Clinical Study of Allogeneic Adipovarian Active Protein in the Treatment of Severe Idiopathic Pulmonary Fibrosis

• Status: Recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this clinical trail is to study the efficacy and safety of allogeneic adipocyclical active protein in the treatment of severe idiopathic pulmonary fibrosis.

The main questions it aims to answer are:

1. Efficacy of allogeneic adipromic active protein in the treatment of severe idiopathic pulmonary fibrosis

2. Safety of allogeneic adipovularic active protein in the treatment of severe idiopathic pulmonary fibrosis.

A total of 7 participants will be enrolled. Participants will be asked that they will receive 2ml of each nebulized inhalation Cell Free Fat Extract (CEFFE), inhaled every 3 days, for a total of 7 nebulized inhalation treatments.

The clinical trial was designed using a single-center, self-controlled trial with no control group and no blinding.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Criteria

Inclusion Criteria:

1. Patients who sign the informed consent form.

2. Age 30~80 years old, gender is not limited.

3. Patients with IPF with obvious IPF symptoms, signs, HRCT abnormalities, diagnosed as IPF specified in this protocol, DLCO < 40% of the predicted value, and the existing treatment regimen is not effective or does not accept the existing treatment regimen

Exclusion Criteria:

1. Patients with any of the following diseases: active tuberculosis, lung abscess, aspiration pneumonia, lung tumors, 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 IPF within 4 weeks or/and requiring 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.