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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-11

Study Completion Date

2025-03-14

Brief Summary

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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.

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Detailed Description

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Conditions

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Idiopathic Pulmonary Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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REGEND001

Group Type EXPERIMENTAL

REGEND001

Intervention Type BIOLOGICAL

REGEND001: 1-1.5×10\^6 bronchial basal cells/kg administrated by bronchoscopy.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Placebo: Sodium chloride injection administrated by bronchoscopy.

Interventions

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REGEND001

REGEND001: 1-1.5×10\^6 bronchial basal cells/kg administrated by bronchoscopy.

Intervention Type BIOLOGICAL

Placebo

Placebo: Sodium chloride injection administrated by bronchoscopy.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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 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 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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No