Bone Marrow Collection for Hip Arthritis

Overseen By Michael Keller

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Disqualifiers: Hematologic issues, Leukemia, Diabetes, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

6 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Marrow Cellution™ for hip arthritis?

Research shows that bone marrow aspirate concentrate, which can be obtained using the Marrow Cellution system, is used in biologically enhanced surgical treatments and has been studied for conditions like knee osteoarthritis. This suggests potential benefits for hip arthritis as well, although more specific research is needed. ^{1 2 3 4 5}

Is bone marrow collection using the Marrow Cellution system safe for humans?

Bone marrow aspiration procedures, including those using the Marrow Cellution system, are generally considered safe, with rare adverse events such as bleeding reported in a small number of cases. ^{1 2 6 7 8}

How is the Marrow Cellution treatment for hip arthritis different from other treatments?

The Marrow Cellution treatment is unique because it uses a novel method to collect bone marrow cells without the need for centrifugation, which simplifies the process and reduces potential complications. This method targets cells from the inner bone surface and allows for lateral flow collection, making it less invasive and potentially more efficient than traditional methods that require multiple punctures and centrifugation. ^{1 2 3 5 6}

What is the purpose of this trial?

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,

Research Team

William K Vasileff, MD

Principal Investigator

Ohio State University

Eligibility Criteria

This trial is for individuals aged 18-50 with confirmed bone loss of the hip who have agreed to minimally invasive repair. Participants will undergo a procedure where bone marrow liquid is collected from both hips using two different systems, but only one type will be used to aid healing.

Inclusion Criteria

I am having hip surgery for bone cysts or bone tissue death.

Exclusion Criteria

I have diabetes.

Patients with a history of bone marrow aspirate

I have had leukemia, lymphoma, or another bone marrow disease in the past.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Collection of bone marrow aspirate from both hips using Zimmer Biomet Biocue and Marrow Cellution systems, and blood draw for protein solution analysis

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• Marrow Cellution™

Trial Overview The study compares the standard Zimmer Biomet Biocue system for collecting and concentrating bone marrow liquid against the novel Marrow Cellutions system™. The effectiveness in aiding healing after hip repair surgery is being analyzed.

Participant Groups

Group I: Bilateral Hip Bone Marrow Collection Experimental Treatment 1 Intervention

Collection of bone marrow aspirate from both hips. One collected using the Zimmer Biomet Biocue system and the other using the Marrow Cellution system.

Marrow Cellution™ is already approved in United States for the following indications:

Approved in United States as Marrow Cellution for:

• Bone loss of the hip
• Orthopedic applications

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Findings from Research

The study introduces a novel acetabular approach for aspirating bone marrow during total hip arthroplasty, which simplifies the process of obtaining bone marrow aspirate concentrate for biological augmentation.

This method aims to reduce patient morbidity, surgery time, and costs compared to traditional iliac crest marrow aspiration, making it a more efficient option for a large patient cohort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acetabular Bone Marrow Aspiration During Total Hip Arthroplasty. Ruoss, S., Ball, ST., Dorn, SN., et al.[2023]

The novel SSLM method for bone marrow aspiration using the Marrow Cellutions system produced significantly higher concentrations of colony-forming unit fibroblasts (CFU-f) compared to traditional bone marrow concentrates (BMAC) derived from centrifugation, indicating enhanced efficacy in cell recovery.

In a study involving 30 patients, the SSLM draws also yielded comparable levels of important stem/progenitor cells (CD34+ and CD117+), suggesting that this method is not only effective but also offers practical advantages over existing techniques due to its speed and simplicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Isolation of clinically relevant concentrations of bone marrow mesenchymal stem cells without centrifugation. Scarpone, M., Kuebler, D., Chambers, A., et al.[2020]

The study presents a method for effectively concentrating bone marrow using an intermittent flow cell separator, which minimizes manipulation and reduces the risk of contamination.

This method achieved an 86.8% depletion of mature granulocytes and a 97.7% reduction in red cells, while recovering 49% of mononuclear cells, which successfully engrafted after being purged or cryopreserved.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effective concentration of bone marrow mononuclear cells using density gradient separation within an automated cell separator. Baker, PK., Rhodes, EG., Duguid, JK.[2017]

The systematic review analyzed 12 studies on Concentrated Bone Marrow Aspirate (CBMA) for knee osteoarthritis, revealing a mix of evidence quality, with three high-quality studies indicating potential efficacy of CBMA compared to placebo and other treatments.

The overview also emphasized the need for further research to address gaps in evidence regarding CBMA's effectiveness, safety, and resource utilization in treating knee osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

AAOS Technology Overview Summary: Concentrated Bone Marrow Aspirate for Knee Osteoarthritis. Aneja, A., Adams, SB., Foster, JA., et al.[2023]

The IBM 2991 blood cell processor effectively concentrates mononuclear cells from large volumes of bone marrow, achieving an average recovery rate of 78.3% for mononuclear cells and 67.5% for CFU-GM across 22 samples.

The procedure maintains high cell viability, with 97.1% of cells being viable, which is crucial for ensuring the quality of bone marrow for procedures like autologous grafts or allogeneic bone marrow transplants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Method for concentrating marrow stem cells using the IBM 2991 washer. Necessary preparation before in vitro treatment of bone marrow by pharmacologic or immunologic means]. Hervé, P., Coffe, C., Peters, A.[2019]

The method described for collecting bone marrow using 'Wiktor's' needles and specialized filters ensures a high-quality single cell suspension, which is crucial for effective transplantation.

In a study of 10 consecutive marrow collections, this technique successfully gathered enough marrow cells for engraftment while maintaining an acceptable level of risk for the donor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bone marrow transplantation in Polish conditions. A modified method of marrow collection and preparation for transplantation. Jedrzejczak, WW., Pojda, Z.[2006]

In a recent UK survey of 20,323 bone marrow biopsy procedures, only 15 adverse events were reported, indicating that complications are rare.

The majority of the reported adverse events were hemorrhagic, highlighting the need for ongoing documentation to better understand the risks associated with this procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Morbidity associated with bone marrow aspiration and trephine biopsy - a review of UK data for 2004. Bain, BJ.[2022]

The powered bone marrow aspiration and biopsy device significantly reduced patient-reported pain during needle insertion (2.6 vs 4.1 on a pain scale) and decreased procedural time (100 seconds vs 224 seconds) compared to the traditional manual method, indicating improved patient comfort and efficiency.

Specimens obtained with the powered device were larger and of better quality (25.4 mm² vs 11.9 mm²), enhancing diagnostic yield and potentially reducing the need for repeat procedures, while no complications were reported in either method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective randomised study of a rotary powered device (OnControl) for bone marrow aspiration and biopsy. Swords, RT., Anguita, J., Higgins, RA., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Acetabular Bone Marrow Aspiration During Total Hip Arthroplasty. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Isolation of clinically relevant concentrations of bone marrow mesenchymal stem cells without centrifugation. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Effective concentration of bone marrow mononuclear cells using density gradient separation within an automated cell separator. [2017]

4. United States pubmed.ncbi.nlm.nih.gov

AAOS Technology Overview Summary: Concentrated Bone Marrow Aspirate for Knee Osteoarthritis. [2023]

5. France pubmed.ncbi.nlm.nih.gov

[Method for concentrating marrow stem cells using the IBM 2991 washer. Necessary preparation before in vitro treatment of bone marrow by pharmacologic or immunologic means]. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Bone marrow transplantation in Polish conditions. A modified method of marrow collection and preparation for transplantation. [2006]

7. Italy pubmed.ncbi.nlm.nih.gov

Morbidity associated with bone marrow aspiration and trephine biopsy - a review of UK data for 2004. [2022]

8. England pubmed.ncbi.nlm.nih.gov

A prospective randomised study of a rotary powered device (OnControl) for bone marrow aspiration and biopsy. [2022]