A Pilot Study: Safety and Efficacy of Allogenic Mesenchymal Stem Cell Type AFCC for Treating in Elderly Knee Osteoarthritis Patients
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Incidence of abnormal physical examination
研究概览
简要总结
Amniotic fluid mesenchymal stem cells developed for chondrogenic treatment (AFCC) are used to treat elderly patients suffering from knee osteoarthritis (OA). The injection reduces inflammation and promotes the recovery of knee function, leading to an improved quality of life.
详细描述
Ten patients, aged between 60 and 80 of both genders, who were diagnosed with knee osteoarthritis at Kellgren and Lawrence (KL) score 2-3 were selected based on strict inclusion and exclusion criteria. Each patient was treated with a single intra-articular injection of 20 million cells of amniotic fluid mesenchymal stem cells in AFCC type into an OA knee. After the treatment, they were monitored through clinical assessment and laboratory investigation, including blood chemistry test and Magnetic Resonance Imaging (MRI) of the treated knee.
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
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 60 to 80 years
- •The Visual Analog Scale (VAS) score of the subject's knee joint was greater than 4
- •Knee pain needs at least 15 days of experience.
- •The Kellgren Lawrence grade of the subject's knee joint was II/III as per the axial position X-ray.
- •Subjects who understand and voluntarily sign the consent.
排除标准
- •The subject has secondary osteoarthritis (such as other joint arthritis, major trauma on the study joint in the previous 3 months, axial deviation angle beyond 15 degrees of the bones of the knee joint)
- •The subject has other known rheumatic or inflammatory diseases (such as rheumatoid arthritis and inflammatory arthritis).
- •The subject has other conditions that cause knee joint pain (such as cancer, joint tumor)
- •The subject who awaiting knee surgery
- •The subject has an underlying disease that affects treatment during 1 year (such as cancer, liver disease, severe kidney disease, SLE)
- •The subject has a history of vertebral fracture or leg bone fracture
- •The subject has a nervous system disorder that affects balance (such as stroke or Parkinson's disease)
- •The subject has an acute or chronic infectious disease
- •The subject who had evidence of knee surgery
- •The subject who has received intra-articular steroids or other substances within the last 6 months.
- •The subject who has received symptomatic slow-acting drugs for osteoarthritis (SYSADOA) within the last 4 months
- •The subject has a deformity of the knee joint.
- •The subject has any other pathological conditions
- •The subject has a communication problem
- •The subject has claustrophobia
- •The subject who had surgery to insert a cardiac pacemaker
- •The subject who had surgery to insert an aneurysm clip
- •The subject who had surgery to insert a cochlear implant
- •The subject has any internal metallic objects (such as metal plates, surgical clips, bullets)
结局指标
主要结局
Incidence of abnormal physical examination
时间窗: Month -3, Day 0, Month 3, 6 and 12
The following examinations will be conducted: general appearance, respiratory, abdomen, nervous system, muscoskeletal system and etc. In case of abnormal conditions, they shall be recorded as an adverse event.
Incidence of abnormal laboratory test results
时间窗: Day 0, Month 3, 6 and 12
The following lab tests will be conducted: serum chemistry, haematology, liver function test. In case of abnormal results, they shall be recorded as an adverse event.
Incidence of abnormal vital sign
时间窗: Month -3, Day 0, Month 3, 6 and 12
The following assessment will be conducted: heart rate, blood pressure and temperature. In case of abnormal results, they shall be record as an adverse event.
Incidence of abnormal ECG parameters
时间窗: Day 0, Month 3, 6 and 12
The following assessments will be conducted: 12 lead ECG recordings with long Lead II, and two-dimensional echocardiography (2D ECHO; if needed). In case of abnormal conditions, they shall be recorded as an adverse event
The type of Adverse event (AE), numbers of AE and proportion of patients with AE.
时间窗: Day 0 to 7, 14, 30, Month 2 to 12
AE will be monitored and recorded by the investigator throughout the study.
次要结局
- Degree of cartilage change(Screening (Month -3), Day 0, Month 3, and Month 12)
- Pain score(Screening (Month -3), Day 0, Month 3, 6, and 12)
- Knee Injury and Osteoarthritis Outcome Score (KOOS)(Screening (Month -3), Day 0, Month 3, 6, and 12)
研究者
Tatsanee Phermthai, PhD.
Principle Invesitigator
Siriraj Hospital