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

Last updated: March 16, 2026
Sponsor: Regend Therapeutics
Overall Status: Completed

Phase

2

Condition

Pulmonary Fibrosis

Cystic Fibrosis

Idiopathic Pulmonary Fibrosis

Treatment

REGEND001

Placebo

Clinical Study ID

NCT06081621
REGEND001-IPF-231-V1.3
  • Ages 40-75
  • All Genders

Study 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

Inclusion Criteria:

  • Male or female, aged between 40 to 75;

  • Subjects diagnosed with IPF according to guidelines for the diagnosis of idiopathicpulmonary 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 thecompletion of pulmonary function tests;

Exclusion

Exclusion Criteria:

  • Female subject who is pregnant, nursing, or planning to be pregnant in half a yearafter 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 pallidumantibody (TP-Ab), human immunodeficiency virus (HIV) antibody, hepatitis B surfaceantigen (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 negativeresult in HCV ribonucleic acid (RNA) test.

  • Subject with malignant tumors or a history of malignant tumors;

  • Subject with severe anemia, poorly controlled agranulocytosis and thrombocytopeniaat screening;

  • Subject at risk of suicide or has a history of mental illness or epilepsy at thetime 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 3months;

  • Subject assessed as inappropriate to participate in this clinical trial byinvestigators.

Study Design

Total Participants: 23
Treatment Group(s): 2
Primary Treatment: REGEND001
Phase: 2
Study Start date:
December 11, 2023
Estimated Completion Date:
March 14, 2025

Connect with a study center

  • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality
    China

    Site Not Available

  • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

    Beijing 1816670, Beijing Municipality 2038349
    China

    Site Not Available

  • The Second Affiliated Hospital of Xiamen Medical College

    Xiamen, Fujian 361021
    China

    Site Not Available

  • The Second Affiliated Hospital of Xiamen Medical College

    Xiamen 1790645, Fujian 1811017 361021
    China

    Site Not Available

  • Renji Hospital, Shanghai Jiaotong University School Of Medicine

    Shanghai, Shanghai Municipality 200127
    China

    Site Not Available

  • Ruijin Hospital, Shanghai Jiaotong University School Of Medicine

    Shanghai, Shanghai Municipality 200025
    China

    Site Not Available

  • Renji Hospital, Shanghai Jiaotong University School Of Medicine

    Shanghai 1796236, Shanghai Municipality 1796231 200127
    China

    Site Not Available

  • Ruijin Hospital, Shanghai Jiaotong University School Of Medicine

    Shanghai 1796236, Shanghai Municipality 1796231 200025
    China

    Site Not Available

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