Treatment of Idiopathic Pulmonary Fibrosis (IPF) by REGEND007 Cell Therapy

Official title

An Exploratory Clinical Study on the Intravenous Infusion of REGEND007 (Generic Airway Basal Layer Stem Cell Preparation) for the Treatment of Idiopathic Pulmonary Fibrosis (IPF).

Overview

This study is a prospective, single-arm, dose-escalation exploratory clinical trial to investigate the safety, tolerability and preliminary efficacy of REGEND007 stem cell preparation administered by intravenous infusion in the treatment of idiopathic pulmonary fibrosis (IPF), with a follow-up period of 12 weeks.

Interventions

• Biological REGEND007 Cell Therapy
  This study's intravenous infusion dose escalation protocol is based on a 3+3 dose escalation design, with a total of 4 dose groups. Each group included 3 subjects, and the dose is gradually increased until the maximum tolerated dose(MTD) or the maximum administered dose (MAD) is reached.

Primary outcome measures

• The incidence and severity of drug-related adverse events (AEs) [Time frame: 12 weeks after the administration]

Secondary outcome measures (9)

• The change in the actual forced vital capacity (FVC) compared to the baseline [Time frame: 24 hours after administration, 4 and 12 weeks after the last administration]
• The change in forced vital capacity (FVC) actual-to-predicted ratio compared to the baseline [Time frame: 24 hours after administration, 4 and 12 weeks after the last administration.]
• The change in the actual forced expiratory volume in one second (FEV1) compared to the baseline [Time frame: 24 hours after administration, 4 and 12 weeks after the last administration]
• The change in the forced expiratory volume in one second (FEV1) actual-to-predicted ratio compared to the baseline [Time frame: 24 hours after administration, 4 and 12 weeks after the last administration]
• The change in the carbon monoxide diffusion capacity (DLCO) compared to the baseline [Time frame: 24 hours after administration, 4 and 12 weeks after the last administration]
• The change in carbon monoxide diffusion capacity (DLCO) actual-to-predicted ratio compared to the baseline [Time frame: 24 hours after administration, 4 and 12 weeks after the last administration.]
• The change in the ratio of carbon monoxide diffusion capacity to lung alveolar volume (DLCO/VA) compared to the baseline [Time frame: 24 hours after administration, 4 and 12 weeks after the last administration.]
• The change in the six-minute walk test (6MWT) compared to the baseline [Time frame: 24 hours after administration, 4 and 12 weeks after the last administration.]
• The time when the first acute exacerbation of IPF occurred after administration [Time frame: Within 12 weeks after administration]

Eligibility criteria

Inclusion criteria

• Gender is not restricted. When signing the informed consent form, the age should be between 40 and 80 years old (inclusive of the boundary value).
• Diagnosed with idiopathic pulmonary fibrosis (IPF).
• During the screening process, the six-minute walk test should be ≥ 150 meters and < 600 meters; or the lung function FVC should be > 30% of the predicted value.
• Voluntarily sign the informed consent form, be able to cooperate with the completion of research-related procedures and examinations, and be able to comprehensively describe or record the changes in the condition.

Exclusion criteria

• Female subjects who are pregnant, breastfeeding, or planning to become pregnant within one year after using this product; or male subjects whose partner is planning to become pregnant.
• Subjects selected during the screening whose estimated survival period is less than one year.
• Subjects selected during the screening who have a current or past history of malignant tumors (excluding malignant tumors with a disease-free survival of more than five years and judged by the researcher to have a relatively mild invasiveness, such as non-melanoma skin cancer, invasive cervical cancer, bladder cancer, thyroid cancer, and breast cancer, etc.).
• Subjects selected within 4 weeks before diagnosis of pneumonia (including bacterial, fungal or viral pneumonia).
• Subjects selected within 4 weeks before an acute exacerbation of IPF.
• Subjects selected within 4 weeks before having one or more results reported by pathogenological or serological tests (nucleic acid, antigen, virus culture, specific IgG antibody levels) indicating novel coronavirus infection, or suspected novel coronavirus infection (manifesting symptoms such as fever, headache, fatigue, joint pain, runny nose, sore throat, and persistent cough, and the disease course is consistent with the prevalent strain).
• Subjects selected within 4 weeks before having a history of invasive or non-invasive mechanical ventilation.
• Subjects selected during the screening who have active pulmonary tuberculosis, poorly controlled bronchial asthma, acute pulmonary embolism, severe pulmonary hypertension \[cardiac ultrasound examination > 70 mmHg\], etc.
• Subjects selected within 6 months before having a serious non-pulmonary systemic disease and judged by the researcher as not suitable to participate in this study, such as diabetes with ketoacidosis or hyperosmolar coma, acute myocardial infarction, unstable angina pectoris, NYHA heart failure grade III/IV, stroke, liver cirrhosis with severe liver dysfunction, severe renal insufficiency, etc.
• Subjects selected during the screening who have severe anemia, or controlled poorly granulocytopenia or thrombocytopenia.
• Subjects selected during the screening who have a history of suicide risk, psychiatric history or epilepsy history.
• Subjects selected during the screening who have severe malnutrition.
• Subjects selected during the screening whose 12-lead electrocardiogram shows severe arrhythmias (such as ventricular tachycardia, supraventricular tachycardia, atrial fibrillation, atrial flutter, etc.) or second-degree and above conduction abnormalities of the heart.
• Subjects selected within 4 weeks before participating in other clinical trials with intervention measures or using other biological agents for treatment.
• Researchers, collaborating researchers, research coordinators, researchers participating in the study or employees of the research center or their family members.
• Subjects selected during the screening who the researcher considers unsuitable to participate in the trial (increasing the risk for the subjects or interfering with the clinical trial).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Sequential

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• The Fourth Hospital of Zhejiang University School of Medicine — Yiwu

Identifiers

NCT: NCT07359963 · REGEND007-IPF-251

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗