Phase 2 Study to Assess Safety & Tolerability of a Single Injection Into the Knee Joint of Two Different Doses of MSB-CAR001 Combined With Hyaluronan Compared to Hyaluronan Alone in Patients Who Have Undergone an ACL Reconstruction
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- To determine the overall safety of MSB-CAR001 plus carrier using physical examinations, vital signs, treatment emergent adverse events (TEAEs), and the results of clinical lab tests (hematology, serum chemistry, inflammation, and immunology).
研究概览
简要总结
The purpose of this study is to evaluate safety and preliminary efficacy of MSB-CAR001 in subjects who have recently undergone an Anterior Cruciate Ligament Reconstruction
详细描述
This is a prospective, single center, randomized, double blind, controlled Phase 1b/2a study designed to evaluate the safety and tolerability of a single injection into the knee joint of two different doses of MPCs combined with Hyaluronan compared to Hyaluronan alone in patients who have recently undergone an Anterior Cruciate Ligament Reconstruction.
All subjects in this study have undergone unilateral ACL reconstruction surgery within six months of injury. MSB-CAR001 plus Hyaluronan at one of two doses or Hyaluronan alone will be injected into the knee joint.
After the screening and injection visits, each subject will be evaluated clinically within 3 days and 28 days after surgery, and at 2, 3, 6, 9, 12, 18, and 24 months after surgery. The radiographical exams will be performed at 6, 12, 18, and 24 months after surgery.
Subjects will be evaluated at 24 months after surgery for safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females at least 18 years of age, but not older than 40
- •ACL injury requiring reconstruction
- •Have undergone unilateral ACL reconstruction surgery within six months of injury;
- •Willing and able to undertake a standardized rehabilitation protocol
- •ACL graft used is autograft
- •Willingness to participate in follow-up for 24 months from the time of initial treatment
- •Ability to understand and willingness to sign consent form
排除标准
- •Women who are pregnant or breast feeding or planning to become pregnant during the study
- •Previous allergic reaction to Hyaluronan
- •Systemic or local infection at the screen visit or at the time of the study injection
- •History of any autoimmune disease, such as, systemic lupus erythematosus, Addison's disease, Crohn's disease, or rheumatoid arthritis
- •Treatment with immunosuppression therapy within 6 months prior to screen (visit 1)
- •Acute or chronic infectious disease, including but not limited to human immunodeficiency virus (HIV);
- •Treatment and /or uncompleted follow-up treatment of any investigational therapy within 6 months before the procedure and /or intent to participate in any other investigational drug or cell therapy study during the 24 month follow-up period of this study;
- •Recipient of prior allogeneic stem cell/progenitor cell therapy
- •Undergoing a simultaneous procedure to the opposite knee
- •20% or greater anti-human leukocyte antigen (HLA) antibody titer and/or has antibody specificities to donor HLA antigens;
- •Known sensitivities to bovine (cow), murine (mouse), chicken products and/or dimethylsulfoxide (DMSO). Previous allergic reaction to Hyaluronan;
- •History or current evidence of alcohol or drug abuse or is a recreational user of illicit drugs or prescription medications
- •History of prior surgery to the study knee joint
- •History of malignancy (excluding basal cell carcinoma that has been successfully excised)
- •Chondral lesions noted at time of surgical reconstruction greater than Grade 1a on any surfaces
研究组 & 干预措施
Hyaluronan Alone
Hyaluronan Alone
干预措施: MSB-CAR001 Combined With Hyaluronan (Biological)
Hyaluronan Alone
Hyaluronan Alone
干预措施: Hyaluronan (Drug)
MSB-CAR001
Single Dose of MSB-CAR001 Combined With Hyaluronan
干预措施: MSB-CAR001 Combined With Hyaluronan (Biological)
结局指标
主要结局
To determine the overall safety of MSB-CAR001 plus carrier using physical examinations, vital signs, treatment emergent adverse events (TEAEs), and the results of clinical lab tests (hematology, serum chemistry, inflammation, and immunology).
时间窗: 2 years
次要结局
- To evaluate the overall efficacy with MSB-CAR001 plus Hyaluronan compared to Hyaluronan alone using MRI scans and x-ray of the involved knee joint and access the change in outcomes (KOOS, SF-36) and pain (VAS)(2 years)