Could fat protein help lungs? tiny trial begins
NCT ID NCT05883293
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This early-stage trial tests whether an inhaled protein from donated fat tissue can help people with pulmonary fibrosis, a lung-scarring disease. Seven participants will inhale the protein every 3 days for 7 doses. The study measures safety and changes in breathing and quality of life, but has no control group, so results will be very preliminary.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Cell-free fat extract (CEFFE) from donated fat tissue
- What this could lead to
- If it works, this could point toward a new inhaled treatment to ease breathing and improve quality of life for people with pulmonary fibrosis.
- What could go wrong
- This is a very early, tiny trial with only 7 people and no comparison group. It is designed mainly to check safety, not prove effectiveness. The treatment may not work or could cause side 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
-
Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
-
About 7 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Aug 2023
- Expected to finish
-
Aug 2026
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 80 years
- Sex
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Anyone
- Healthy volunteers
-
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: 1. Patients who sign the informed consent form. 2. Age 30\~80 years old, gender is not limited. 3. Patients with pulmonary fibrosis who have obvious pulmonary fibrosis symptoms, signs, and HRCT abnormalities, and are diagnosed as pulmonary fibrosis patients specified in this protocol, and have poor effect of existing treatment regimens or do not accept existing treatment regimens Clinical basis for diagnosis of pulmonary fibrosis: 1. Abnormal pulmonary function, including restrictive ventilatory dysfunction and gas exchange disorder; 2. Typical fibrotic manifestations were found on HRCT, such as interstitial changes, grid-like changes or honeycomb lungs Exclusion Criteria: 1. Patients suffering from any of the following diseases: active tuberculosis, lung abscess, aspiration pneumonia, lung tumor, pulmonary edema, atelectasis, pneumothorax, pleural effusion, pulmonary embolism, pulmonary eosinophilic infiltration, pulmonary vasculitis and immunosuppression or immunodeficiency (including: hepatitis B surface antigen, hepatitis C antibody, AIDS antibody, syphilis antibody test positive); 2. Patients with active infection within 4 weeks; 3. Patients with acute exacerbation of pulmonary fibrosis within 4 weeks or/and those who require high-flow oxygen (oxygen concentration greater than or equal to 40% or oxygen flow greater than or equal to 5L/min), non-invasive or invasive ventilator-assisted ventilation 4. Patients with a history of tumor or current tumors; 5. The patient has a severe life-threatening disease and is expected to survive less than 12 months; 6. The patient has leukopenia (neutrophil count\< 1000/mm3); 7. Patients with severe renal impairment: creatinine clearance \< 30ml/min/1.73m2 or serum creatinine \>265μmol/L (\>3mg/dL); 8. Patients with liver disease or severe liver function impairment: ALT, AST \> 2 times the upper limit of normal value; 9. Those with central nervous system dysfunction, such as convulsions, impaired consciousness, history of epilepsy or seizures; Have a clear history of mental disorders, or a history of psychotropic substance abuse or drug abuse 10. Long-term use of glucocorticoids for treatment of more than 10 mg of prednisone or equivalent, immunosuppressants or antifibrotic drugs, such as penicillamine, colchicine, cyclosporine A, TNFα antagonists, imatinib, IFN-γ, azathioprine, cyclophosphamide; 11. Women who are pregnant, breastfeeding or do not use proper contraception; 12. Those who are allergic to known ingredients of drugs and who are known or suspected of being allergic to the active or inactive ingredients of the study drug; 13. Allergy to acetaminophen or history of hypersensitivity reactions; 14. Alcohol abuse (defined as drinking \>2 units per day/1\>4 units per week, drinking 1 unit equivalent to 360ml of beer or 45ml of spirits with 40% alcohol content or 150ml of wine) or drug abusers; 15. Any situation that the investigator believes may increase the risk of the patient or interfere with the clinical trial, and the patient is not suitable for entering the investigator.
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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.
Contacts and locations
Locations
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The Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 021, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Patients and families build a living database of pulmonary fibrosis
- Breathing exercises put to the test for scarred lungs
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