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

NCT06987214 | Not Yet Recruiting Phase 1

• 1 other identifier: 20250514
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Bronchiectasis Adult

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 FEV1 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

• Change in HRCT lung imaging scores

  Baseline, 4 weeks post treatment, 24 weeks post treatment

• Quality of life (QoL) assessment via validated questionnaires

  Baseline, 4 weeks post treatment, 24 weeks post treatment

Study Arms (1)

Bronchiectasis 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.

Bronchiectasis patients

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

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 14, 2025
• First Posted: May 23, 2025
• Study Start: June 30, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share