Multicenter, Randomized, Double-Blind, Placebo Controlled Phase Ⅱb Clinical Trial to Evaluate Efficacy and Safety of JOINTSTEM in Patients With Degenerative Arthritis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- WOMAC score
研究概览
简要总结
The purpose of this study is to investigate the efficacy and safety of autologous transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with Knee Osteoarthritis.
详细描述
JOINTSTEM is an OA treatment that uses autologous adipose-derived mesenchymal stem cells. As it does not use allogenic tissues and is incubated without additional genetic modification or mechanical and chemical modification through differentiation, it is classified as 'autologous cell therapy' and is completely free of immunologic rejection.
It primarily aims to improve pain and joint function, and secondary, to regenerate cartilage. The intra-articular injection of JOINTSTEM is expected to stimulate the regeneration and growth of cartilage, and to innovatively improve pain and joint function with cartilage regeneration within six months.
The subjects of this therapy were regenerative patients with K&L grade 2~4 aged 18 or older. JOINTSTEM is expected to be used in patients who have significantly damage cartilage due to its cartilage regeneration ability, in addition to its improvement of pain and joint performance. A;sp. Patients who had already undergone knee arthroplasty can delay their additional surgery with the use of JOINTSTEM. For dose who still have their own cartilage, arthroplasty is not an immediate treatment option, and osteoporosis patients who cannot undergo arthroplasty due to their advanced age can receive JOINTSTEM.
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, Investigator)
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
- •Age 18 and older, male and female
- •Patients must consent in writing to participate in the study by signing and dating an informed consent document
- •Diagnosis of osteoarthritis by ACR osteoarthritis of the knee
- •Diagnosis of osteoarthritis by radiographic criteria of Kellgren and Lawrence grade 2-4
- •More than Grade 4 (0~10 point numeric scale) pain at least for 12 weeks
- •Diagnosis of osteoarthritis of class Ⅰ~Ⅲ by ACR(American College of Rheumatology Criteria) Global functional criteria
- •Patient who agree with contraception
排除标准
- •Preparing for Pregnancy or Pregnant women or lactating mothers.
- •Patients with Body Mass Index (BMI) >
- •Patients with other disease including
- •: Septic arthritis, Rheumatoid or Inflammatory joint disease, Crystalline disease (gout or pseudogout), Paget disease, Articular fractures, Ochronosis, Acromegaly, Hemochromatosis, Wilson's disease, Osteochondromatosis, Hereditary disorder
- •Patients with serious condition internal medicine disease
- •Patients with positive human immunodeficiency (HIV), hepatitis B (HBV), hepatitis C (HCV), syphilis at screening indicative of current of pass infection.
- •Patient with behavioral disorders, cognitive disorders and chronic mental symptoms
- •Patient with significant neurologic or psychiatric disorders
- •Patients who alcohol, drug abuse history
- •Patients who had participated in other clinical trials within 12 weeks prior to this study.
- •Patients who received any drug by intra-articular injection for treatment within 2 months prior to this enrollment.
- •Patients who experienced as the knee joint cartilage and stem cell therapy
- •Patients who the principal investigator considers inappropriate for the clinical trial due to any other reasons than those listed above
- •Patients who penicillin hypersensitivity reactions -
研究组 & 干预措施
Jointstem
Autologous Adipose Tissue derived MSCs
干预措施: JOINTSTEM (Biological)
Saline solution
Sodium chloride
干预措施: Saline solution (Drug)
结局指标
主要结局
WOMAC score
时间窗: 24 weeks
Pain, stiffness, and physical function of the knee will be measured by the Western Ontario and McMaster Universities (WOMAC)
次要结局
- X-ray(24 weeks)
- MRI scan(24 weeks)
- ROM(24 weeks)
- SF(Short Form)-36 Score(24 weeks)
- Overall satisfaction(24 weeks)
- KOOS (Knee Injury & Osteoarthritis Outcome Score)(24 weeks)
- Arthroscopy evaluation(24 weeks)
- WOMAC 3 subscale(24 weeks)
- Global assessment of disease activity(24 weeks)
- Histological evaluation(24 weeks)
- VAS(24 weeks)
- IKDC(24 weeks)
- Quadriceps power(24 weeks)
- effusion(24 weeks)
- Ligament laxity(24 weeks)
- Crepitus(24 weeks)
- Medial joint line tenderness(24 weeks)
- Pes tenderness(24 weeks)