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临床试验/NCT06388993
NCT06388993招募中不适用

Comparison of the Constituents of Bone Marrow Aspirate and Autologous Protein Solution Collected with a Traditional and a Novel System

Ohio State University2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2024年3月25日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
6
试验地点
2
主要终点
Assess overall number of stem cells collected from each aspiration method

研究概览

简要总结

Six patients with diagnosed bone loss of the hip who have consented to minimally invasive repair will be approached to participate in the study. Participants will have the liquid portion of bone marrow collected using the Zimmer Biomet Biocue system, which is the standard system used by physicians at The Ohio State University, and the novel Marrow Cellutions system™. Bone marrow liquid will be collected from the surgical hip using the Zimmer Biomet Biocue system, and the Marrow Cellutions system™ will be used to collect bone marrow liquid from the non-surgical hip. Following collection, the bone marrow liquid will be processed using the respective systems to concentrate the cells and molecules found in the bone marrow liquid. As part of the standard of care for this arthroscopic procedure, concentrated bone marrow liquid processed using the Zimmer Biomet Biocue system will be delivered to the surgical site as an adjunct to promote healing. Concentrated bone marrow liquid prepared with the Zimmer Biomet Biocue system is given as part of the standard of care for patients undergoing minimally invasive treatment for bone loss of the hip; therefore, the target population for this study are individuals between the ages of 18-50 years with confirmed bone loss of the hip who have consented to minimally invasive repair. In addition to the concentrated bone marrow liquid prepared using the Zimmer Biomet Biocue system, patients will also have bone marrow liquid collected from the non-surgical hip using the Marrow Cellutions™ system. Only concentrated bone marrow liquid produced with the Zimmer Biomet Biocue system will be given to the patient. All concentrated bone marrow liquid produced with the Marrow Cellutions™ system will be sent to the laboratory for analysis. Additionally, white blood cells will be concentrated into an autologous protein solution (APS) using the Zimmer Biomet Plasmax system from blood collected using a routine blood draw. All protein solution produced will be sent to the laboratory for analysis. No protein solution will be given to the patient. As the bone marrow liquid collection using the Marrow Cellutions™ system and the blood draw to produce protein solution using the Zimmer Biomet Plasmax system are being performed for research,

详细描述

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研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • patients aged 18 - 50
  • patients undergoing hip arthroscopy for subchondral bone cysts and/or avascular necrosis

排除标准

  • patients with a history of hematologic issues including anemia and sickle cell anemia
  • patients with a history of leukemia, lymphoma, or other bone marrow related diseases
  • patients with diabetes
  • patients with a history of bone marrow aspirate

结局指标

主要结局

Assess overall number of stem cells collected from each aspiration method

时间窗: 6 Months

Compare total amount of stem cells collected from each sample

次要结局

  • Assess overall number of cytokines collected from each aspiration method(6 Months)
  • Assess overall number of growth factors collected from each aspiration method(6 Months)

研究者

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

William Vasileff

Associate Professor of Clinical Orthopedics

Ohio State University

研究点 (2)

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