Marrow Cellution™ vs. Traditional BMA Harvest Project

Официальное название

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

Обзор

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,

Подробное описание

l

Вмешательства

• Устройство Bone Marrow Collection
  Comparing the two collection systems for bone marrow aspirate

Первичные конечные точки

• Assess overall number of stem cells collected from each aspiration method [Срок оценки: 6 Months]

Вторичные конечные точки (2)

• Assess overall number of cytokines collected from each aspiration method [Срок оценки: 6 Months]
• Assess overall number of growth factors collected from each aspiration method [Срок оценки: 6 Months]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Jameson Crane Sports Medicine Institute — Columbus

Идентификаторы

NCT: NCT06388993 · 2023H0351

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗