ZetaFuse™ Bone Graft for Spinal Repair in Breast Cancer

(ZGMBC Trial)

Overseen By Joe Loy

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Zetagen Therapeutics, Inc

Must not be taking: Chronic steroids

Disqualifiers: Vertebral collapse, Spinal compression, Diabetes, Infection, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: Immediate

10 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing the ZetaFuse™ Bone Graft, a material used to repair bone damage in the spine caused by cancer. It targets patients with breast cancer that has spread to their bones, making their spine unstable. The graft is placed into the damaged area to support and strengthen the bone. Standard care for these patients includes treatments that help maintain bone strength.

Will I have to stop taking my current medications?

The trial requires that you do not use medications known to interfere with bone or soft tissue healing, like chronic systemic steroids. If you're on such medications, you may need to stop them to participate.

What data supports the effectiveness of the ZetaFuse™ Bone Graft treatment for spinal repair in breast cancer?

The ZetaMet™ Bone Graft, which is similar to ZetaFuse™, has shown promise in reducing pain and improving quality of life in a breast cancer patient with bone metastases, suggesting potential benefits for spinal repair. ^{1 2 3 4 5}

Is ZetaFuse™ Bone Graft safe for use in humans?

The safety of ZetaFuse™ Bone Graft, also known as SiCaP-30, was evaluated in a rabbit study, showing a high fusion rate without specific safety concerns reported. However, similar products like BMP/INFUSE have been associated with complications in humans, such as swelling and infection, when used in spinal surgeries. ^{6 7 8 9 10}

How is the ZetaFuse™ Bone Graft treatment different from other treatments for spinal repair in breast cancer?

ZetaFuse™ Bone Graft is unique because it likely involves a novel combination of materials, such as silicate-substituted calcium phosphate, which has shown promising results in bone fusion compared to traditional autografts. This treatment may offer an alternative to autografts, reducing complications like donor site pain and the need for additional surgeries. ^{6 10 11 12 13}

Eligibility Criteria

This trial is for women aged 22-75 with breast cancer that has spread to the spine, causing bone defects. They must have a life expectancy of at least 12 months, no more than five metastatic lesions in three sites or less, and be able to attend follow-up visits. Exclusions include spinal cord compression, allergies to device materials, certain medication use, diabetes, active infections like AIDS or hepatitis, recent smokers or those pregnant.

Inclusion Criteria

I have a cancerous lesion in the spine.

I am a woman diagnosed with breast cancer through tissue analysis.

I am between 22 and 75 years old.

Exclusion Criteria

Known allergy to Investigational Device materials

I am not on medications that could affect bone or tissue healing.

I have had a spinal bone collapse.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

ZetaMet™ (ZetaFuse™ Bone Graft) is percutaneously implanted into the vertebral body defect(s) created by the lytic metastatic tumor.

Immediate

1 visit (in-person)

Post-operative Care

Post-operative care will be per standard of care (SOC) at the Investigational Site.

84 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of SINS, pain, and vertebral body defect size.

180 days

Treatment Details

Interventions

• ZetaFuse™ Bone Graft

Trial Overview The ZetaFuse™ Bone Graft is being tested on patients with metastatic breast cancer in the spine. It's implanted into bone defects caused by tumors in the vertebral body. The graft aims to repair these defects and improve stability for patients who meet specific criteria regarding their spinal health and number of metastases.

Participant Groups

Group I: Investigational Device ZetaMet™ (ZetaFuse™ Bone Graft) Experimental Treatment 1 Intervention

ZetaMet™ (ZetaFuse™ Bone Graft) is percutaneously implanted into the bone defect created by the metastatic tumor in a spinal vertebral body. ZetaMet™ (ZetaFuse™ Bone Graft) is only for implantation into the vertebral body.

Who Is Running the Clinical Trial?

Zetagen Therapeutics, Inc

Lead Sponsor

Trials

2

Recruited

20+

Findings from Research

The off-label use of BMP/INFUSE in spine surgery has been linked to serious adverse events, including dysphagia, hematoma, and the need for intubation, as warned by the FDA in 2008.

Recent studies have highlighted that adverse events such as heterotopic ossification, infection, and retrograde ejaculation are under-reported, indicating significant perioperative and postoperative risks associated with BMP/INFUSE in spinal fusions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications due to the use of BMP/INFUSE in spine surgery: The evidence continues to mount. Epstein, NE.[2022]

In a study of 32 patients undergoing lumbar posterolateral fusion with PolyBone®, a beta-tricalcium phosphate synthetic graft, significant reductions in back and leg pain were observed over 12 months, with NRS scores dropping from 8.0 to 1.0 for leg pain and from 6.7 to 1.7 for back pain.

The fusion success rate was high, with 83.3% of patients achieving stage IV fusion bridges at 12 months, indicating that PolyBone® can effectively replace autologous bone grafts while minimizing donor site morbidity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiographic Analysis of Instrumented Posterolateral Fusion Mass Using Mixture of Local Autologous Bone and b-TCP (PolyBone®) in a Lumbar Spinal Fusion Surgery. Park, JH., Choi, CG., Jeon, SR., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Treating bone metastases with local therapy in a breast cancer patient resulted in decreased pain and prevented fracture. [2023]

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

Surgical treatment of bone metastases of the peripheral skeleton--a review of 33 cases. [2007]

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

Bone graft options for spinal fusion following resection of spinal column tumors: systematic review and meta-analysis. [2022]

4. Greece pubmed.ncbi.nlm.nih.gov

Surgical treatment of bone metastases in breast cancer. [2005]

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

Treatment of bone metastases and bone pain with bisphosphonates. [2020]

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

Assessment of SiCaP-30 in a Rabbit Posterolateral Fusion Model with Concurrent Chemotherapy. [2018]

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

Complications due to the use of BMP/INFUSE in spine surgery: The evidence continues to mount. [2022]

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

Bone graft substitutes for the promotion of spinal arthrodesis. [2006]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Bone Marrow Mesenchymal Stem Cells Expressing Baculovirus-Engineered Bone Morphogenetic Protein-7 Enhance Rabbit Posterolateral Fusion. [2018]

10. New Zealand pubmed.ncbi.nlm.nih.gov

BMP 2--Genetics Institute/ Medtronic-Sofamor Danek/Integra. Bone morphogenetic protein 2--Genetics Institute/ Medtronic-Sofamor Danek/Integra, INFUSE Bone Graft, recombinant human bone morphogenetic protein 2--Genetics Institute/Medtronic-Sofamor Danek/Integra, RhBMP 2--Genetics Institute/Medtronic-Sofamor Danek/Integra. [2018]

11. Germany pubmed.ncbi.nlm.nih.gov

Spinal Fusion of an Unstable Atlantoaxial Fracture in a Completely Tetraplegic Patient Using Silicate-Substituted Calcium Phosphate. [2018]

12. Korea (South) pubmed.ncbi.nlm.nih.gov

Radiographic Analysis of Instrumented Posterolateral Fusion Mass Using Mixture of Local Autologous Bone and b-TCP (PolyBone®) in a Lumbar Spinal Fusion Surgery. [2022]

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

Clinical and radiographic assessment of transforaminal lumbar interbody fusion using HEALOS collagen-hydroxyapatite sponge with autologous bone marrow aspirate. [2022]