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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore new methods for collecting and using bone marrow liquid to heal bone loss in the hip. Researchers will compare two systems for collecting bone marrow liquid, applying one to the hip requiring surgery and another to the non-surgical hip. This trial targets individuals aged 18-50 undergoing hip surgery due to bone issues such as subchondral bone cysts (fluid-filled sacs under the joint surface) or avascular necrosis (bone tissue death from poor blood supply). Participants will have bone marrow collected from both hips and blood drawn, but only the marrow from the surgical side will aid in healing, while the rest undergoes laboratory analysis. As an unphased trial, this study allows participants to contribute to innovative research that could lead to new treatments for bone loss.

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 prior data suggests that the Marrow Cellution system is safe for bone marrow collection?

Research shows that using the Marrow Cellution™ system to collect bone marrow is safe. Studies have found that bone marrow injections collected with Marrow Cellution™ have been safely used in patients with hip osteoarthritis, reducing pain and improving joint function without major problems.

One study found that bone marrow injections for osteoarthritis were well-tolerated in a small group of patients, indicating no significant side effects.

Overall, evidence suggests that the Marrow Cellution™ system is safe for collecting bone marrow. The reviewed studies report no serious issues or complications, making it a safe option for patients considering clinical trials involving this treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Marrow Cellution™ system because it offers a novel way to collect bone marrow for treating hip arthritis. Unlike traditional treatments that might rely on medications or joint replacements, this method taps directly into your body's regenerative potential by collecting bone marrow aspirate from both hips. The Marrow Cellution™ system is designed to efficiently harvest bone marrow cells, potentially enhancing the body's natural healing processes. This method could offer a more targeted and less invasive alternative to standard treatments, paving the way for quicker recovery and improved joint function.

What evidence suggests that the Marrow Cellution™ system is effective for bone marrow collection in hip arthritis?

Research has shown that the Marrow Cellution system may help treat hip arthritis. Studies have found that using bone marrow from this system can reduce pain and improve movement in patients for up to a year. In this trial, participants will undergo bilateral hip bone marrow collection, with one hip using the Marrow Cellution system and the other using the Zimmer Biomet Biocue system. The Marrow Cellution method does not require a centrifuge, collecting high-quality bone marrow without spinning the blood. This process helps maintain the purity of the bone marrow and may lead to better results. These findings suggest that this technology could be a good option for people with hip arthritis. ^{1 3 6 7 8}

Who Is on the Research Team?

William K Vasileff, MD

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11208346/

Safety and Efficacy of Bone-Marrow Aspirate Concentrate ... The results from this review demonstrated that administration of BMAC is safe and potentially efficacious in terms of reducing pain, improving function and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11372984/

Bone marrow aspirate injection for osteoarthritis of the hip In patient with mild, moderate, and severe hip OA, BMA may be an alternative treatment that improves pain and function in patients for as long as 12 months.

3. aspire-medical.eu aspire-medical.eu/marrowcellution/evidence-for-centrifuge-free-bone-marrow-harvesting/

The Evidence for Centrifuge-Free Bone Marrow Harvesting ... Marrow Cellution™ revolutionizes bone marrow aspiration by providing a centrifuge-free method that ensures high-quality aspirate with minimal ...

4. cervos.com cervos.com/wp-content/uploads/BMA_ThoughtLeadership_V6.pdf

Advancing Clinical Outcomes through Enhanced Bone ... These publications report positive outcomes, both clinical and cellular, derived from the use of Marrow Cellution technology, contributing to a growing body of ...

5. arthroscopytechniques.org arthroscopytechniques.org/article/S2212-6287(25)00290-7/fulltext

Centrifuge-Free Bone Marrow Aspirate Harvest for ... In this technique, we describe a centrifuge-free BMA harvest system (Marrow Cellution; Cervos Medical) that avoids peripheral blood dilution ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2772594422001613

Bone marrow aspirate injection for osteoarthritis of the hip In patient with mild, moderate, and severe hip OA, BMA may be an alternative treatment that improves pain and function in patients for as long as 12 months.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8363189/

Cellular and clinical analyses of autologous bone marrow ... Intra-articular BMA injections for knee OA in a small pilot cohort appeared to be safe with potential therapeutic value.

8. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1155/2022/5394441

Short‐Term Efficacy of Using a Novel Low‐Volume Bone ... Intra-articular bone marrow concentrate (BMC) and aspirate (BMA) injections have been used with mixed results to treat osteoarthritis (OA).