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Recruiting

NCT Number: NCT06388993

Marrow Cellution™ vs. Traditional BMA Harvest Project

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,

Recruiting

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jameson Crane Sports Medicine Institute

Columbus, Ohio, 43202, United States

Location status: Recruiting

Location contact

Karen Persons

CONTACT

[email protected]

Michael Keller

CONTACT

[email protected]

614-293-2410

William K Vasileff, MD

PRINCIPAL_INVESTIGATOR

About this study

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Bone Marrow Collection

Device

Comparing the two collection systems for bone marrow aspirate

Primary outcomes

  1. Assess overall number of stem cells collected from each aspiration method

    Time frame: 6 Months

    Compare total amount of stem cells collected from each sample

Secondary outcomes

  1. Assess overall number of cytokines collected from each aspiration method

    Time frame: 6 Months

    Compare total amount of cytokines collected from each samples

  2. Assess overall number of growth factors collected from each aspiration method

    Time frame: 6 Months

    Compare total amount of growth factors collected from each samples

Study contacts

Contact information is provided by the study sponsor or research team.

Michael Keller

CONTACT

[email protected]

614-293-2410

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Apr 29, 2024
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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