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

NCT05883293 | Active Not Recruiting Early Phase 1

• 1 other identifier: CEFFE-PF-2023
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical trial is to investigate the efficacy and safety of allogeneic adiphatic cyclic active protein in the treatment of pulmonary fibrosis. The main questions it aims to answer are:

1. 1.Efficacy of allogeneic adiposeactive protein in the treatment of pulmonary fibrosis
2. 2.Safety of allogeneic fat respiration active protein in the treatment of pulmonary fibrosis.

Conditions

Pulmonary Fibrosis

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Modified UK Medical Research Council Respiratory Questionnaire (mMRC)

  The change of mMRC at each time node

  baseline; 1 month, 3 months, 6 months, 12 months after treatment

• Borg grading scale

  The change of Borg grading scale at each time node

  baseline; 1 month, 3 months, 6 months, 12 months after treatment

• SGRQ Quality of Life Questionnaire

  The change of SGRQ at each time node

  baseline; 1 month, 3 months, 6 months, 12 months after treatment

Secondary Outcomes (16)

• Vital capacity (VC)

  baseline; 1 month, 3 months, 6 months, 12 months after treatment

• Forced vital capacity (FVC)

  baseline; 1 month, 3 months, 6 months, 12 months after treatment

• Forced expiratory volume in the first second (FEV1)

  baseline; 1 month, 3 months, 6 months, 12 months after treatment

• The ratio of the measured carbon monoxide dispersion to the expected value (DLCO%)

  baseline; 1 month, 3 months, 6 months, 12 months after treatment

• Adverse reactions

  1 month, 3 months, 6 months, 12 months after treatment

Study Arms (1)

Experimental group

EXPERIMENTAL

Case 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 on HRCT: such as interstitial changes, grid-like changes or honeycomb lungs;

Drug: Cell Free Fat Extract(CEFFE)

Interventions

Cell Free Fat Extract(CEFFE) DRUG

The subjects inhaled 2ml of CEFFE each time in a nebulized inhalation method, inhaling every 3 days, for a total of 7 inhalations

Experimental group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who sign the informed consent form.
• Age 30\~80 years old, gender is not limited.
• 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:
• Abnormal pulmonary function, including restrictive ventilatory dysfunction and gas exchange disorder;
• Typical fibrotic manifestations were found on HRCT, such as interstitial changes, grid-like changes or honeycomb lungs

You may not qualify if:

• 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);
• Patients with active infection within 4 weeks;
• 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
• Patients with a history of tumor or current tumors;
• The patient has a severe life-threatening disease and is expected to survive less than 12 months;
• The patient has leukopenia (neutrophil count\< 1000/mm3);
• Patients with severe renal impairment: creatinine clearance \< 30ml/min/1.73m2 or serum creatinine \>265μmol/L (\>3mg/dL);
• Patients with liver disease or severe liver function impairment: ALT, AST \> 2 times the upper limit of normal value;
• 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
• 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;
• Women who are pregnant, breastfeeding or do not use proper contraception;
• 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;
• Allergy to acetaminophen or history of hypersensitivity reactions;
• 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;
• 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.

Sponsors & Collaborators

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

Study Sites (1)

The Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 021, China

Location

MeSH Terms

Conditions

Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: May 31, 2023
• Study Start: August 14, 2023
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)