Using fat-derived proteins to treat pulmonary fibrosis

Clinical Study of Allogeneic Fat Decellularized Active Protein in the Treatment of Pulmonary Fibrosis

This study is testing whether a new treatment made from fat proteins can help people with pulmonary fibrosis breathe better.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 7 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University (Academic / other)
• Drugs / interventions: imatinib, cyclophosphamide, prednisone
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT05883293 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy and safety of allogeneic adipose-derived cyclic active protein for treating pulmonary fibrosis. A total of 7 participants will receive 2ml of nebulized Cell Free Fat Extract (CEFFE) every 3 days for a total of 7 treatments. The study employs a single-center, self-controlled design without a control group or blinding. The main objectives are to evaluate clinical efficacy and monitor any adverse events or abnormal laboratory results.

Who should consider this trial

Good fit: Ideal candidates are adults aged 30 to 80 with diagnosed pulmonary fibrosis who have not responded well to existing treatments.

Not a fit: Patients with active infections, tumors, or other significant pulmonary conditions may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could provide a novel therapeutic option for patients suffering from pulmonary fibrosis.

How similar studies have performed: While animal studies have shown promise, this approach is relatively novel in human clinical settings.

Eligibility criteria

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.

Where this trial is running

Shanghai, Shanghai

• The Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Study coordinator: WeiNing Xiong, Doctor

Conditions Pulmonary Fibrosis; Cell Free Fat Extract ，CEFFE; nebulized inhalation