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

Phase 1

Not yet recruiting

• Conditions: Bronchiectasis Adult
• Interventions: Biological: REGEND001 Autologous Basal Layer Stem Cell Suspension

• Registration Number: NCT06987214
• Lead Sponsor: Ruijin Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-14
• Study First Submitted QC: 2025-05-22
• Last Update Submitted: 2025-05-22
• Study First Posted: 2025-05-23
• Last Update Posted: 2025-05-23
• Study Start: 2025-06-30
• Primary Completion: 2026-05-30
• Study Completion: 2026-05-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Age 25-80 years.
2. Confirmed diagnosis of bronchiectasis.
3. FEV1 ≥35% predicted; DLCO ≥30% and <80% predicted.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bronchiectasis patients	REGEND001 Autologous Basal Layer Stem Cell Suspension	-

Primary Outcome Measures

Name	Time	Method
Change in DLCO from baseline.	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 Outcome Measures

Name	Time	Method
Change in FEV1 from baseline	Baseline, 4 weeks post treatment, 24 weeks post treatment	The forced expiratory volume in 1s (FEV1) is a measurement of the airflow capacity.
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	HRCT, high-resolution computed tomography.
Quality of life (QoL) assessment via validated questionnaires	Baseline, 4 weeks post treatment, 24 weeks post treatment	Score range: 0 to 100. Higher scores indicate a worse outcome.