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

Last updated: July 7, 2025
Sponsor: Regend Therapeutics
Overall Status: Completed

Phase

2

Condition

Idiopathic Pulmonary Fibrosis

Cystic Fibrosis

Scar Tissue

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:
June 30, 2023
Estimated Completion Date:
March 14, 2025

Connect with a study center

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

    Beijing, Beijing
    China

    Site Not Available

  • The Second Affiliated Hospital of Xiamen Medical College

    Xiamen, Fujian 361021
    China

    Site Not Available

  • Renji Hospital, Shanghai Jiaotong University School Of Medicine

    Shanghai, Shanghai 200127
    China

    Site Not Available

  • Ruijin Hospital, Shanghai Jiaotong University School Of Medicine

    Shanghai, Shanghai 200025
    China

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.