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NCT Number: NCT06987214

REGEND001 Autologous Basal Layer Stem Cell Transplantation for Bronchiectasis: A Translational Application Study

This clinical trial aims to evaluate the safety and efficacy of REGEND001, an autologous basal layer stem cell transplantation therapy, in patients with chronic structural lung disease (bronchiectasis). The treatment involves harvesting bronchial basal layer stem cells from the patient, expanding them ex vivo, and reintroducing them via bronchoscopic infusion to repair damaged lung tissue.

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Key information

Conditions

Bronchiectasis Adult

Age range

25 year–80 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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 25-80 years.
  • Confirmed diagnosis of bronchiectasis.
  • FEV1 ≥35% predicted; 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 FEV1 from baseline

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

    The forced expiratory volume in 1s (FEV1) 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. Change in HRCT lung imaging scores

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

    HRCT, high-resolution computed tomography.

  4. Quality of life (QoL) assessment via validated 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 23, 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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