Marrow Cellution™ vs. Traditional BMA Harvest Project

NCT06388993 | Recruiting FDA Device

• 1 other identifier: 2023H0351
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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,

Conditions

Hip Arthropathy; Avascular Necrosis of Bone; Subchondral Cysts

Outcome Measures

Primary Outcomes (1)

• Assess overall number of stem cells collected from each aspiration method

  Compare total amount of stem cells collected from each sample

  6 Months

Secondary Outcomes (2)

• 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

Study Arms (1)

Bilateral Hip Bone Marrow Collection

EXPERIMENTAL

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

Interventions

Bone Marrow Collection DEVICE

Comparing the two collection systems for bone marrow aspirate

Bilateral Hip Bone Marrow Collection

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

Jameson Crane Sports Medicine Institute

Columbus, Ohio, 43202, United States

RECRUITING

MeSH Terms

Conditions

Osteonecrosis; Bone Cysts

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cysts; Neoplasms

Study Officials

• William K Vasileff, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Keller

CONTACT

614-293-2410; michael.keller@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Orthopedics

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: April 29, 2024
• Study Start: March 25, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)