Marrow Cellution™ vs. Traditional BMA Harvest Project

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

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,

Study Overview

• Status: Recruiting
• Conditions: Hip Arthropathy; Subchondral Cysts; Avascular Necrosis of Bone
• Intervention / Treatment: Device: Bone Marrow Collection

Detailed Description

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• Study Type: Interventional
• Enrollment (Estimated): 6
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael Keller; Phone Number: 614-293-2410; Email: michael.keller@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43202
      • Recruiting
      • Jameson Crane Sports Medicine Institute
      • Principal Investigator: William K Vasileff, MD
      • Contact: Michael Keller; Phone Number: 614-293-2410; Email: michael.keller@osumc.edu
      • Contact: Karen Persons; Email: andrea.persons@osumc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bilateral Hip Bone Marrow Collection; Collection of bone marrow aspirate from both hips. One collected using the Zimmer Biomet Biocue system and the other using the Marrow Cellution system.	Device: Bone Marrow Collection; Comparing the two collection systems for bone marrow aspirate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess overall number of stem cells collected from each aspiration method	Compare total amount of stem cells collected from each sample	6 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess overall number of cytokines collected from each aspiration method	Compare total amount of cytokines collected from each samples	6 Months
Assess overall number of growth factors collected from each aspiration method	Compare total amount of growth factors collected from each samples	6 Months

Collaborators and Investigators

• Sponsor: Ohio State University
• Investigators: Principal Investigator: William K Vasileff, MD, Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: April 24, 2024
• First Submitted That Met QC Criteria: April 24, 2024
• First Posted (Actual): April 29, 2024

Study Record Updates

• Last Update Posted (Actual): April 29, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Cysts; Musculoskeletal Diseases; Bone Diseases; Necrosis; Osteonecrosis; Bone Cysts
• Other Study ID Numbers: 2023H0351

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No IPD will be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes