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Completed

NCT Number: NCT06081621

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

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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Key information

Conditions

Idiopathic Pulmonary Fibrosis Lung Diseases Lung Diseases, Interstitial Pulmonary Fibrosis Respiratory Tract Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

REGEND001

Biological

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

Placebo

Biological

Placebo: Sodium chloride injection administrated by bronchoscopy.

Primary outcomes

  1. Comparison of the area under the curve (AUC) of DLCO measured values at each visit from baseline to week 24 between the REGEND001 group and the placebo group.

    Time frame: 12 and 24 weeks after treatment

    DLCO is measured by the single-breath method. Improvement is defined as an increase in DLCO from baseline.

Secondary outcomes

  1. Change from baseline in lung diffusing capacity

    Time frame: 12 and 24 weeks after treatment

    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.

Other outcomes

  1. Change from baseline in lung ventilatory capacity

    Time frame: 12 and 24 weeks after treatment

    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.

  2. Progression-free survival (PFS)

    Time frame: Within 24 weeks after treatment

    PFS refers to the time from randomization or initiation of treatment to the occurrence of disease progression or death.

  3. Change from baseline in St. George's respiratory questionnaire (SGRQ) scale

    Time frame: 12 and 24 weeks after treatment

    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.

  4. Change from baseline in 6-minute-walk test (6MWT)

    Time frame: 12 and 24 weeks after treatment

    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.

  5. Time from enrollment to all-cause death

    Time frame: up to 24 weeks(first period), 5 years (second period).

    Time from enrollment to all-cause death is used to evaluate the overall survival of the population.

  6. Blood oxygen saturation

    Time frame: 12 and 24 weeks after treatment

    Blood oxygen saturation is the measure of how much oxygen is traveling through body in red blood cells.

  7. Change from baseline in images of lung by high resolution computed tomography (HR-CT)

    Time frame: 12 and 24 weeks after treatment

    HR-CT images of lung will be analyzed to indicate the change of pulmonary structure.

  8. Change from baseline in C-reactive protein (CRP)

    Time frame: 12 and 24 weeks after treatment

    The level of CRP increases when there's inflammation in the body.

  9. Time to acute exacerbations of idiopathic pulmonary fibrosis (AE-IPF)

    Time frame: Within 24 weeks after treatment

    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.

  10. Temperature

    Time frame: Within 24 weeks after treatment

    Number of cases with abnormal body temperature.

  11. Breathing

    Time frame: Within 24 weeks after treatment

    Number of cases with abnormal breathing.

  12. Pulse

    Time frame: Within 24 weeks after treatment

    Number of cases with abnormal pulse.

  13. Blood pressure

    Time frame: Within 24 weeks after treatment

    Number of cases with abnormal blood pressure.

  14. Symptoms, physical examination

    Time frame: Within 24 weeks after treatment

    Number of cases with abnormal physical examination

  15. 12-lead ECG

    Time frame: Within 24 weeks after treatment

    Number of cases with abnormal 12-lead Electrocardiogram (ECG).

  16. Blood routine

    Time frame: Within 24 weeks after treatment

    Number of cases with abnormal laboratory test results

  17. Liver & Kidney function check

    Time frame: Within 24 weeks after treatment

    Number of cases with abnormal results in Liver & Kidney function check

  18. Blood glucose

    Time frame: Within 24 weeks after treatment

    Number of cases with abnormal results

  19. Function of blood clotting

    Time frame: Within 24 weeks after treatment

    Number of cases with abnormal function of blood clotting.

  20. Antibody testing for autoimmune diseases

    Time frame: Within 24 weeks after treatment

    Antibodies related to autoimmune diseases are tested for safety assessment

  21. Carcinoembryonic antigen (CEA)

    Time frame: Within 24 weeks after treatment

    CEA is a tumor marker used for early diagnosis of lung cancer.Clinically significant changes of this markers will be assessed.

  22. Neuron-specific enolase (NSE)

    Time frame: Within 24 weeks after treatment

    NSE is a tumor marker significantly elevated in small cell lung cancer. Clinically significant changes of this marker will be assessed

  23. Cytokeratin-19-fragment (CYFRA21-1)

    Time frame: Within 24 weeks after treatment

    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

  24. Squamous cell carcinoma antigen (SCC)

    Time frame: Within 24 weeks after treatment

    SCC is a specific marker for lung squamous cell carcinoma. Clinically significant changes of this marker will be assessed

  25. Other cases of adverse effects

    Time frame: Within 24 weeks after treatment

    Other cases of adverse effects will be recorded and compared.

Sponsors and collaborators

Lead sponsor

Regend Therapeutics

Industry

Collaborators

  • Peking Union Medical College Hospital
  • RenJi Hospital
  • Ruijin Hospital
  • Second Affiliated Hospital of Xiamen Medical College

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 13, 2023
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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