Clinical trial NCT06081621: A Clinical Study to Evaluate the Efficacy and Safety of REGEND001 Cell Therapy on Idiopathic Pulmonary Fibrosis (IPF)
Official title: A Multi-center, Randomized, Double-Blinded, Parallel and Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of REGEND001 Cell Therapy in Idiopathic Pulmonary Fibrosis (IPF) Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Idiopathic Pulmonary Fibrosis
Lead sponsor: Regend Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Peking Union Medical College Hospital
name: RenJi Hospital
name: Ruijin Hospital
First posted: 2023-10-13
Enrollment: 23
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The ratio of subjects with improvement of lung carbon oxide diffusion function (DLCO)
timeFrame: 12 and 24 weeks after treatment
Secondary outcomes:
measure: Change from baseline in lung diffusing capacity
timeFrame: 12 and 24 weeks after treatment
Other outcomes:
measure: Change from baseline in lung ventilatory capacity
timeFrame: 12 and 24 weeks after treatment
measure: Progression-free survival (PFS)
timeFrame: Within 24 weeks after treatment
measure: Change from baseline in St. George's respiratory questionnaire (SGRQ) scale
timeFrame: 12 and 24 weeks after treatment
measure: Change from baseline in 6-minute-walk test (6MWT)
timeFrame: 12 and 24 weeks after treatment
measure: Time from enrollment to all-cause death
timeFrame: up to 24 weeks(first period), 5 years (second period).
measure: Blood oxygen saturation
timeFrame: 12 and 24 weeks after treatment
measure: Change from baseline in images of lung by high resolution computed tomography (HR-CT)
timeFrame: 12 and 24 weeks after treatment
measure: Change from baseline in C-reactive protein (CRP)
timeFrame: 12 and 24 weeks after treatment
measure: Time to acute exacerbations of idiopathic pulmonary fibrosis (AE-IPF)
timeFrame: Within 24 weeks after treatment
measure: Temperature
timeFrame: Within 24 weeks after treatment
measure: Breathing
timeFrame: Within 24 weeks after treatment
measure: Pulse
timeFrame: Within 24 weeks after treatment
measure: Blood pressure
timeFrame: Within 24 weeks after treatment
measure: Symptoms, physical examination
timeFrame: Within 24 weeks after treatment
measure: 12-lead ECG
timeFrame: Within 24 weeks after treatment
measure: Blood routine
timeFrame: Within 24 weeks after treatment
measure: Liver & Kidney function check
timeFrame: Within 24 weeks after treatment
measure: Blood sugar
timeFrame: Within 24 weeks after treatment
measure: Function of blood clotting
timeFrame: Within 24 weeks after treatment
measure: Antibody testing for autoimmune diseases
timeFrame: Within 24 weeks after treatment
measure: Carcinoembryonic antigen (CEA)
timeFrame: Within 24 weeks after treatment
measure: Neuron-specific enolase (NSE)
timeFrame: Within 24 weeks after treatment
measure: Cytokeratin-19-fragment (CYFRA21-1)
timeFrame: Within 24 weeks after treatment
measure: Squamous cell carcinoma antigen (SCC)
timeFrame: Within 24 weeks after treatment
measure: Other cases of adverse effects
timeFrame: Within 24 weeks after treatment
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
state: Beijing
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiaotong University School Of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Renji Hospital, Shanghai Jiaotong University School Of Medicine
state: Shanghai
Study officials:
References: