Safety and Effectiveness of Autologous Regenerative Cell Therapy on Pain and Inflammation Associated With Osteoarthritis of the Shoulder
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 4,000
- 试验地点
- 1
- 主要终点
- Change is being assessed for the DASH Survey (Disabilities of the Arm, Shoulder, Hand
研究概览
简要总结
This is a prospective open-label clinical study of 50 patients to determine safety and treatment potential of autologous cell therapy for pain and inflammation associated with Osteoarthritis of the shoulder. Follow-up will consist of a larger sample including 4,000 patients.
详细描述
This is a prospective open-label clinical study of 50 patients to determine safety and treatment potential of autologous cell therapy for pain and inflammation associated with Osteoarthritis of the shoulder. Follow-up will consist of a larger sample including 4,000 patients.
Patients will be treated for Osteoarthritis (OA) of the shoulder due to degeneration or chronic injury. They will be treated with autologous Stromed obtained by the Adipose Ultrasonic Cell Recovery Unit (AUCRU) and Platelet Rich Plasma (PRP) processed by the RegenLab (RegenKit BCT-3) PRP product each as direct injections to the affected joints. Patient outcomes will be tracked with laboratory tests for inflammation markers, the DASH and SPADI questionnaires and a follow up MRI at various endpoints to 6 months. SF-36 forms (a quality of life measure) and numerical ratings scales (NRS) will also be used to assess safety and efficacy of treatment, as well as any reduction in patient medication and/or delay in pending shoulder planning/replacement therapy.
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
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with indication of Osteoarthritis. Can be from degeneration or chronic injury.
- •Patients range from 18-90 years of age.
- •Patients must be able to comply with treatment plan, laboratory tests and periodic interviews.
- •Patients with adequate renal function, Creatinine ≤ 1.5 mg/dl.
- •Patients with adequate cardiac and respiratory function.
- •Patients with adequate blood coagulation activity, PT(INR) < 1.5, APTT
- •Patients must have adequate immune system function, with no known immunodeficiency disease.
- •Greater than 6 months shoulder pain with the index side (left or right shoulder).
排除标准
- •Neoplastic cancer within 5 years prior to screening, except for cutaneous basal cell or squamous cell cancer resolved by excision
- •Presence of clinically significant acute or unstable cardiovascular, cerebrovascular (stroke)..
- •Diagnosis of a transient ischemic attack in the 6 months prior to screening.
- •Patients infected with hepatitis B, C or HIV.
- •Patients with Body Mass Index (BMI) > 40kg/m2
- •Presence of active infection.
- •Any other illness, psychiatric disorder, alcohol or chemical dependence that in the opinion of the investigator would render a patient unsuitable to participate in the study.
- •Conditions/therapies/factors which could confound or interfere with the evaluation of pain/mobility including, but not limited to:
- •Treatments with strong opioid drugs in the previous 4 weeks for other pain rather than shoulder osteoarthritis
- •Corticosteroid injection at treatment site within 1 month
- •Consistent use of NSAIDs within 48 hours of procedure.
研究组 & 干预措施
StroMed + platelet rich plasma (PRP)
Because no enzymes or drugs are added with this mechanical process, the resulting (StroMed) cell concentrate still contains the extra-cellular matrix. In addition, the cells have not been altered by manipulation with enzymes or culturing. This autologous, cell concentrate is of minimal risk to the patient with no artificial ingredients added. Additional treatments with Platelet Rich Plasma processed by the RegenLab (RegenKit BCT-3) PRP product and by direct injection to affected joint.
干预措施: [StroMed + platelet rich plasma (PRP)] (Biological)
结局指标
主要结局
Change is being assessed for the DASH Survey (Disabilities of the Arm, Shoulder, Hand
时间窗: 0,2,6 months
Disabilities of the Arm, Shoulder, and Hand
次要结局
- Change is being assessed for the SF36 Survey (Short Form Health Survey)(0,2,6 Months)
- Change is being assessed for the NRS Survey (Numerical Rating Scale for Pain)(0,2,6 Months)
- Change is being assessed for the SPADI Survey (Shoulder Pain and Disability Index)(0,2,6 Months)
- Change is being assessed by MRI of afflicted joint(0 and (6 months optional))