ClinicalTrials.gg
RecruitingNCT06388993Updated Apr 1, 2026

Marrow Cellution™ vs. Traditional BMA Harvest Project

An interventional study of Bone Marrow Collection in Hip Arthropathy, Avascular Necrosis of Bone and Subchondral Cysts, sponsored by Ohio State University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-04-01.

Sponsored by Ohio State University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Mar 2024; still recruiting 2 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
18 Years to 50 Years
Sex
All
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Study 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,

Read the detailed description

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02

Conditions studied

  • Hip Arthropathy
  • Avascular Necrosis of Bone
  • Subchondral Cysts
03

In context

Osteonecrosis

286 studies on the registry are indexed under Osteonecrosis; 45 are open to participants now.

This study's planned enrollment of 6 is below the median of 68 across 151 interventional studies indexed under Osteonecrosis.

Browse Osteonecrosis studies →

Lead sponsor

Ohio State University is the lead sponsor of 663 studies on the registry; 148 are open to participants now.

Of its 67 completed or terminated interventional studies of FDA-regulated products, 49 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (estimated)

Study 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.

    Device: Bone Marrow Collection

Interventions

  • DeviceBone Marrow Collection

    Comparing the two collection systems for bone marrow aspirate

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What researchers measure

Primary outcomes

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

    Compare total amount of stem cells collected from each sample

    Time frame: 6 Months

Secondary outcomes

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

    Compare total amount of cytokines collected from each samples

    Time frame: 6 Months

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

    Compare total amount of growth factors collected from each samples

    Time frame: 6 Months

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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No — No IPD will be shared.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2024 to primary completion in Dec 2025, 21 months.

Of 45 interventional studies with no phase under Osteonecrosis, half reached primary completion within 52 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 91. This study's 21 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 24, 2024
First posted
Apr 29, 2024
StartActual
Mar 25, 2024
Primary completionActual
Dec 31, 2025
CompletionEst.
Dec 31, 2026
Last update
Apr 1, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06388993
Responsible party
William Vasileff (Associate Professor of Clinical Orthopedics, Ohio State University) — Principal investigator
First posted
Apr 29, 2024
Start date
Mar 25, 2024
Primary completion
Dec 31, 2025
Completion
Dec 31, 2026 (estimated)
Last update
Apr 1, 2026

Study contacts

Michael Keller
Contact
michael.keller@osumc.edu
614-293-2410
William K Vasileff, MD
principal investigator · Ohio State University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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