Stem cells injected for lung scarring: early trial begins
NCT ID NCT07359963
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial will test a stem cell product called REGEND007 in 12 people with idiopathic pulmonary fibrosis (IPF), a disease that scars the lungs and makes breathing hard. The stem cells are given through an IV, and the main goal is to check safety and find the right dose. Researchers will also watch for any signs that lung function improves over 12 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- REGEND007 (airway basal layer stem cell preparation)
- What this could lead to
- If successful, this could point toward a new treatment for idiopathic pulmonary fibrosis, a serious lung disease with few options.
- What could go wrong
- This is a very early, small trial (12 people) testing only safety and dosing. It may not show any benefit, and stem cell therapies carry risks like infusion reactions or unknown long-term effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The Fourth Hospital of Zhejiang University School of Medicine
Yiwu, Zhejiang, 322000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Which finger or earlobe? a study tests the best spot for oxygen monitoring in lung disease
- Can a new drug slow lung scarring in IPF?
- Blood tests could unlock early clues for three major lung diseases
- AI could uncover hidden lung disease in routine chest X-Rays