Back to resultsA Clinical Study to Evaluate the Efficacy and Safety of REGEND001 Cell Therapy on Idiopathic Pulmonary Fibrosis (IPF)
Primary Purpose
Idiopathic Pulmonary Fibrosis
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
REGEND001
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis
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.
Sites / Locations
- Peking Union Medical College Hospital, Chinese Academy of Medical SciencesRecruiting
- Ruijin Hospital, Shanghai Jiaotong University School Of MedicineRecruiting
- Renji Hospital, Shanghai Jiaotong University School Of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
REGEND001
Placebo
Arm Description
Outcomes
Primary Outcome Measures
The ratio of subjects with improvement of lung carbon oxide diffusion function (DLCO)
DLCO is measured by the single-breath method. Improvement is defined as an increase in DLCO from baseline.
Secondary Outcome Measures
Change from baseline in lung diffusing capacity
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.
Full Information
NCT ID
NCT06081621
First Posted
September 17, 2023
Last Updated
October 7, 2023
Sponsor
Regend Therapeutics
Collaborators
Peking Union Medical College Hospital, RenJi Hospital, Ruijin Hospital
1. Study Identification
Unique Protocol Identification Number
NCT06081621
Brief Title
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 20, 2023 (Anticipated)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regend Therapeutics
Collaborators
Peking Union Medical College Hospital, RenJi Hospital, Ruijin Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
REGEND001
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
REGEND001
Intervention Description
REGEND001: 1-1.5×10^6 bronchial basal cells/kg administrated by bronchoscopy.
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Placebo: Sodium chloride injection administrated by bronchoscopy.
Primary Outcome Measure Information:
Title
The ratio of subjects with improvement of lung carbon oxide diffusion function (DLCO)
Description
DLCO is measured by the single-breath method. Improvement is defined as an increase in DLCO from baseline.
Time Frame
12 and 24 weeks after treatment
Secondary Outcome Measure Information:
Title
Change from baseline in lung diffusing capacity
Description
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.
Time Frame
12 and 24 weeks after treatment
Other Pre-specified Outcome Measures:
Title
Change from baseline in lung ventilatory capacity
Description
Forced vital capacity (FVC) and forced expiratory volume in one second (FEV1) will be used to evaluate the lung ventilatory capacity. FVC indicates the volume of air that can forcibly be blown out after full inspiration. FEV1 is the volume of breath exhaled with effort in one second.
Time Frame
12 and 24 weeks after treatment
Title
Progression-free survival (PFS)
Description
PFS refers to the time from randomization or initiation of treatment to the occurrence of disease progression or death.
Time Frame
Within 24 weeks after treatment
Title
Change from baseline in St. George's respiratory questionnaire (SGRQ) scale
Description
Quality of life was assessed by St. George's respiratory questionnaire (SGRQ) scale. Total score, ranged from 0 to 100, is the sum of points from all items. A higher value represents a worse outcome.
Time Frame
12 and 24 weeks after treatment
Title
Change from baseline in 6-minute-walk test (6MWT)
Description
The 6MWT is a commonly used test for the objective assessment of functional exercise capacity by testing the distance patients can walk at the fastest speed within 6 minutes.
Time Frame
12 and 24 weeks after treatment
Title
Time from enrollment to all-cause death
Description
Time from enrollment to all-cause death is used to evaluate the overall survival of the population.
Time Frame
up to 24 weeks(first period), 5 years (second period).
Title
Blood oxygen saturation
Description
Blood oxygen saturation is the measure of how much oxygen is traveling through body in red blood cells.
Time Frame
12 and 24 weeks after treatment
Title
Change from baseline in images of lung by high resolution computed tomography (HR-CT)
Description
HR-CT images of lung will be analyzed to indicate the change of pulmonary structure.
Time Frame
12 and 24 weeks after treatment
Title
Change from baseline in C-reactive protein (CRP)
Description
The level of CRP increases when there's inflammation in the body.
Time Frame
12 and 24 weeks after treatment
Title
Time to acute exacerbations of idiopathic pulmonary fibrosis (AE-IPF)
Description
AE-IPF is an often deadly complication of IPF, which is defined as an acute, clinically significant respiratory deterioration characterized by evidence of new widespread alveolar abnormality.
Time Frame
Within 24 weeks after treatment
Title
Temperature
Description
Number of cases with abnormal body temperature.
Time Frame
Within 24 weeks after treatment
Title
Breathing
Description
Number of cases with abnormal breathing.
Time Frame
Within 24 weeks after treatment
Title
Pulse
Description
Number of cases with abnormal pulse.
Time Frame
Within 24 weeks after treatment
Title
Blood pressure
Description
Number of cases with abnormal blood pressure.
Time Frame
Within 24 weeks after treatment
Title
Symptoms, physical examination
Description
Number of cases with abnormal physical examination
Time Frame
Within 24 weeks after treatment
Title
12-lead ECG
Description
Number of cases with abnormal 12-lead Electrocardiogram (ECG).
Time Frame
Within 24 weeks after treatment
Title
Blood routine
Description
Number of cases with abnormal laboratory test results
Time Frame
Within 24 weeks after treatment
Title
Liver & Kidney function check
Description
Number of cases with abnormal results in Liver & Kidney function check
Time Frame
Within 24 weeks after treatment
Title
Blood sugar
Description
Number of cases with abnormal results
Time Frame
Within 24 weeks after treatment
Title
Function of blood clotting
Description
Number of cases with abnormal function of blood clotting.
Time Frame
Within 24 weeks after treatment
Title
Antibody testing for autoimmune diseases
Description
Antibodies related to autoimmune diseases are tested for safety assessment
Time Frame
Within 24 weeks after treatment
Title
Carcinoembryonic antigen (CEA)
Description
CEA is a tumor marker used for early diagnosis of lung cancer.Clinically significant changes of this markers will be assessed.
Time Frame
Within 24 weeks after treatment
Title
Neuron-specific enolase (NSE)
Description
NSE is a tumor marker significantly elevated in small cell lung cancer. Clinically significant changes of this marker will be assessed
Time Frame
Within 24 weeks after treatment
Title
Cytokeratin-19-fragment (CYFRA21-1)
Description
CYFRA21-1 is a tumor marker which is valuable for the pathological classification and prognosis evaluation of lung cancer. Clinically significant changes of this marker will be assessed
Time Frame
Within 24 weeks after treatment
Title
Squamous cell carcinoma antigen (SCC)
Description
SCC is a specific marker for lung squamous cell carcinoma. Clinically significant changes of this marker will be assessed
Time Frame
Within 24 weeks after treatment
Title
Other cases of adverse effects
Description
Other cases of adverse effects will be recorded and compared.
Time Frame
Within 24 weeks after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zuojun Xu, M.D.
Phone
+86-10-69156114
Email
xuzj@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jeffery Ren
Phone
+86-16602112059
Email
renjie@regend.cn
Facility Information:
Facility Name
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zuojun Xu, M.D.
First Name & Middle Initial & Last Name & Degree
Zuojun Xu
Facility Name
Ruijin Hospital, Shanghai Jiaotong University School Of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiajie Wu
Phone
+86-21-64370045
Email
rujin_gcp@126.com
First Name & Middle Initial & Last Name & Degree
Jieming Qu, M.D.
Facility Name
Renji Hospital, Shanghai Jiaotong University School Of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoyu Chen
Phone
+86-21-68383223
Email
rjyljg_new@163.com
First Name & Middle Initial & Last Name & Degree
Handong Jiang, M.D.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Clinical Study to Evaluate the Efficacy and Safety of REGEND001 Cell Therapy on Idiopathic Pulmonary Fibrosis (IPF)
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