MagnetOs Flex Matrix for Degenerative Disc Disease

(PRECISE Trial)

Recruiting at 3 trial locations

Overseen By Katherine Sage, DO

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kuros Biosurgery AG

Must not be taking: Calcium metabolism drugs

Disqualifiers: Pregnancy, Bone disorders, Infections, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 1 day (surgery)

100 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are receiving treatment with medication that interferes with calcium metabolism.

How does the MagnetOs Flex Matrix treatment differ from other treatments for degenerative disc disease?

MagnetOs Flex Matrix is unique because it uses a synthetic bone graft material that promotes bone growth and healing, which is different from traditional treatments that mainly focus on symptom relief. This approach may offer a more regenerative solution by encouraging the body's natural healing processes. ^{1 2 3 4 5}

What is the purpose of this trial?

This is a phase IV post-marketing study for MagnetOs Flex Matrix. MagnetOs Flex Matrix is a synthetic bone graft extender product that is routinely used by surgeons as a treatment for patients with degenerative disc disease and undergoing spinal fusion surgery. In this study, MagnetOs Flex Matrix will be used according to the latest U.S. Instructions For Use, specifically as a bone graft extender mixed with autograft in a 1:1 vol.% in the posterolateral spine. Trinity Elite will also be used according to its latest IFU approved in the US. Specifically, this cellular based allograft is an allograft intended for the treatment of musculoskeletal defects.

Eligibility Criteria

This trial is for adults over 18 with leg and/or back pain from degenerative disc disease needing up to four-level spinal fusion surgery (T11 - S1) after failing at least 3 months of non-surgical treatments. Participants must understand and consent to the study.

Inclusion Criteria

I tried other treatments like physical therapy or medications for over 3 months without success.

Patient is able to read/be read, understand, and provide written informed consent and has signed the Investigational Review Board (IRB) approved informed consent.

I need a spine surgery for my back or leg pain.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Treatment

Participants undergo up to four-level instrumented posterolateral fusion (PLF) procedure with MagnetOs Flex Matrix and Trinity Elite

1 day (surgery)

1 visit (in-person)

Post-operative Follow-up

Participants are monitored for safety and effectiveness with follow-up visits at discharge, Week 2, Week 6, Month 3, Month 6, and Month 12

12 months

6 visits (in-person)

Long-term Follow-up

Participants are monitored for long-term safety and effectiveness

12 months

Treatment Details

Interventions

• MagnetOs Putty

Trial Overview The study compares MagnetOs Flex Matrix, a synthetic bone graft extender, with Trinity Elite, a cellular-based allograft. Both are used in spinal fusion surgeries according to their U.S. instructions for use.

Participant Groups

Group I: MagnetOs Flex Matrix Experimental Treatment 1 Intervention

MagnetOs Flex Matrix use in instrumented posterolateral fusion, 5cc-10cc mixed with local autograft bone in a 1:1 ratio per spine level at the randomized assigned side

Group II: Trinity Elite Active Control 1 Intervention

Trinity Elite is a cryopreserved, viable cellular allograft containing cancellous bone and demineralized cortical bone designed for surgical use, applied per spine level at the contralateral side. Trinity Elite will be used as a bone graft extender (mixed with local autograft)

MagnetOs Putty is already approved in United States, European Union for the following indications:

Approved in United States as MagnetOs Flex Matrix for:

• Degenerative disc disease
• Spinal fusion surgery
• Posterolateral spine fusion
• Intervertebral disc space repair

Approved in European Union as MagnetOs Flex Matrix for:

• Degenerative disc disease
• Spinal fusion surgery
• Posterolateral spine fusion

Who Is Running the Clinical Trial?

Kuros Biosurgery AG

Lead Sponsor

Trials

11

Recruited

910+

Kuros BioSciences B.V.

Industry Sponsor

Trials

5

Recruited

310+

Simplified Clinical Data Systems, LLC

Industry Sponsor

Trials

7

Recruited

300+

Findings from Research

The study successfully developed a new surgical model to evaluate disc-like angle-ply structures (DAPS) as replacements for intervertebral discs in rats, demonstrating their stability in the spine.

DAPS showed effective cell infiltration from the surrounding area, which was enhanced by incorporating sacrificial layers, suggesting a promising approach for improving the integration of engineered disc replacements in future treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translation of an engineered nanofibrous disc-like angle-ply structure for intervertebral disc replacement in a small animal model. Martin, JT., Milby, AH., Chiaro, JA., et al.[2023]

New designs for total disk replacement were tested using finite element models to see how well they can replicate the mechanical function of the intervertebral disk, which is crucial for treating low back pain.

The study found that designs with a fiber jacket around elastomers or using hydrogels effectively mimicked the non-linear behavior of the natural disk, which is important for maintaining spinal motion and protecting surrounding tissues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design of next generation total disk replacements. van den Broek, PR., Huyghe, JM., Wilson, W., et al.[2017]

In a study involving 10 goats with induced intervertebral disc degeneration, a combination of a hydrogel and mesenchymal stem cells (MSCs) led to a significant 10% improvement in disc height and better histological conditions two weeks after treatment.

The hydrogel effectively localized to the disc area and reduced inflammation markers, suggesting that this combined therapy could be a promising approach to not only alleviate symptoms but also restore disc structure and function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined Hydrogel and Mesenchymal Stem Cell Therapy for Moderate-Severity Disc Degeneration in Goats. Zhang, C., Gullbrand, SE., Schaer, TP., et al.[2022]

The ADDISC total disc replacement (TDR) design successfully mimics the natural biomechanics of a healthy intervertebral disc, allowing for physiological motion and minimizing overload on the facet joints.

In extensive testing of 10 million cycles, the ADDISC TDR demonstrated excellent durability with minimal wear (140.96 mg) and no implant failures, indicating its potential for long-term use in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ADDISC lumbar disc prosthesis: Analytical and FEA testing of novel implants. Vanaclocha, A., Vanaclocha, V., Atienza, CM., et al.[2023]

Injecting a novel hydrogel into porcine spinal motion segments significantly restored angular stiffness and improved disc height after repeated flexion and extension, indicating its potential to enhance the mechanical integrity of degenerated intervertebral discs.

The study suggests that while the hydrogel can temporarily restore disc mechanics, continued repetitive stress can lead to a return to the original degenerated state, highlighting the need for careful management of mechanical loads post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of a novel injectable hydrogel nucleus pulposus replacement in restoring the mechanical properties of cyclically fatigued porcine intervertebral discs. Balkovec, C., Vernengo, J., McGill, SM.[2016]

References

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

Translation of an engineered nanofibrous disc-like angle-ply structure for intervertebral disc replacement in a small animal model. [2023]

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

Design of next generation total disk replacements. [2017]

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

Combined Hydrogel and Mesenchymal Stem Cell Therapy for Moderate-Severity Disc Degeneration in Goats. [2022]

4. England pubmed.ncbi.nlm.nih.gov

ADDISC lumbar disc prosthesis: Analytical and FEA testing of novel implants. [2023]

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

The use of a novel injectable hydrogel nucleus pulposus replacement in restoring the mechanical properties of cyclically fatigued porcine intervertebral discs. [2016]