Genex for Avascular Necrosis

(Genex Trial)

Overseen By Laura Stiegel

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Cleveland Clinic

Disqualifiers: Pregnancy, Incarceration, Language barrier

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

Compensation: Varies

Number of Visits: 6

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to treating early-stage osteonecrosis of the femoral head, a condition where bone tissue in the hip starts to die due to lack of blood flow. The researchers aim to evaluate the effectiveness of a bone graft substitute, Genex, when combined with core decompression and an injection of bone marrow concentrate. Suitable candidates have osteonecrosis of the hip and receive a recommendation from their doctor for a core decompression procedure. Participants should be prepared to follow the study's guidelines and attend all follow-up appointments. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in osteonecrosis treatment.

Do I need to stop my current medications for the trial?

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

What prior data suggests that this method is safe for patients undergoing core decompression of the hip?

Research has shown that using Genex with autologous bone marrow cells (ABMC) has been tested for safety in earlier studies. One study found that using bone marrow during a procedure called core decompression was generally safe, with patients experiencing only a few minor side effects.

Other studies have examined treatments using autologous cells, like ABMC, and found them to be safe. For instance, a study that followed patients for 10 years reported good results without major safety issues.

Overall, using Genex and ABMC together for bone conditions appears safe based on past research. However, individual reactions can vary, and participation in a clinical trial involves close monitoring for any side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Most treatments for early-stage osteonecrosis of the femoral head involve surgical procedures like core decompression to relieve pressure and improve blood flow. However, the use of Genex is unique because it combines an injection of autologous bone marrow concentrate with Genex Bone Graft Substitute as an adjunct to the core decompression procedure. This combination aims to enhance bone regeneration and healing, offering a potentially more effective solution than traditional methods. Researchers are excited about this approach because it leverages the body's natural healing capabilities with advanced materials, which could lead to improved outcomes for patients.

What evidence suggests that the Genex treatment might be effective for hip conditions?

Studies have shown that using Genex with a patient's own bone marrow during core decompression can be promising for treating bone tissue death in the hip joint. In this trial, participants will receive an injection of autologous bone marrow concentrate along with Genex® Bone Graft Substitute as an adjunct to the core decompression procedure. This method creates a path for the bone graft substitute and bone marrow, encouraging new bone growth. Research indicates that this approach can improve recovery and support bone healing. Early findings suggest that patients experience less pain and better joint movement. While more data is being collected, the combination of Genex and autologous bone marrow shows potential for effectively managing early-stage bone tissue death. ^{1 2 3 6 7}

Who Is on the Research Team?

Nicolas Piuzzi

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

Inclusion Criteria

Subject must be physically and mentally willing and able, in the Investigator's opinion at the time of enrollment, to be compliant with the protocol and complete the study protocol and follow ups

Surgeon considers the patient appropriate for the core decompression procedure of the hip

Subject provides voluntarily signature on the IRB approved Informed Consent Form

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo core decompression of the hip with injection of autologous bone marrow concentrate and Genex® Bone Graft Substitute

12 months

Multiple visits for surgical procedure and follow-up assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 6 weeks, 12 weeks, 6 months, and 12 months

12 months

Follow-up visits at 6 weeks, 12 weeks, 6 months, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Genex

How Is the Trial Designed?

Group I: Genex with ABMC Experimental Treatment 1 Intervention

Injection of autologous bone marrow concentrate and the use of genex® Bone graft Substitute as an adjunct associated with the Core decompression procedure

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

Biocomposites Ltd

Industry Sponsor

Trials

6

Recruited

270+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05706909

Study Details | NCT05706909 | The Use of Genex in the ... The purpose of this study is to assess the clinical and x-ray results of patients who are treated with core decompression of the hip and the injection of a bone ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11874654/

Personalizing core decompression grafting technique for ... We introduce a mathematical method to be utilized intraoperatively to calculate the volume of bone resected during core decompression with an expandable reamer.

3. josr-online.biomedcentral.com josr-online.biomedcentral.com/articles/10.1186/s13018-025-05606-5

Personalizing core decompression grafting technique for ... We introduce a mathematical method to be utilized intraoperatively to calculate the volume of bone resected during core decompression with an expandable reamer.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4821226/

Core Decompression and Autologous Bone Marrow ... The aim of this study was to investigate the safety of injection of bone marrow aspirate concentrate during core decompression and to study its clinical

5. journals.sagepub.com journals.sagepub.com/doi/10.1177/20417314241310541

Innovative solutions for osteonecrosis of the femoral head Localized cell-based therapy relies on core decompression to create a bone tunnel, which serves as a pathway for implanting materials containing ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03787329

Autologous Bone Marrow Concentration for Avascular ... This study aims to evaluate the effect of bone marrow concentration on avascular necrosis of femur head by comparing clinical and imaging outcomes between ...

7. stemcellres.biomedcentral.com stemcellres.biomedcentral.com/articles/10.1186/s13287-020-01810-8

10-year follow-up results of the prospective, double ... The 10-year follow-up results of this prospective, double-blinded, randomized, controlled study showed that the use of autologous BBC in combination with core ...