Peripheral-blood Cell Purification for PBMCs (PCP-PBMCs) Injection for Knee Osteoarthritis (PCP-PBMCs-KOA)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 240
- 试验地点
- 4
- 主要终点
- Mean Reduction in Numeric Rating Scale (NRS) Score
研究概览
简要总结
The goal of this Phase II/III, double-blinded, multicenter clinical trial is to assess the clinical efficacy of autologous peripheral blood mononuclear cells (PBMCs) in the management of knee osteoarthritis (KOA). The main questions it aims to answer are:
- To determine the safety of the PCP-PBMCs injection
- To compare the long-term efficacy between PCP-PBMCs and methylprednisolone on pain relief and motor function restoration
- To analyze improving quality of life after the PCP-PBMCs treatment.
详细描述
240 patients from both genders diagnosed with knee osteoarthritis, will be enrolled according to inclusion and exclusion criteria. These patients will be randomly injected with 100-200 million PBMCs, 20-60 million PBMCs or methylpredinisolone. They are then followed by clinical assessment, laboratory investigations as well as X-ray imaging of the injected knee.
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)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Tibiofemoral osteophytes on x-ray (Kellgren-Lawrence grade of 2-4)
- •Age ≥ 40 and ≤ 80 years.
- •Moderate to severe knee pain
- •Reduced joint space width at the medial part of the knee compared to the lateral part under x-ray examination. If standing is not feasible, the same supine position must be used consistently for follow-up.
- •A minimal pain score of 5 measured by both NRS and VAS when walking last week.
- •Knee pain on most days (no less than 15 days) in the 4 weeks before screening
- •Patients have experienced that NSAID or opioid pain medication failed to control knee pain in the last year.
- •Patients have experienced that a single intra-articular injection of medicines, such as steroids, hyaluronic acid, or platelet-rich plasma, failed to control the knee pain over 6 months.
- •Non-invasive treatments did not control the knee pain. Conservative and non-invasive treatment regimens may include any or all of the following: initial rest, muscle relaxants, massage, and oral medications, e.g., anti-inflammatory drugs, analgesics, narcotics/opioids.
- •The patients have taken supervised physical and rehabilitation therapy, such as daily walking routines, therapeutic exercises, sonication, heat/cold therapy, and electric stimulation for knee pain control within the last year.
排除标准
- •Patients who have taken knee, distal femur, or proximal tibia surgery.
- •Patients who took an intra-articular injection of medicine, such as steroids, hyaluronic acid, or platelet-rich plasma, in the last 3 months.
- •Reduced joint space width at the lateral part of the knee compared to the medial part under x-ray examination.
- •Patients who have severe varus deformity and tibiofemoral alignments are larger than 20 degrees.
- •Patients who cannot cooperate with the two-year follow-up.
- •Patients who have had tumor, infection, or trauma at the time of recruitment.
- •Patients with abnormal blood routine test, such as severe anemia, leukemia, sepsis, platelet dysfunction, or other blood-related diseases.
- •Patients who cannot agree to the withdrawal of non-steroid anti-inflammatory drugs (NSAIDs) or opioids during the trial period.
- •Patients who cannot cooperate with blood drawing.
- •The body mass index (BMI) value of the patient is higher than
- •Female subjects who are pregnant, breastfeeding, planning to become pregnant, or unable to cooperate in contraception during the trial.
- •Subjects with a history of neurocognitive disorders, or those who have sought neurological consultation due to suspected dementia or memory decline
- •History of post-traumatic osteoarthritis.
- •History of rheumatoid arthritis, gouty arthritis, spontaneous osteonecrosis of the knee (SONK), or hemophilia.
- •Employees or family members of the PI and co-PI.
研究组 & 干预措施
High-dose PCP-PBMCs injection
Participants received PCP-PBMCs injection of 100-200 million PBMCs injection on day 1.
干预措施: High-dose PCP-PBMCs injection (Biological)
Low-dose PCP-PBMCs injection
Participants received PCP-PBMCs injection of 20-60 million PBMCs injection on day 1.
干预措施: Low-dose PCP-PBMCs injection (Biological)
Solu-Medrol
Participants received solu-medrol solution as matching-drug on day 1.
干预措施: Solu-Medrol (Drug)
结局指标
主要结局
Mean Reduction in Numeric Rating Scale (NRS) Score
时间窗: Up to 52 weeks
Mean reduction in NRS for OA pain from baseline to post-treatment. NRS is a 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable) with a minimal clinically important difference (MCID) of 2.0. Participants are required to indicate a score on the scale that corresponds to their perceived level of pain in their knees.
Changes in scores on the Knee injury and Osteoarthritis Outcome Score (KOOS)
时间窗: Up to 52 weeks
The KOOS evaluates symptoms and function in subjects with knee OA, holding five separately scored subscales: Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). The KOOS ranges from 0 to 100, with lower scores indicating worse pain.
Mean Change in Numeric Rating Scale (NRS) Score
时间窗: Up to 52 weeks
Mean change in NRS for OA pain from baseline to post-treatment. NRS is a 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable) with a minimal clinically important difference (MCID) of 2.0. Participants are required to indicate a score on the scale that corresponds to their perceived level of pain in their knees.
次要结局
- Mean Reduction in Numeric Rating Scale (NRS) Score(Up to 104 weeks)
- Changes in scores on the Knee injury and Osteoarthritis Outcome Score (KOOS)(Up to 104 weeks)
- Mean Reduction in the Visual Analog Scale (VAS)(Up to 104 weeks)
- Changes in scores on the Intermittent and Constant Osteoarthritis Pain (ICOAP) questionnaire(Up to 104 weeks)
- Changes in scores on the Assessment of Quality of Life 8 Dimension (AQoL-8D)(Up to 104 weeks)
- Change in Minimum Joint Space Width (JSW)(Up to 104 weeks)
- Mean Change in Numeric Rating Scale (NRS) Score(Up to 104 weeks)
- Mean Change in the Visual Analog Scale (VAS)(Up to 104 weeks)