An Open Clinical Study Exploring the Safety, Tolerability, and Preliminary Efficacy of Human Umbilical Cord Mesenchymal Stem Cell Injection in the Treatment of Interstitial Lung Disease (ILD)
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 主要终点
- Maximum tolerated dose per dose (MTD)
研究概览
简要总结
Main objective: To explore the safety and tolerability of human umbilical cord mesenchymal stem cell injection in the treatment of interstitial lung disease (ILD); Secondary objective: To explore the preliminary effectiveness of human umbilical cord mesenchymal stem cell therapy for interstitial lung disease (ILD) and recommend appropriate cell therapy doses for subsequent clinical studies; Exploring the immunogenicity of human umbilical cord mesenchymal stem cell injection in the treatment of interstitial lung disease (ILD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gender not limited, age ≥ 18 years old (including threshold);
- •Clinical diagnosis of interstitial lung disease;
- •Blood biochemistry tests must meet the following criteria: alanine aminotransferase (ALT) ≤ 2.5 × ULN, aspartate aminotransferase (AST) ≤ 2.5 × ULN, total bilirubin (TBIL) ≤ 2 × ULN, direct bilirubin (DBIL) ≤ 1.5 × ULN, or creatinine (Cr) ≤ 3 × ULN;
- •The diffusion capacity of carbon monoxide (DLCO) (corrected by Hb) in lung function tests within the previous 3 months is 30% to 80% of the expected value (including 30% and 80%); Forced vital capacity (FVC) is 40% to 70% of the estimated value (including 40% and 70%)
排除标准
- •Within the first 3 days of enrollment, use high-dose corticosteroids (equivalent to methylprednisolone>240 mg/day) or irregularly use systemic corticosteroids;
- •For patients receiving immunosuppressive therapy, unstable background treatment with cyclophosphamide, mycophenolate mofetil/sodium, methotrexate, or other immunosuppressive monotherapy is not allowed (combination therapy is not allowed)
- •Diagnose IPF patients who have previously taken drugs that may cause or worsen pulmonary fibrosis;
- •Individuals with a history of mechanical ventilation or concurrent infectious pneumonia or asthma within the previous month prior to screening; Patients with airway obstruction disease (FEV1/FVC<0.7 before using bronchodilators); Patients with other clinically significant serious abnormalities in the lungs; Currently requiring oxygen therapy treatment (oxygen therapy time>15h/d);
- •Pregnant and lactating women
- •Screening for malignant tumors that have occurred within the past 5 years, excluding cervical carcinoma in situ, squamous cell carcinoma of the skin, or basal cell carcinoma that have been previously treated for curative purposes;
- •Individuals who have been hospitalized for 3 or more times due to acute exacerbation of ILD or other respiratory diseases within the past year prior to screening
- •There is evidence that subjects currently have digestive system, urinary system, cardio cerebrovascular, blood system, nervous system, mental and metabolic diseases that may affect safety, such as type 2 diabetes with poor blood sugar control, hypertension with poor blood pressure control, etc
- •have a history of abuse or drug use of psychotropic substances
- •individuals allergic to human serum albumin, anesthetics, or their components
- •Select participants who have participated in any other clinical trials within the previous 3 months;
- •individuals who have previously received stem cell therapy
- •Researchers have determined that the expected survival period may be less than 1 year;
- •Subjects who cannot tolerate bronchoscopy examination (including but not limited to: active massive hemoptysis; severe hypertension and arrhythmia;
研究组 & 干预措施
Dose escalation
Four different doses were set, and three subjects in each dose plan received human umbilical cord mesenchymal stem cell injection successively. Each subject received a single dose of 6.0*10^6, 3.0*10^7,6.0*10^7, and 9.0*10^7 cells / person.
干预措施: Human umbilical cord mesenchymal stem cell injection (Drug)
结局指标
主要结局
Maximum tolerated dose per dose (MTD)
时间窗: From the first administration to 4 weeks after administration
The maximum tolerable dose (MTD) of a single administration depends on whether dose limiting toxicity (DLT) occurs within 4 weeks after the first administration, for example (1) Hematological toxicity of grade 3 and above caused by the treatment of human umbilical cord mesenchymal stem cell injection. There are grade 3 and above non hematological toxic reactions caused by the treatment of human umbilical cord mesenchymal stem cell injection, except for the following cases, (3) Any other toxicity related to cell therapy that is higher than the baseline level is judged as clinically significant and / or unacceptable by the investigator and the sponsor, (4) There are acute exacerbations and serious adverse events (SAE) of IPF related to the treatment of human umbilical cord mesenchymal stem cell injection (which may be related, likely to be related and definitely related)
次要结局
- Preliminary efficacy evaluation：lung function(The 4th, 12th, 24th week after administration)
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]：Pulse(The 4th, 12th, 24th week after administration)
- Preliminary efficacy evaluation: St. George's respiratory questionnaire(SGRQ)(The 4th, 12th, 24th week after administration)
- Preliminary efficacy evaluation: dyspnea score(The 4th, 12th, 24th week after administration)
- Preliminary efficacy evaluation: cough score(The 4th, 12th, 24th week after administration)
- Preliminary efficacy evaluation: 6-minute walk test(The 4th, 12th, 24th week after administration)
- Preliminary efficacy evaluation: Frequency of acute exacerbation events(The 4th, 12th, 24th week after administration)
- Preliminary efficacy evaluation: High Resolution Computed Tomography scores(HRCT score)(The 4th, 12th, 24th week after administration)
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]：Blood pressure(The 4th, 12th, 24th week after administration)
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]：respiration rate(The 4th, 12th, 24th week after administration)
- Blood routine(The 4th, 12th, 24th week after administration)
- Concentration of Lung tumor markers(The 4th, 12th, 24th week after administration)
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]：body temperature(The 4th, 12th, 24th week after administration)
- Blood gas analysis(The 4th, 12th, 24th week after administration)
- Electrocardiogram(The 4th, 12th, 24th week after administration)
- Blood biochemistry(The 4th, 12th, 24th week after administration)