Marrow Cellution™ vs. Traditional BMA Harvest Project

Hip Arthropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06388993
• Other study ID #: 2023H0351
• Status: Recruiting
• Phase: N/A
• Start date: March 25, 2024
• Est. completion date: March 31, 2025

Study information

• Verified date: April 2024
• Source: Ohio State University
• Contact: Michael Keller
• Phone: 614-293-2410
• Email: michael.keller[@]osumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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,

Description:

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Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6
• Est. completion date: March 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Avascular Necrosis of Bone
• Bone Cysts
• Hip Arthropathy
• Necrosis
• Osteonecrosis
• Subchondral Cysts

Intervention

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

Locations

Country	Name	City	State
United States	Jameson Crane Sports Medicine Institute	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess overall number of stem cells collected from each aspiration method	Compare total amount of stem cells collected from each sample	6 Months
Secondary	Assess overall number of cytokines collected from each aspiration method	Compare total amount of cytokines collected from each samples	6 Months
Secondary	Assess overall number of growth factors collected from each aspiration method	Compare total amount of growth factors collected from each samples	6 Months