REGEND001 Autologous Basal Layer Stem Cell Transplantation for Bronchiectasis: A Translational Application Study
NCT ID: NCT06987214
Last Updated: 2025-05-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1
10 participants
INTERVENTIONAL
2025-06-30
2026-05-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Bronchiectasis patients
REGEND001 Autologous Basal Layer Stem Cell Suspension
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.
Interventions
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REGEND001 Autologous Basal Layer Stem Cell Suspension
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.
Eligibility Criteria
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Inclusion Criteria
2. Confirmed diagnosis of bronchiectasis.
3. FEV1 ≥35% predicted; DLCO ≥30% and \<80% predicted.
Exclusion Criteria
2. Active malignancy or history of malignancy.
3. Positive serology for HIV, HBV, HCV, or syphilis.
25 Years
80 Years
ALL
No
Sponsors
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Ruijin Hospital
OTHER
Responsible Party
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Jieming QU
Professor
Other Identifiers
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20250514
Identifier Type: -
Identifier Source: org_study_id
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