Status:
NOT_YET_RECRUITING
Airway Basal Stem Cell Therapy in Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
Ruijin Hospital
Conditions:
Chronic Obstructive Pulmonary Disease (COPD)
Eligibility:
All Genders
40-80 years
Phase:
PHASE1
PHASE2
Brief Summary
This clinical trial aims to evaluate the safety and efficacy of REGEND001, an autologous bronchial basal cell therapy, for the treatment of Chronic Obstructive Pulmonary Disease (COPD). COPD is a chro...
Eligibility Criteria
Inclusion
- Diagnosed with COPD according to the 2021 Global Initiative for Chronic Obstructive Lung Disease (GOLD);
- Post-bronchodilator FEV1/FVC \<70%;
- DLCO ≥20% and \<80% of predicted value.
Exclusion
- Pregnant, breastfeeding, or planning to become pregnant within 1 year after treatment (or male participants planning for their spouse to become pregnant);
- Positive for syphilis (TP-Ab), HIV, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies;
- Current or past history of malignancy.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2029
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06946953
Start Date
May 1 2025
End Date
December 31 2029
Last Update
April 27 2025
Active Locations (1)
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1
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025