Clinical Study of Allogeneic Fat Decellularized Active Protein in the Treatment of Pulmonary Fibrosis
试验速览
- 阶段
- 早期 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Borg grading scale
研究概览
简要总结
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:
- Efficacy of allogeneic adiposeactive protein in the treatment of pulmonary fibrosis
- Safety of allogeneic fat respiration active protein in the treatment of 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.
详细描述
- Research purpose:
Main Objective: To study the efficacy and safety of allogeneic adiphacyclic active protein in the treatment of pulmonary fibrosis, the main observation and evaluation indicators included: clinical efficacy, clinical adverse events and abnormal laboratory tests.
The basis of the question:
Animal experiments have found that fat decellularization active protein has a certain improvement effect in bleomycin-induced mouse pulmonary fibrosis model. At present, domestic clinical studies have found that fat acellular active protein is safe for the treatment of human diseases and has no obvious side effects. Therefore, in this study, the allogeneic adipo-decellularized active protein was treated with aerosol inhalation in the treatment of pulmonary fibrosis to observe its efficacy and safety. 2. Research Design:
Overall design: Single-center, self-controlled experimental design was adopted, no control group was set up, and no blinding method was adopted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Experimental group
Case Inclusion Criteria:
- 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 on HRCT: such as interstitial changes, grid-like changes or honeycomb lungs;
干预措施: Cell Free Fat Extract(CEFFE) (Drug)
结局指标
主要结局
Borg grading scale
时间窗: baseline; 1 month, 3 months, 6 months, 12 months after treatment
The change of Borg grading scale at each time node
Modified UK Medical Research Council Respiratory Questionnaire (mMRC)
时间窗: baseline; 1 month, 3 months, 6 months, 12 months after treatment
The change of mMRC at each time node
SGRQ Quality of Life Questionnaire
时间窗: baseline; 1 month, 3 months, 6 months, 12 months after treatment
The change of SGRQ at each time node
次要结局
- 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)
- 6-minute walk test(baseline; 1 month, 3 months, 6 months, 12 months after treatment)
- Pressure of oxygen in blood gases(baseline; 1 month, 3 months, 6 months, 12 months after treatment)
- Complete blood count(Safety and tolerability)(baseline; 1 month, 3 months, 6 months, 12 months after treatment)
- Alanine aminotransferase(Safety and tolerability)(baseline; 1 month, 3 months, 6 months, 12 months after treatment)
- aspartate aminotransferase(Safety and tolerability)(baseline; 1 month, 3 months, 6 months, 12 months after treatment)
- r-glutamyl transferase(Safety and tolerability)(baseline; 1 month, 3 months, 6 months, 12 months after treatment)
- alkaline phosphatase(Safety and tolerability)(baseline; 1 month, 3 months, 6 months, 12 months after treatment)
- creatinine(Safety and tolerability)(baseline; 1 month, 3 months, 6 months, 12 months after treatment)
- urea nitrogen(Safety and tolerability)(baseline; 1 month, 3 months, 6 months, 12 months after treatment)
- uric acid(Safety and tolerability)(baseline; 1 month, 3 months, 6 months, 12 months after treatment)
- electrocardiogram(Safety and tolerability)(baseline; 1 month, 3 months, 6 months, 12 months after treatment)