Bronchiectasis Adult
Conditions
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.
Interventions
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.
Sponsors
Ruijin Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Outcome results
None listed