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Recruiting NCT06998706

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

Phase I Interventional Interstitial Lung Disease (ILD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: REGEND001 Autologous Basal Layer Stem Cell Suspension.
Who it may be relevant to
Registry conditions: Interstitial Lung Disease (ILD). Basic parameters: 40 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

Interventions

  • Biological 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.

Primary outcome measures

  • Change in DLCO from baseline. [Time frame: Baseline, 4 weeks post treatment, 24 weeks post treatment]
Secondary outcome measures (4)
  • Change in FVC from baseline [Time frame: Baseline, 4 weeks post treatment, 24 weeks post treatment]
  • Incidence of adverse events and serious adverse events. [Time frame: Through study completion, an average of 6 months]
  • High-resolution CT (HRCT) imaging scores [Time frame: Baseline, 4 weeks post treatment, 24 weeks post treatment]
  • Quality of life (QoL) assessment via validated respiratory questionnaires [Time frame: Baseline, 4 weeks post treatment, 24 weeks post treatment]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 2 centers
  • Ruijin Hospital Hainan Branch, Shanghai Jiao Tong University School of Medicine — Qionghai
  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai

Identifiers

NCT: NCT06998706 · 20250515

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗