Application of Autologous Stem Cells From Adipose Tissue in the Regeneration of Knee Joint Cartilage
试验速览
- 阶段
- 4 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
研究概览
简要总结
This randomized, controlled clinical trial will evaluate the safety and effectiveness of autologous adipose-derived stromal vascular fraction (SVF) therapy in patients with knee osteoarthritis (OA) grades II-IV, compared with standard chondroprotective (CP) treatment. The study will enroll male and female patients and follow them for 12 months, assessing pain (VAS), function (WOMAC, KOOS, SF-36), radiologic progression, and safety (adverse events). The trial aims to determine whether SVF therapy provides superior clinical outcomes and to inform evidence-based recommendations for OA management in the Serbian population.
详细描述
Knee osteoarthritis (OA) is a progressive degenerative joint disorder characterized by cartilage loss, subchondral bone remodeling, synovial inflammation, and joint pain. It is a leading cause of disability worldwide, particularly affecting weight-bearing joints such as the knee. The pathological process involves a combination of mechanical stress, inflammatory cytokine activity, and abnormal tissue remodeling, leading to progressive cartilage degradation and functional impairment. OA is increasingly recognized as a biologically active disease rather than a simple "wear-and-tear" condition, with complex interactions among chondrocytes, synoviocytes, immune cells, and extracellular matrix components.
Current non-surgical therapies, including analgesics, physiotherapy, and chondroprotective agents, primarily address symptom control and functional preservation, without altering the underlying degenerative process. Surgical interventions, such as osteotomy or total knee arthroplasty, are reserved for advanced disease but are associated with risks and limited applicability in younger or active patients. These limitations have prompted the exploration of regenerative medicine approaches that aim to restore joint homeostasis and promote cartilage repair.
Autologous adipose-derived stromal vascular fraction (SVF) has emerged as a promising regenerative therapy for knee OA. SVF is a heterogeneous cell population derived from adipose tissue, comprising mesenchymal stem cells (MSCs), pericytes, endothelial progenitors, and other stromal cells. These cells possess anti-inflammatory, immunomodulatory, and trophic properties that can support tissue repair both directly and indirectly. SVF may contribute to cartilage regeneration through differentiation of MSCs into chondrocytes, secretion of growth factors and cytokines that stimulate resident chondrocytes, modulation of synovial inflammation, and promotion of angiogenesis in the subchondral bone. Compared to bone marrow-derived MSCs, adipose tissue provides a more abundant and easily accessible source of regenerative cells with minimal donor site morbidity.
Preclinical studies and early clinical trials have demonstrated that intra-articular injection of adipose-derived SVF is feasible, safe, and associated with improvements in pain, function, and cartilage quality. However, there is a paucity of controlled clinical data directly comparing SVF therapy with standard chondroprotective interventions, particularly in the Serbian population. The present study is designed to address this gap by systematically evaluating the clinical efficacy, safety, and regenerative potential of SVF in patients with moderate to severe knee OA.
This trial will employ rigorous, standardized methodologies for SVF isolation and administration, using a closed mechanical system to obtain a highly viable and potent cell population. By combining clinical assessments with imaging-based evaluation of cartilage repair, this study aims to generate comprehensive data on both symptomatic and structural outcomes. The results are expected to provide critical evidence to support the integration of SVF therapy into standard orthopedic practice, potentially offering a regenerative alternative for patients with degenerative knee disease.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (≥18 years).
- •Radiologically confirmed knee OA (grades II-IV, Kellgren-Lawrence scale).
- •KOOS pain score ≤ 60 points.
- •Symptomatic degenerative knee disease with at least 6 months of persistent pain.
- •No history of major knee trauma or prolonged immobilization (>10 days)
排除标准
- •Minors (<18 years).
- •Asymptomatic OA (KL grade 0-I).
- •Severe axial deformity (varus >10°, valgus >10°).
- •Current anticoagulant or antiplatelet therapy.
- •Intra-articular corticosteroid injection within the past 6 months.
- •History of major knee trauma or surgery.
研究组 & 干预措施
CP group
In this arm we will included patient swhich will be treated with Reviscon Re cross HA injection by MV Pharm
干预措施: CP (Drug)
SVF group
In this arm, we included patients which will be treated with intraarticular injection of SVF from fat pad
干预措施: stromal vascular fraction (SVF) (Biological)
结局指标
主要结局
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
时间窗: Baseline, 3 6 and 12 months post-treatment.
Description: The WOMAC is a validated self-administered questionnaire measuring pain, stiffness, and physical function in patients with knee osteoarthritis. Each subscale is scored, with higher scores indicating greater disability. Purpose: To assess changes in pain, joint stiffness, and functional impairment over time.
次要结局
- Knee Injury and Osteoarthritis Outcome Score (KOOS)(Baseline (pre-treatment) 3, 6 and 12 months post-intervention.)
- Lysholm Knee Scoring Scale(Timepoints: Baseline, 3, 6 and 12 months post-treatment.)
- Visual Analog Scale (VAS) for Pain(Baseline, 3,6 and 12 months post-treatment.)
- MRI-based Cartilage Evaluation (MOCART Score)(Baseline and 12 months post-treatment.)
- Short Form Health Survey (SF-36)(Baseline and 12 months post-treatment.)
- Documentation of Adverse Events(Throughout the 12-month follow-up.)
研究者
Sasa Karan
Sasa Karan, MD, Orthopedic surgeon and Traumatologist
Clinical Center of Vojvodina
