Effect of Implanting Allogenic Cytokines Derived From Human Amniotic Membrane (HAM) and Mesenchymal Stem Cells Derived From Human Umbilical Cord Wharton's Jelly (HUMCWJ) on Pain and Functioning of Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in pain during sit-to-stand over 3 months
研究概览
简要总结
The purpose of this study is to compare the pain, functioning and pain medication consumption of knee osteoarthritis (OA) patients who have allogenic cytokines derived from human amniotic membranes (HAM) and allogenic mesenchymal stem cells derived from human umbilical cord Wharton's Jelly (HUMCWJ) implanted into the affected knee with knee OA patients who self-select to be in a non-intervention control group.
详细描述
A total of 60 patients will be recruited from Scott Medical Health Center in Pittsburgh, PA. Inclusion criteria for the study are knee OA patients who are eligible for HAM and HUMCWJ therapy of their knee, no previous HAM or HUMCWJ therapy, between the ages of 50-85, independently residing in the community, no previously diagnosed cognitive decline or mental illness, and not taking pain medication more than once per week for a condition other than knee OA. Recruitment will be done in two parts as participants will self-select to participate in one of two study groups. All participants who elect to have the procedure done at the initial consultation, meet inclusion criteria, and agree to be in the study will be placed in Group 1. Participants who do not wish to have the procedure, meet inclusion and exclusion criteria, and agree to be in the study will be placed in Group 2. Those participants who are unsure about the procedure and need more time to decide will be contacted 2 weeks later and then group will be determined by their decision. All participants will be required to sign a written informed consent prior to data collection. Following written consent, all participants will undergo data collection (T0). At T0, participants will complete a demographic and medication use questionnaire, the Western Ontario and McMaster Universities Arthritis Index (WOMAC), knee survey, and be timed during a single trial of three functional tasks. Participants will also provide a pain rating while completing each of the functional tasks. Group 1 will then undergo HAMS injection to the OA affected knee immediately following the testing battery. Group 2 will delay the HAMS injection to the OA affected knee for at least 3 months or never receive the injection. All participants will complete T1 data collection approximately 4 weeks following completion of T0 data collection and T2 data collection approximately 3 months following completion of T0 data collection. The T1 and T2 data collections will use the same data collection procedures and questionnaires.
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
- 50 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •knee OA patients who are eligible for HAM and HUMCWJ therapy of their knee, no previous HAM or HUMCWJ therapy, between the ages of 50-85, independently residing in the community, no previously diagnosed cognitive decline or mental illness, and not taking pain medication more than once per week for a condition other than knee OA
排除标准
- •Allergy to or use of penicillin, streptomycin, emphotericin B or dimethylsulfoxide. DMSO allergies and any immunocompromised conditions will also be excluded
结局指标
主要结局
Change in pain during sit-to-stand over 3 months
时间窗: Baseline (T0), 4 weeks (T1), 3 months (T2)
Participants will perform as many sit-to-stand movements as they can in 30 seconds and then will rate pain
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) over 3 months
时间窗: Baseline (T0), 4 weeks (T1), 3 months (T2)
Change in pain during supine to upright over 3 months
时间窗: Baseline (T0), 4 weeks (T1), 3 months (T2)
Participants will perform a supine to upright movement as quickly as they can and then will rate pain
Change in pain during ascent/decent stairs over 3 months
时间窗: Baseline (T0), 4 weeks (T1), 3 months (T2)
Participants will ascend and decent 10 stairs as quickly as they can and then will rate pain
次要结局
未报告次要终点
研究者
Gary Hieronimus
Doctor of Chiropractic
Scott Medical Health Center
