Safety and Clinical Effectiveness of A3 SVF in Osteoarthritis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Pain and Inflammation - WOMAC scores, comprehensive inflammation blood panel
研究概览
简要总结
To purpose of this study is to determine if treatment with SVF (Stromal Vascular Fraction) has an effect on pain and inflammation associated with Osteoarthritis.
详细描述
This is a prospective non-randomized, clinical study of 30 patients to determine safety and treatment potential of A3(Adult Autologous Adipose) SVF for the pain and inflammation associated with Osteoarthritis.
Patients will be treated for Osteoarthritis due to degeneration or chronic injury. They will be given autologous SVF extract derived by the A3 method mixed with activated platelets from a PRP(platelet rich plasma) preparation as direct injections to the effected joints. Outcomes will be tracked with WOMAC (Western Ontario and McMaster Universities Arthritis Index), AUSCAN(Australian Hand Osteoarthritis Index) scores, and a general blood panel in order to evaluate systemic effects.
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
- 否
入选标准
- •Patients with indication of Osteoarthritis. Can be from degeneration or chronic injury.
- •Patients range from 15-90 years of age.
- •Female patients not pregnant or lactating.
- •Patients with a history of or current corticosteroid therapy will only be eligible if use is suspended from 1 month prior to cell therapy.
- •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 blood coagulation activity, PT(INR) < 1.5, APTT <1.5×control.
排除标准
- •Diagnosis of cancer within 5 years prior to screening, except for cutaneous basal cell or squamous cell cancer resolved by excision.
- •Signs and symptoms of clinically significant cardiac disease.
- •Diagnosis of a transient ischemic attack in the 6 months prior to screening,
- •Known allergy to anesthetic or any other components of study.
- •Patients infected with hepatitis B, C or HIV.
- •Patients with Body Mass Index (BMI) > 39kg/m2 .
- •Any other cardiovascular illness that in the opinion of the investigator would render a patient unsuitable to participate in the study.
结局指标
主要结局
Pain and Inflammation - WOMAC scores, comprehensive inflammation blood panel
时间窗: one year
次要结局
- Pain and Mobility Assessment(one year)
研究者
barbara krutchkoff
Dr John Huh, Los Angeles
Institute of Regenerative and Cellular Medicine