Short-Term Changes in Knee Synovial Fluid Composition Following Intraarticular Implantation of Amniotic Tissue Allograft
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Knee Joint Chemical Profile
研究概览
简要总结
The investigators believe that amniotic tissue allografts may be an effective modality to treat osteoarthritis (OA) of the knee. One important mechanism of action may be stimulation of the synovial cells to increase production of endogenous hyaluronic acid (HA). A second mechanism may be the increase in the anabolic factors and a decrease in degenerative factors in the joint. The Investigators propose to quantify the concentration of HA and selected anabolic and degradative factors in synovial fluid aspirate pre and post implantation. While the treatment provided is designed to provide pain relief for symptoms, the purpose of this study is to learn more information about the impact of amniotic tissue allografts on inflammatory markers and growth factors in the knee joint.
详细描述
The investigators believe that amniotic tissue allografts may be an effective modality to treat osteoarthritis (OA) of the knee. One important mechanism of action may be stimulation of the synovial cells to increase production of endogenous hyaluronic acid (HA). A second mechanism may be the increase in the anabolic factors and a decrease in degenerative factors in the joint. The Investigators propose to quantify the concentration of HA and selected anabolic and degradative factors in synovial fluid aspirate pre and post implantation. While the treatment provided is designed to provide pain relief for symptoms, the purpose of this study is to learn more information about the impact of amniotic tissue allografts on inflammatory markers and growth factors in the knee joint.
The purpose of this study is to determine the changes in the composition of synovial fluid resulting from implantation of amniotic tissue allograft in the knee.
This study will characterize the chemical profile of painful osteoarthritic joints and the influence of various injections containing cells and/or growth factors on that chemical profile. The addition of amniotic tissue allograft to HA injections may be an, effective treatment for people with knee pain resulting from OA and furthermore may lead to customization and/or the identification of the most efficacious combination of joint injections.
Prior to any study-related treatment, participants will undergo an Institutional Review Board (IRB)-approved informed consent process for aspiration of synovial fluid, followed by a randomized injection of either A) saline only, B) hyaluronic acid, C) amnionic allograft, or D) hyaluronic acid plus amnionic allograft, with a second aspiration performed 1 week after injection. Synovial fluid samples from 88 participants indicated for amniotic tissue implantation will be analyzed in vitro to determine the cellular and biochemical characterization of the fluid obtained.
The aim of this study is to determine the changes in composition of synovial fluid resulting from implantation of amniotic tissue allograft in the knee. There is always a possibility that the insertion of a needle may in itself result in a change in the composition of synovial fluid and therefore to increase the strength of the study control arm (placebo) is necessary. The placebo controlled group is justified to provide evidence that the standard of care and research treatments are safe and efficacious.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Patients age 18 and over
- •Previous diagnosis of knee OA,
- •Kellgren-Lawrence grade of 2 - 4
- •Minimum Visual Analogue Scale (VAS) pain score of 3 on a scale of 0 - 10 where 0 is no pain and 10 is the highest level of pain
- •Can give written informed consent
排除标准
- •Receipt of HA, Platelet Rich Plasma (PRP) or amniotic cell injections in the previous 6 months
- •Recent history of surgery to the same joint in the previous 3 months
- •A clinical diagnosis of inflammatory arthritis made by history, examination or serology
- •An active or latent infection of the affected knee joint or any other systemic infection currently under treatment or treated within the previous 3 months
- •A history of chronic alcohol or drug abuse during the six months prior to the study
- •Clinically documented acute or unstable concomitant disease, other than the condition to be treated in this study that might be a confounding reason for the presence of pathogens (i.e. renal, hepatic, cardiac, endocrine, hematologic, autoimmune, metabolic bone, crystal deposition, severe degenerative joint, neoplastic diseases)
- •Systemic or intra-articular administration, within twenty days prior to the procedure, of any type of corticosteroids, antineoplastic, immune stimulating or immunosuppressive agents
- •Participation in any other investigational drug or device trial during the 30 days prior to screening visit or who will receive such a drug or device during the course of this study
- •Pregnant females
- •Subject is unable to understand verbal and/or written English
研究组 & 干预措施
Saline
The investigators aspirate 1-2ml of Synovial Fluid from the knee joint prior to administering a series of four injections (2.5ml, 2.5ml, 2.5ml and 1ml of Saline) comprising a total volume of 8.5ml fluid during one procedure.
干预措施: Saline (Drug)
Hyaluronic Acid & Saline
The investigators aspirate 1-2ml of Synovial Fluid from the knee joint prior to administering a series of four injections (2.5ml, 2.5ml, 2.5ml of Hyaluronic Acid and 1ml Saline) comprising a total of 8.5mL fluid during one procedure.
干预措施: Hyaluronic Acid (Device)
Hyaluronic Acid & Saline
The investigators aspirate 1-2ml of Synovial Fluid from the knee joint prior to administering a series of four injections (2.5ml, 2.5ml, 2.5ml of Hyaluronic Acid and 1ml Saline) comprising a total of 8.5mL fluid during one procedure.
干预措施: Saline (Drug)
Amniotic Tissue & Saline
The investigators aspirate 1-2ml of Synovial Fluid from the knee joint prior to administering a series of four injections (2.5ml, 2.5ml, 2.5ml of Saline and 1ml Amniotic Tissue Allograft) comprising a total of 8.5mL fluid during one procedure.
干预措施: Amniotic Tissue Allograft (Device)
Amniotic Tissue & Hyaluronic Acid
The investigators aspirate 1-2ml of Synovial Fluid from the knee joint prior to administering a series of four injections (2.5ml, 2.5ml, 2.5ml of Hyaluronic Acid and 1ml Amniotic Tissue Allograft) comprising a total of 8.5mL fluid during one procedure.
干预措施: Hyaluronic Acid (Device)
Amniotic Tissue & Hyaluronic Acid
The investigators aspirate 1-2ml of Synovial Fluid from the knee joint prior to administering a series of four injections (2.5ml, 2.5ml, 2.5ml of Hyaluronic Acid and 1ml Amniotic Tissue Allograft) comprising a total of 8.5mL fluid during one procedure.
干预措施: Amniotic Tissue Allograft (Device)
结局指标
主要结局
Knee Joint Chemical Profile
时间窗: 1 week
Evaluation of ELISA assay on synovial fluid aspirated pre and post study injection to ascertain the chemical profile of the joint for specific targets which include hyaluronic acid concentration, protein content and for increased levels of the following anabolic factors,IL1ra, TMP1, TMP2, HA, and IGF1 as well as decreased levels of the following degradative factors, IL-1, TNF-alpha, IL-10, MMP-2, MMP-9, TGF-beta5.
次要结局
- Function(1 week)
- VAS Pain scale(1 week)