Safety/Efficacy of Intra-articularly Administrated Autologous Adipose -Derived Stromal Vascular Fraction Cells in Treatment of Knee Osteoarthritis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- The number of patients with adverse events
研究概览
简要总结
Adipose-derived stromal vascular fraction cells (SVFs) include regenerative cell populations (hematopoietic cells, pericytes, endothelial cells and progenitors, stromal/stem cells) and thus are potentially important as new therapeutic tools for the repair and regeneration of acute and chronically damaged tissues.
The general objective of this study is to evaluate safety and clinical efficacy of a single intra-articular injection of freshly isolated auto-SVFs for the treatment of patients with knee osteoarthritis (OA). This study uses autologous adipose-derived SVFs, as therapeutic agent and intra-articular administration, as a mode of delivery. Expected clinical effects: a treatment reduces pain, increases function and reduces stiffness in the knees of osteoarthritic subjects.
详细描述
Subcutaneous human adipose tissue is an abundant and accessible cell source for applications in tissue engineering and regenerative medicine. Methods to extract stromal/stem cells from the waste products of abdominoplasty, cosmetic surgery, and liposuction are now well developed. Routinely, the adipose tissue is digested with collagenase or related enzymes to release a heterogeneous population of SVF cells. The SVF cells can be used directly or can be cultured in plastic ware to select and expand an adherent population known as adipose-derived stromal/stem cells.
Osteoarthritis is the most common joint disease that affects at least 20% of the world population. The disease usually begins at the age of 40 years. Radiographic signs of osteoarthritis are diagnosed in 50% of people aged 55 years and 80% - over 75 years. OA can cause severe pain and stiffness in the affected joints, thus reducing joint's functionality. Therefore a treatment that would reduce pain/stiffness and increase joint function would be of benefit to many people. Safety and feasibility of SVFs in OA patients have been shown in few clinical studies.
This trial is a prospective, controlled, non-randomized, non-blinded, interventional study to determine safety and efficacy of a single injection of freshly isolated autologous SVFs into the knees of osteoarthritic patients (Grade II-III). In experimental group the participants (n=16) will undergo a standard liposuction to harvest adipose tissue, then the adipose tissue will be processed to obtain the SVFs and patients will receive a single intra-articular injection of auto-SVFs into affected knees under the ultrasound navigation. In parallel control group the participants (n=11) will receive a single intra-articular injection of hyaluronic acid (Synocrom Forte 2%) under the ultrasound navigation. The safety of auto-SVFs injection will be evaluated by assessment of the frequency and nature of adverse events occurring during or immediately after the procedure, and up to the one year following treatment. Patients will be monitored during 1, 3, 6 and 12- month's visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40 to 85 Years (Adult, Senior)
- •Grade II or Grade III osteoarthritis of the knee joints using Kellgren-Lawrence grading scale (K-L Grade) as diagnosed using weight bearing X-ray and physician review, and/or MRI
- •Patients must have continued pain in the knee despite conservative therapies for at least 3 months
- •Patients must be able to tolerate all study procedures
- •Patients must be willing to voluntarily give written Informed Consent to participate in the study before any procedures are performed
- •Patients must be willing to be available for all baseline, treatment and follow-up examinations required by protocol
排除标准
- •Subjects with a BMI > 35
- •Subjects who have had an injection in either knee in the prior 4 weeks, including corticosteroids, drugs of hyaluronic acid or platelet rich plasma (PRP).
- •Subjects who have had surgery of either knee within 6 months prior to the screening visit
- •Subjects those are allergic to drugs for local anesthesia
- •Psychiatric disorders
- •Hepatic or renal dysfunctions
- •Hemodynamic or respiratory instability
- •HIV or uncontrolled bacterial, fungal, or viral infections
- •Autoimmune diseases (rheumatoid arthritis, lupus arthropathy, psoriatic arthritis, etc)
- •Pregnancy
- •Malignancy
- •Participation in other clinical trials
研究组 & 干预措施
Intra-articular auto-SVFs injection
The participants will undergo a standard liposuction to harvest adipose tissue. The adipose tissue will then be processed to obtain the SVFs.
This group of subjects (n=16) will receive a single injection of auto-SVFs into affected knees (3.0 mL cell suspension/joint).
干预措施: Intra-articular auto-SVFs injection (Procedure)
Intra-articular Hyaluronic Acid
This group of subjects (n=11) will receive a single injection of Synocrom Forte 2% into affected knees (1.0 mL/joint).
干预措施: Hyaluronic Acid (Drug)
结局指标
主要结局
The number of patients with adverse events
时间窗: up to 12 months after treatment
The safety of intra-articular injection of auto-SVFs will be evaluated by assessment of the frequency and nature of adverse events during or immediately after the procedure, and up to the 12-months following treatment
次要结局
- Change in Knee injury and Osteoarthritis Outcome Score (KOOS) at all follow-up visits(Baseline, 1, 3, 6 and 12 months after treatment)
- Change in Ultrasonography of the knee joints(Baseline, 3, 6 and 12 months after treatment)
- Change in pain score on the Visual Analogue Scale (VAS) at all follow-up visits(Baseline, 1, 3, 6 and 12 months after treatment)
研究者
Alexander A Ostanin
Head of Clinical Department
Russian Academy of Medical Sciences