, lactation, or plans for pregnancy within 1 year.
• Active malignancy or history of malignancy.
• Positive serology for HIV, HBV, HCV, or syphilis.

Sponsors & Collaborators

• Ruijin Hospital: lead

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: May 31, 2025
• Study Start: June 30, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share