跳至主要内容
临床试验/NCT03014037
NCT03014037已完成不适用

Comparing Mesenchymal Stem Cell Counts in Unilateral vs. Bilateral Posterior Superior Iliac Spine Bone Marrow Aspiration

Emory University2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2017年9月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
35
试验地点
2
主要终点
Change Quality of Life assessed by the Emory Quality of Life (EQOL) Survey Score

研究概览

简要总结

Musculoskeletal conditions are common sources of pain. Specifically, osteoarthritis affects nearly 27 million people in the United States. This disease leads to the breakdown of the cartilage surfaces of the joints, which serve as the connection points between the bones of the body, causing a large amount of pain and disability in patients. Increasing the number of available treatment options for osteoarthritis is becoming increasingly more important as Americans continue to age. Using stem cells taken from bone marrow is one of the non-operative treatments that has been gaining popularity in the recent past. This study aims to clarify how this procedure should best be done by comparing stem cell concentrations and patient outcomes (short and long term) in patients who have stem cells taken from one area vs two (unilateral vs bilateral posterior superior iliac spine (PSIS) aspirations).

详细描述

Musculoskeletal conditions are common sources of pain. Specifically, osteoarthritis affects nearly 27 million people in the United States. This disease leads to the breakdown of the cartilage surfaces of the joints, which serve as the connection points between the bones of the body, causing a large amount of pain and disability in patients. Increasing the number of available treatment options for osteoarthritis is becoming increasingly more important as Americans continue to age. Using stem cells taken from bone marrow is one of the non-operative treatments that has been gaining popularity in the recent past. This study aims to clarify how this procedure should best be done by comparing stem cell concentrations and patient outcomes (short and long term) in patients who have stem cells taken from one area vs two (unilateral vs bilateral posterior superior iliac spine (PSIS) aspirations).

This research study involves the participant being randomly placed into one of two groups; one group will have cells taken from one hip, and the other will have cells taken from both hips. Both of these approaches are performed in clinics currently, and both are considered to be standard of care. All bone marrow collected for the purposes of this study will be obtained by the principal investigator while performing the standard procedure. In obtaining these sample the physicians will abide by the standard of care set forth for the Bone Marrow Aspiration Concentrate procedure.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Currently scheduled for a bone marrow aspirate concentration (BMAC) procedure
  • Cognitively able to give consent and complete the required questionnaires

排除标准

  • History of leukemia or lymphoma
  • History of any autoimmune disorders and disease
  • Currently taking immunosuppressive medications
  • Presence of an active or suspected infection, or an infection of the joint in question within the past 6 months
  • Vulnerable populations (pregnant women and breast-feeding women)
  • Cortisone injection into the affected joint within 6 weeks
  • Used NSAIDs within 1 week of the procedure
  • History of bleeding disorders or inflammatory joint disease
  • Surgical intervention on the affected or contralateral joint within 6 months of BMAC injection

结局指标

主要结局

Change Quality of Life assessed by the Emory Quality of Life (EQOL) Survey Score

时间窗: Pre-treatment, Follow Up (Up to One Year)

The EQOL survey measures five dimensions - mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant will be asked to answer questions regarding these measures and to indicate their current experience on a scale from 1 to 3; 1 being "no problem" and 3 being "most extreme problem". The answers to these question are put together to create a 5 digit composite score.This composite score can be indexed to a lookup table which produces a single summary score from 0 to 100. The lookup table we use is weighted and normalized to the United Stated general population.

Change in the Knee Injury and Osteoarthritis Outcome Score (KOOS)

时间窗: Pre-treatment, Follow Up (Up to One Year)

The KOOS questionnaire is an instrument to assess the patient's opinion about their osteoarthritis and associated problems. It consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. A total lower score indicates more problems.

次要结局

  • Capacity of Isolated Cells to Differentiate Down Cell Lineages(Post Cell Culture (Up to 21 Days))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kenneth Mautner

Associate Professor

Emory University

研究点 (2)

Loading locations...

相似试验