Status:
COMPLETED
A Clinical Study to Evaluate the Efficacy and Safety of REGEND001 Cell Therapy on Idiopathic Pulmonary Fibrosis (IPF)
Lead Sponsor:
Regend Therapeutics
Collaborating Sponsors:
Peking Union Medical College Hospital
RenJi Hospital
Conditions:
Idiopathic Pulmonary Fibrosis
Eligibility:
All Genders
40-75 years
Phase:
PHASE2
Brief Summary
Idiopathic pulmonary fibrosis (IPF) is a serious chronic (long term) disease with injury of lung tissues. REGEND001 is a cell therapy product, made from bronchial basal cells with ability to regenerat...
Eligibility Criteria
Inclusion
- Male or female, aged between 40 to 75;
- Subjects diagnosed with IPF according to guidelines for the diagnosis of idiopathic pulmonary fibrosis 2022 edition;
- Subjects with DLCO (measured/predicted value) ≥30% and \<80%, and FVC (measured/predicted value) ≥50% within 3 months prior to screening
- Subjects tolerant to bronchofiberscope;
- Subjects tolerant to test of lung function;
- Subjects able to voluntarily sign the informed consent and cooperate with the completion of pulmonary function tests;
Exclusion
- Female subject who is pregnant, nursing, or planning to be pregnant in half a year after using this product (or male subjects planning to have a pregnant spouse);
- At the time of screening, subject who is positive in each of treponema pallidum antibody (TP-Ab), human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody test, except the following: (1) Hepatitis B virus carriers (only HBsAg positive, no hepatitis symptoms and signs, all liver function tests are normal); (2) Cured hepatitis C patients with negative result in HCV ribonucleic acid (RNA) test.
- Subject with malignant tumors or a history of malignant tumors;
- Subject with severe anemia, poorly controlled agranulocytosis and thrombocytopenia at screening;
- Subject at risk of suicide or has a history of mental illness or epilepsy at the time of screening;
- Subject with severe arrhythmias or atrioventricular block of degree II or above, shown by 12-lead Electrocardiogram (ECG);
- Subject who participated in other interventional clinical trials in the past 3 months;
- Subject assessed as inappropriate to participate in this clinical trial by investigators.
Key Trial Info
Start Date :
December 11 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 14 2025
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT06081621
Start Date
December 11 2023
End Date
March 14 2025
Last Update
September 9 2025
Active Locations (4)
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1
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
2
The Second Affiliated Hospital of Xiamen Medical College
Xiamen, Fujian, China, 361021
3
Ruijin Hospital, Shanghai Jiaotong University School Of Medicine
Shanghai, Shanghai Municipality, China, 200025
4
Renji Hospital, Shanghai Jiaotong University School Of Medicine
Shanghai, Shanghai Municipality, China, 200127