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临床试验/CTRI/2024/10/074922
CTRI/2024/10/074922招募中2 期

Evaluating The Efficacy Of Intra-articular Bone Marrow Aspirate Concentrate Injection vs Steroid Injections For Pain And Function Improvement In Knee Osteoarthritis:A Short-Term Comparative Analysis

JIPMER IMRF1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2024年10月10日最近更新:

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
32
试验地点
1
主要终点
To assess the effectiveness of bone marrow aspirate concentrate injections compared to triamcinolone (corticosteroid) in improving short term clinical outcomes related to pain and function in patients with knee osteoarthritis

研究概览

简要总结

Background :Osteoarthritis (OA) is a chronic progressive degenerative disorder consisting of degeneration and loss of articular cartilage with accompanying synovitis, subchondral bone remodelling, and osteophyte formation . It constitutes a major cause of disability with pain, stiffness, resulting in severe functional limitations .

Although OA is a process of articular cartilage “wear and tear”, its changes are biochemically mediated , through an imbalance between intra-articular anabolic and catabolic cytokines . This results in cartilage loss, synovial inflammation and eventually leads to mechanical and biological dysfunction of the joint .

The articular cartilage due to its avascular nature and the limited self-renewal capacity of chondrocytes has remarkably poorer regenerative ability than other tissues .

Rationale :Current treatments for early phase of degenerative arthritis focus on relieving inflammation and pain , but have no effect on the natural progression of the disease because it does not improve the biochemical environment (homeostasis) of the joint.

Conservative treatments including medications such as non-steroidal anti-inflammatory drugs (NSAIDs) and steroids as well as supplements including glucosamine, chondroitin sulphate, omega-3 fatty acids , cannot alter the natural history of the disease.Steroids focus on relieving inflammation and pain

Costly total knee arthroplasty (TKA) then follows when other treatment options have been exhausted , however patients experience a higher risk of death from mental and inflammatory musculoskeletal diseases, with a serious adverse event rate of 5.6% and a 0.2% mortality rate .

Novelty:Recently, extraction of the mesenchymal stem cells (MSCs) obtained from autologous bone marrow (BMA) followed by concentration was introduced represents the next generation of injectable intra-articular orthobiologic therapy for patients with cartilage disease .

MSCs are multipotent cells that exhibit strong self-renewal abilities, combined with a differentiation capacity to form chondrocytes, adipocytes, and osteocytes . These cells also have very important local paracrine affects to alter their local microenvironment to conditions favourable for regeneration and repair .

BMAC represents the safest and most feasible source of MSCs. Intra-articular application has resulted in pain reduction, functional improvement and/or tissue regeneration . BMAC is obtained through density gradient centrifugation of bone marrow aspirate (BMA) typically aspirated from the iliac crest . BMAC has been shown to provide elevated levels of hematopoietic stem cells (HSCs), MSCs, platelets, chemokines and cytokines including PDGF and TGF-β .These growth factors (GFs) are not only contained within the alpha granules of platelets, but they are also secreted by MSCs and can induce chondrogenesis of MSCs . GFs also initiate stem cell migration to the injury site and provide adhesion sites for the migrating stem cells . Moreover BMAC possesses in general, anti-inflammatory, angiogenic trophic and immunomodulatory properties that can potentially have anabolic and anti-inflammatory effects enhancing cartilage repair .There are only very few studies comparing steroids with BMAC.

To date, there have been several studies that have looked at BMAC for the treatment of osteoarthritis, with conflicting results secondary to the differences and/or inconsistencies in methodologies used throughout the studies . Therefore, the role of BMAC in osteoarthritis is not yet been established

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
40.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Age ranging from 40 to 75 years Osteoarthritis of medial or lateral compartment [1-2 -3grade according to Kellgren Lawrence score] Failure of atleast 6 months of conservative management ] Bilateral knee osteoarthritis.

排除标准

  • 未提供

结局指标

主要结局

To assess the effectiveness of bone marrow aspirate concentrate injections compared to triamcinolone (corticosteroid) in improving short term clinical outcomes related to pain and function in patients with knee osteoarthritis

时间窗: Followup period for 3 months

次要结局

  • No secondary objective(Not applicable)

研究者

发起方
JIPMER IMRF
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr.Prabu.M

JIPMER

研究点 (1)

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