Recruiting

Marrow Cellution vs. Traditional BMA

Sponsor:

Ohio State University

Code:

NCT06388993

Conditions

Hip Arthropathy

Avascular Necrosis of Bone

Subchondral Cysts

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

Bone Marrow Collection

Study Details

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

Study ID

NCT06388993

Start date

Mar 25, 2024

Status verified date

Mar, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2025

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

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 Design

Enrollment

6 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Bone Marrow Collection

Comparing the two collection systems for bone marrow aspirate

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

Jameson Crane Sports Medicine Institute

Recruiting

Columbus, Ohio, United States, 43202

Contacts

Principal Investigator:

William K Vasileff, MD

More Information

Sponsor

Ohio State University

Last update posted

Apr 1, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Ohio State University on 2026-04-01.