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Recruiting NCT06987214

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

Phase I Interventional Bronchiectasis Adult

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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: Bronchiectasis Adult. Basic parameters: 25 years — 80 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 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.

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 FEV1 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]
  • Change in HRCT lung imaging scores [Time frame: Baseline, 4 weeks post treatment, 24 weeks post treatment]
  • Quality of life (QoL) assessment via validated questionnaires [Time frame: Baseline, 4 weeks post treatment, 24 weeks post treatment]

Eligibility criteria

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.

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: NCT06987214 · 20250514

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗