A Clinical Study to Evaluate the Efficacy and Safety of REGEND001 Cell Therapy on Idiopathic Pulmonary Fibrosis (IPF)

Phase 2

Completed

• Conditions: Idiopathic Pulmonary Fibrosis
• Interventions: Biological: Placebo; Biological: REGEND001

• Registration Number: NCT06081621
• Lead Sponsor: Regend Therapeutics

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 regenerate lung tissue, is promising to IPF treatment. This is a multi-center, randomized, double-blinded, parallel and placebo-controlled phase II clinical study to evaluate the efficacy and safety of REGEND001 in IPF patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-30
• Study First Submitted: 2023-09-17
• Study First Submitted QC: 2023-10-07
• Study First Posted: 2023-10-13
• Primary Completion: 2025-03-14
• Study Completion: 2025-03-14
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-06
• Last Update Posted: 2025-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• 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 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 Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
REGEND001	REGEND001	-

Primary Outcome Measures

Name	Time	Method
The ratio of subjects with improvement of lung carbon oxide diffusion function (DLCO)	12 and 24 weeks after treatment	DLCO is measured by the single-breath method. Improvement is defined as an increase in DLCO from baseline.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in lung diffusing capacity	12 and 24 weeks after treatment	DLCO will be used to evaluate the lung diffusing capacity. DLCO test refers to the diffusing capacity for carbon monoxide in the lungs. It's a type of pulmonary function test that helps to assess how well gas is exchanged between the lungs and the bloodstream.

Trial Locations

Locations (3)

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China

Ruijin Hospital, Shanghai Jiaotong University School Of Medicine; 🇨🇳 Shanghai, Shanghai, China

Renji Hospital, Shanghai Jiaotong University School Of Medicine; 🇨🇳 Shanghai, Shanghai, China