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NCT Number: NCT06998706

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

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.

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Key information

Conditions

Interstitial Lung Disease (ILD) Lung Diseases Lung Diseases, Interstitial Respiratory Tract Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Ruijin Hospital Hainan Branch, Shanghai Jiao Tong University School of Medicine, Qionghai, Hainan, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change in DLCO from baseline.

    Time frame: Baseline, 4 weeks post treatment, 24 weeks post treatment

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

Secondary outcomes

  1. Change in FVC from baseline

    Time frame: Baseline, 4 weeks post treatment, 24 weeks post treatment

    The forced vital capacity (FVC) is a measurement of the airflow capacity.

  2. Incidence of adverse events and serious adverse events.

    Time frame: Through study completion, an average of 6 months

  3. High-resolution CT (HRCT) imaging scores

    Time frame: Baseline, 4 weeks post treatment, 24 weeks post treatment

  4. Quality of life (QoL) assessment via validated respiratory questionnaires

    Time frame: Baseline, 4 weeks post treatment, 24 weeks post treatment

    Score range: 0 to 100. Higher scores indicate a worse outcome

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
May 31, 2025
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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