Stem cell trial aims to regrow lungs in COPD patients
NCT ID NCT07355868
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tests REGEND007, a stem cell therapy made from airway cells, in 12 people with COPD. The cells are given by IV infusion in increasing doses to see if they are safe and can help repair lung damage. The study is still recruiting and focuses on safety first.
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 cells)
- What this could lead to
- If it works, this could point toward a treatment that repairs lung tissue and improves breathing in COPD patients.
- What could go wrong
- This is a very early, small trial (12 people) focused on safety. It may not show clear benefit, and stem cell therapies carry risks like immune reactions or uncertain 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.
- Started
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Mar 2026
- Expected to finish
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Dec 2026
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 values); * Diagnosed with COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) in 2025; * During the screening process, the six-minute walk test should be ≥ 150 meters and \< 600 meters; * Voluntarily sign the informed consent form, be able to cooperate with the completion of the research-related procedures and examinations, and be able to describe or record the changes in the condition in a relatively complete manner. Exclusion Criteria: * Female subjects who are pregnant, breastfeeding, or planning to become pregnant within one year after using this product; or male subjects whose spouses are planning to become pregnant. * Subjects evaluated by the investigator at the time of screening have a survival period of less than one year. * Subjects with a current or past history of malignant tumors (excluding non-melanoma skin cancer, cervical cancer in situ, bladder cancer, thyroid cancer, and breast cancer, etc., which have a disease-free survival of more than five years and are judged by the investigator to have a relatively weak invasiveness) at the time of screening. * Subjects diagnosed with pneumonia (including bacterial, fungal, or viral pneumonia) within 4 weeks before screening. * Subjects who have experienced more than 4 episodes of moderate to severe acute exacerbation of COPD and required hospitalization within 1 year before screening. * Subjects who have one or more results of pathogen or serological tests (nucleic acid, antigen, virus culture, specific IgG antibody levels) reporting 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) within 4 weeks before screening. * Subjects with a history of invasive or non-invasive mechanical ventilation at the time of screening. * Subjects evaluated by the investigator at the time of screening have active pulmonary tuberculosis, poorly controlled bronchial asthma, acute pulmonary embolism, severe pulmonary hypertension \[cardiac ultrasound examination \> 70 mmHg\], etc. * Subjects with severe non-pulmonary systemic diseases within 6 months before screening and evaluated by the investigator as not suitable to participate in this study, such as diabetic 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 with severe anemia, or controlled poorly granulocytopenia or thrombocytopenia at the time of screening. * Subjects with a history of suicidal risk, psychiatric history or epilepsy history at the time of screening. * Subjects with severe malnutrition at the time of screening. * Subjects with 12-lead electrocardiogram showing severe arrhythmias (such as ventricular tachycardia, supraventricular tachycardia, atrial fibrillation, atrial flutter, etc.) or abnormal conduct at II degree and above of the heart. * Subjects who have participated in other clinical trials with intervention measures or received other biological agent treatment within 4 weeks before screening. * Researchers, collaborating researchers, research coordinators, researchers participating in the study, or employees of the research center or their family members of the aforementioned personnel. * Subjects considered by the investigator to be unsuitable for participation in the trial (increasing the risk of 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
RECRUITINGYiwu, Zhejiang, 322000, China
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