A Phase II, Randomized, Parallel-Group Study to Investigate the Combined Use of PRP with Lipoaspirate And/or Bone Marrow Aspirate in Osteoarthritis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Changes from baseline through to end of study for the Visual Analogue Scale (VAS).
研究概览
简要总结
To demonstrate the efficacy of the combined use of platelet-rich plasma (PRP) with lipoaspirate and/or bone marrow aspirate in osteoarthritis of major joints, and to compare the outcomes achieved using three combinations: PRP plus lipoaspirate, PRP plus bone marrow aspirate, and PRP plus both lipoaspirate and bone marrow aspirate.
详细描述
The purpose of this study is to demonstrate the efficacy of the combined use of platelet-rich plasma (PRP) with lipoaspirate and/or bone marrow aspirate in osteoarthritis of major joints, and to compare the outcomes achieved using three combinations: PRP plus lipoaspirate, PRP plus bone marrow aspirate, and PRP plus both lipoaspirate and bone marrow aspirate.
A total of 240 participants will be randomly assigned to one of three treatment groups: Group A will receive PRP plus lipoaspirate, Group B will receive PRP plus bone marrow aspirate, and Group C will receive tri-partite therapy of PRP + lipoaspirate + bone marrow aspirate which allows for 80 in each group. The combination of biologic materials will be injected in to an arthritic joint.
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
- 19 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Capable of providing written informed consent and willing and able to adhere to all protocol requirements.
- •Male or female at least 19 years of age at the time of providing written informed consent.
- •Evidence of OsteoArthritis in a major joint requires recent (within one year) imaging, either by x-ray or MRI. Kellgren & Lawrence Grades 1-3 are accepted for participation.
排除标准
- •Arthroscopic surgery to the treatment joint within 12 months
- •Cortisone or HA injection within the last 3 months prior to stem cell injection
- •Inability to hold antiplatelet therapy according to treating provider prior to procedure
- •Kellgren & Lawrence Grade 4 Osteoarthritis
- •Participants with a platelet count less than 100 x 109
- •Participants with a Hemoglobin less than 100 g/L
- •Participants who have an active Infection with fever and/or elevated white blood cell (WBC) count
- •Participants with an active Cancer diagnosis.
- •Participants with autoimmune disorders including rheumatoid arthritis and lupus.
- •Women who are pregnant will be excluded due to the possibility of fetal harm associated with x-rays. Should a participant become pregnant during the study, she will be withdrawn from further treatment and imaging, but can participate in symptom follow-up. Female participants of childbearing potential will be counseled at screening about contraception and encouraged to use birth control for the duration of the study.
- •Participants with allergies to lidocaine, heparin, or epinephrine.
研究组 & 干预措施
Group A - PRP plus Lipoaspirate
Equal proportions of PRP plus micronized adipose tissue (lipoaspirate). Total Volume varies by joint.
干预措施: Autologous cell therapy (Biological)
Group B - PRP plus Bone Marrow Aspirate
Equal proportions of PRP plus bone marrow aspirate. Total Volume varies by joint.
干预措施: Autologous cell therapy (Biological)
Group C - PRP plus Lipoaspirate plus Bone Marrow Aspirate
Equal proportions of PRP plus micronized adipose tissue (lipoaspirate) plus bone marrow aspirate. Total Volume varies by joint.
干预措施: Autologous cell therapy (Biological)
结局指标
主要结局
Changes from baseline through to end of study for the Visual Analogue Scale (VAS).
时间窗: The VAS will be measured at baseline (week 1) through to the end of the study (week 104). To test for improvement, comparisons to baseline will be made at 6 months (week 26,) 12 months (week 52) and 24 months (week 104).
Visual analogue scales (VAS) are psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients and use this to achieve a rapid (statistically measurable and reproducible) classification of symptom severity. This scale measures ranges from 0 whereby the patient has no discomfort or distress to 10 where the patient has agonizing pain and is in unbearable distress. (0 - None, 1, 2 - Annoying, 3, 4 - Uncomfortable, 5, 6 - Dreadful, 7, 8 - Horrible, 9, 10 - Agonizing). The patient can place an x anywhere on the continuum between 0-10 based on their level of discomfort . We will then measure the scale using a ruler to the tenth of a point. The VAS scale will be completed at each visits 2-7. Comparisons will be made from baseline to end of study to determine the overall improvement.
Changes from baseline through to the end of study for the Short Form 12 item version 2 (SF12-v2)
时间窗: The SF12-v2 will be measured at baseline (week 1) through to the end of the study (week 104). To test for improvement, comparisons to baseline will be made at 6 months (week 26,) 12 months (week 52) and 24 months (week 104).
The SF-12 is a validated and widely used twelve question health survey used to assess health related quality of life from the patients perspective. The SF12-v2 items are scored so that a higher score means a better health. For example, the functioning items are scored so that a higher score represents better functioning, whereby pain items scored so that a high score indicates freedom from pain. The SF12-v2 will be completed at each visits 2-7. Comparisons will be made from baseline to end of study to determine the overall improvement.
次要结局
- Comparison to evaluate the degree of change among treatment arms (Group A, Group B and Group C) from baseline visit through to end of study.(The VAS will be measured at baseline (week 1) through to the end of the study (week 104). To test for improvement, comparisons to baseline will be made at 6 months (week 26,) 12 months (week 52) and 24 months (week 104).)
- Comparison to evaluate the degree of change among treatment arms (Group A, Group B and Group C) baseline visit through to end of study.(The SF12-v2 will be measured at baseline (week 1) through to the end of the study (week 104). To test for improvement, comparisons to baseline will be made at 6 months (week 26,) 12 months (week 52) and 24 months (week 104).)
- Flow cytometry(Visit 2 (Week 1) Samples are collected at visit 2 (week 1) and sent away for analysis by a university. The results will be received from the university prior to end for overall data analysis.)
研究者
Dr. Grant M. Pagdin
Qualified Investigator
Pagdin Health