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

January 13, 2026 updated by: Regend Therapeutics

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).

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Kai Wang, Professor and Chief Physician
  • Phone Number: 086-0579-89935016
  • Email: kaiw@zju.edu.cn

Study Locations

  • China
    • Zhejiang
      • Yiwu, Zhejiang, China, 322000
        • The Fourth Hospital of Zhejiang University School of Medicine
        • Contact:
          • Shaohua Zhang, Professor and Chief Physician
          • Phone Number: 086-0579-89979999
          • Email: z16zsh@126.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: REGEND007 Cell Therapy
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The incidence and severity of drug-related adverse events (AEs)
Time Frame: 12 weeks after the administration
All adverse medical events that occur from the time the subject signs the informed consent form. These can manifest as symptoms, signs, diseases, or abnormal laboratory test results, but they do not necessarily have a causal relationship with the investigational drug.
12 weeks after the administration

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
FVC is the full amount of air that can be-exhaled with effort in a complete breath
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 FVC actual-to-predicted ratio is a crucial indicator in pulmonary function tests, and it is mainly used to determine whether there is restrictive ventilation dysfunction.
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
FEV1 is the volume of breath exhaled with effort in one second.
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 FEV1 actual-to-predicted ratio is a crucial indicator in pulmonary function tests, representing the percentage relationship between the actual measured value of the first-second forced expiratory volume (FEV1) and the predicted value calculated based on individual characteristics. Under normal circumstances, the actual measured value of FEV1 should reach more than 80% of the predicted value.
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
DLCO is a measure of the conductance of CO across the alveolar-capillary membrane and its binding with hemoglobin.
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.
DLCO actual-to-predicted ratio is a crucial indicator in pulmonary function testing, used to assess the oxygen exchange capacity and efficiency of the alveoli.
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.
DLCO/VA is also known as the diffusion constant, since the diffusion amount is affected by the alveolar ventilation volume, a decrease in alveolar ventilation volume can lead to a reduction in DLCO. Therefore, this value is often used for correction to eliminate the influence of lung volume on the diffusion amount.
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.
6MWT is one of the commonly used methods in clinical practice for assessing a patient's cardiac and pulmonary functions, which involves measuring the distance that a patient can walk quickly on a flat and hard surface within 6 minutes.
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
The time when the first acute exacerbation of IPF occurred after administration is helpful for assessing disease progression and prognosis.
Within 12 weeks after administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Regend Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 15, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 13, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REGEND007-IPF-251

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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