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

Shanghai Jiao Tong University

Status and phase: Not yet enrolling; Phase 1

Conditions: Bronchiectasis Adult

Treatments: Biological: REGEND001 Autologous Basal Layer Stem Cell Suspension

Study type: Interventional

Funder types: Other

Identifiers

NCT06987214

20250514

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 25 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Bronchiectasis patients

Experimental group

Treatment:

Biological: REGEND001 Autologous Basal Layer Stem Cell Suspension