Clinical Research on Intra-articular Injection of Human Autologous MSCs in Treatment of Knee OA
试验速览
- 阶段
- 2 期
- 入组人数
- 1
- 主要终点
- adverse events
研究概览
简要总结
In this study, researchers want to determine the safety of MSCs that a patient can tolerate without causing side effects. Moreover researchers will also be looking at the function of the knee over time, which may give them some insight on the usefulness of MSCs as a treatment option.
详细描述
Osteoarthritis (OA) is one of the most common forms of arthritis. It is a lasting condition in which the material that cushions the joints, called cartilage, breaks down. This causes the bones to rub against each other, causing inflammation, stiffness, pain and loss of joint movement. Currently, there are few effective treatments available for patients suffering from OA.
Mesenchymal stem cells (MSCs) are cells that have the ability to self-regenerate, which means they have the ability to make copies of themselves and to turn into other kinds of cells (e.g. cartilage cells). Stem cell science shows much promise for the future treatment of osteoarthritis, but much of the research is still in the early stages. In this study, researchers want to determine the safety of MSCs that a patient can tolerate without causing side effects. Moreover researchers will also be looking at the function of the knee over time, which may give them some insight on the usefulness of MSCs as a treatment option.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double blind
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 40-75 years of age with symptomatic moderate to severe (Kellgren-Lawrence III or IV) primary osteoarthritis of the knee
- •Idiopathic or secondary osteoarthritis of the knee with grade 2,3, or 4 radiographic severity, as defined by the modified Kellgren-Lawrence classification
- •No history of prior intra-articular cortisone, hyaluronic acid, or platelet-rich plasma injection within the previous six months
- •No history of prior arthroscopic knee surgery or open knee surgery on the ipsilateral side within the past year
- •Adequate bone marrow, liver, and renal functions
- •Body weight >40 kg
- •Body Mass Index <40
- •Negative for (HIV, HTLV1&2, Hep A, B, C, syphilis) infection as determined by approved serological testing
- •Negative for pregnancy as determined by a serum pregnancy test. Females of childbearing potential will be required to practice abstinence or use an effective form of contraception for 12 months following their MSC injection.
- •Ability to provide written informed consent.
排除标准
- •Patients with clinically unstable knee due to the presence of a complete anterior cruciate ligament, posterior cruciate ligament, medial collateral ligament and/or posterolateral corner tear
- •Patients with varus or valgus malalignment >5 degrees as measured by 4 foot standing antero-posterior radiographs
- •Patients with a history of a previous subtotal medial or lateral meniscectomy
- •Patients with a history of septic arthritis in the affected joint
- •Patients with a history of a prior intra-articular knee fracture
- •Severe bleeding diathesis
- •Contraindication to bone marrow aspiration and/or biopsy
- •Active infection
- •Bone marrow failure
- •Patients who have previously received radiotherapy to the pelvis
- •Patients who have been on chemotherapy from within a year of the date of informed
- •Patients with positive serological test for (HIV, HTLV1&2, Hep A, B, C, syphilis)
- •Pregnancy or risk of pregnancy (this includes participants that are not willing to practice active contraception for the duration of the study)
- •Patients with unforeseen conditions that are deemed unsafe or inappropriate for the study (e.g. patients who are claustrophobic and cannot undergo an MRI) as per the discretion of the principal investigator
研究组 & 干预措施
sodium hyaluronate
Sodium hyaluronate administered into the knee joint once
干预措施: Sodium Hyaluronate (Drug)
Placenta Derived Mesenchymal Stem Cell
Placenta Derived Mesenchymal Stem Cell administered into the knee joint once
干预措施: Placenta Derived Mesenchymal Stem Cell (Biological)
结局指标
主要结局
adverse events
时间窗: 1 Year
Number of participants with adverse events as measure of safety and tolerability
次要结局
- radiographic evidence(1 Year)
- SF-36(1 Year)
- WOMAC assessment(1 Year)
- VAS(1 Year)
研究者
YU TANG
Dr.
Affiliated Hospital of Jiangsu University