Idiopathic Pulmonary Fibrosis (IPF)Early Phase 1NCT07359963
Treatment of Idiopathic Pulmonary Fibrosis (IPF) by REGEND007 Cell Therapy
A Early Phase 1 study testing REGEND007 Cell Therapy in people with Idiopathic Pulmonary Fibrosis (IPF), run by Regend Therapeutics at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis (IPF)
- What is being tested?
- REGEND007 Cell Therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 15 Feb 2026to 15 Jun 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Fourth Hospital of Zhejiang University School of Medicine
Yiwu, Zhejiang, 322000
Shaohua Zhang, Professor and Chief Physician, 086-0579-89979999, z16zsh@126.com
About this study
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).
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.
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Being tested
- REGEND007 Cell Therapy
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGEND007 Cell TherapyBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| REGEND007 Cell Therapy | Experimental | Not described Receives: Biological: REGEND007 Cell Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence and severity of drug-related adverse events (AEs)
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.
Measured: 12 weeks after the administration
Secondary outcomes (9)
The change in the actual forced vital capacity (FVC) compared to the baseline
FVC is the full amount of air that can be-exhaled with effort in a complete breath
Measured: 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
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.
Measured: 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
FEV1 is the volume of breath exhaled with effort in one second.
Measured: 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
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.
Measured: 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
DLCO is a measure of the conductance of CO across the alveolar-capillary membrane and its binding with hemoglobin.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 24 hours after administration, 4 and 12 weeks after the last administration.
The time when the first acute exacerbation of IPF occurred after administration
The time when the first acute exacerbation of IPF occurred after administration is helpful for assessing disease progression and prognosis.
Measured: Within 12 weeks after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start15 Feb 2026 (estimated)
- Primary completion15 Feb 2027 (estimated)
- Study completion15 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary Fibrosis (IPF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regend Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07359963
- Sponsor's protocol ID
- REGEND007-IPF-251
- Status last verified
- Jan 2026
- First submitted
- 13 Jan 2026
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT07359963
- Acronym / sponsor ID
- REGEND007-IPF-251
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Regend TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 15 Feb 2026 (estimated)
- Primary completion
- 15 Feb 2027 (estimated)
- Study completion
- 15 Jun 2027 (estimated)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| REGEND007 Cell Therapy | Experimental | Biological: REGEND007 Cell Therapy |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REGEND007 Cell TherapyThis 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. | Biological | REGEND007 Cell Therapy |
Primary outcome
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.
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing REGEND007 Cell Therapy in people with Idiopathic Pulmonary Fibrosis (IPF), run by Regend Therapeutics at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kai Wang, Professor and Chief Physician (086-0579-89935016, kaiw@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence and severity of drug-related adverse events (AEs) (time frame: 12 weeks after the administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.