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

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age25-80
SponsorRuijin Hospital

About this trial

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.

Eligibility criteria

Qualifiers

Age 25-80 years.

Confirmed diagnosis of bronchiectasis.

FEV1 ≥35% predicted; DLCO ≥30% and <80% predicted.

Disqualifiers

Pregnancy, lactation, or plans for pregnancy within 1 year.

Active malignancy or history of malignancy.

Positive serology for HIV, HBV, HCV, or syphilis.

Trial design

Treatments tested in this trial

  • REGEND001 Autologous Basal Layer Stem Cell Suspension

Treatment groups

10 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators