A Phase 1/2a Clinical Trial to Assess Safety of a Single IV Infusion of Autologous Adipose-derived Mesenchymal Stem Cells in Adults With Active Rheumatoid Arthritis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Total Number of Adverse Events and Serious Adverse Events
研究概览
简要总结
Hope Biosciences is conducting a research study of an investigational product called Hope Biosciences autologous adipose-derived mesenchymal stem cells (abbreviated as HB-adMSCs) as a possible treatment for Rheumatoid Arthritis (RA). The study purpose is to evaluate the safety profile of a single IV infusion of HB-adMSCs in subjects with clinical diagnosis of RA.
详细描述
This is a Phase 1/2a, open-label, single-dose study in subjects with active Rheumatoid Arthritis (RA). 12-15 patients will be enrolled for the study. The overall objective of this study is to evaluate the safety profile of a single IV infusion of autologous adipose-derived mesenchymal stem cells (HB-adMSCs) in subjects with clinical diagnosis of RA. The primary endpoint of this study is to measure the number and frequency of adverse event(s) and/or severe adverse event(s) throughout the study duration. The second endpoint of this study is to evaluate the ability of HB-adMSCs to alter RA-related inflammation via measuring levels of Tumor Necrosis Factor alpha (TNF-a), Interleukin-6 (IL-6), C-Reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR) and Joint Count 66/68 after a single infusion of autologous HB-adMSCs for up to 12-month post-infusion.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult male or female between the ages of 18 and 65
- •Patients have active RA as confirmed by the following criteria:
- •≥ 6 swollen joints and ≥ 6 tender joints at screening (68-joint count)
- •Abnormal CRP result OR abnormal ESR result at screening. Abnormal CRP result at screening OR abnormal ESR defined as:
- •CRP > 4.9 mg/L or ESR > 10mm/hr for men, > 20mm/hr for women
- •Patients without current established treatment, or if being treated, patients who are on a stable dose of RA therapy regimen for ≥ 4 weeks prior to screening
排除标准
- •Inability to understand and provide signed informed consent
- •Pregnancy, lactation, or, if female of childbearing potential, positive serum β-hCG at screening.
- •Currently diagnosed any malignant neoplasm. Any patient who was successfully treated for cancer and has been disease-free, with no recurrence, for at least 5 years, will be considered.
- •Uncontrolled systemic illness, including, but not limited to: hypertension (systolic >150 mm Hg or diastolic >95 mm Hg); diabetes; renal, hepatic, or cardiac failure or any laboratory abnormality that poses a safety risk to the subject such as:
- •Hemoglobin ≤8.5 g/dL
- •White blood cells (WBCs) ≤3,500/mm3 (3.5 G/L)
- •Any other illness which, in the opinion of the investigator, characterizes the subject as not being a good candidate for the study
- •Participation in another study with an investigational drug or device within 4 weeks prior to treatment or 5 half-lives of the investigational product used (whichever is longer).
- •Positive results of hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb), hepatitis B core antibody (HBcAb), hepatitis C antibody (HCV Ab), and/or human immunodeficiency virus antibody (HIV Ab) tests at screening (excluding patients who are tested positive for HBsAb alone due to a hepatitis B vaccination).
- •Positive history of Treponema pallidum.
研究组 & 干预措施
Treatment Arm
Single IV administration of autologous adipose-derived mesenchymal stem cells Baseline laboratory data will be collected prior to infusion; follow up data will be compared against baseline at 1, 3, 6 and 12 months. Joint Assessment 68 will be administered at 1, 3, 6 and 12 months.
干预措施: HB-adMSCs (Biological)
结局指标
主要结局
Total Number of Adverse Events and Serious Adverse Events
时间窗: 12 months
Total number of Adverse Events and Serious Adverse Events across all subjects over 12 months.
次要结局
- The Effect of Single Injection of HB-adMSCs on IL-6 in Patients With Acute RA(12 months)
- The Effect of Single Injection of HB-adMSCs on TNF-a in Patients With Acute RA(12 months)
- The Effect of Single Injection of HB-adMSCs on Joint Count in Patients With Acute RA.(12 months)
- The Effect of Single Injection of HB-adMSCs on CRP in Patients With Acute RA(12 months)
- The Effect of Single Injection of HB-adMSCs on ESR in Patients With Acute RA(12 months)