KUR-113 Bone Graft for Degenerative Disc Disease

(STRUCTURE Trial)

Recruiting at 19 trial locations

Overseen By Bhavana Shivakumar

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Kuros Biosurgery AG

Must not be taking: Teriparatide, Abaloparatide, Systemic steroids

Disqualifiers: Diabetes, Osteoporosis, Malignancy, 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: 7

Duration: Initial hospital discharge (on average 3 days post-surgery)

50 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the safety and efficacy of KUR-113 Bone Graft (TGplPTH1-34 in fibrin) compared to local autograft for the treatment of Degenerative Disk Disease (DDD).

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on chronic systemic steroids, you must not have taken them for more than 14 consecutive days within 6 months prior to the screening visit.

What data supports the effectiveness of the treatment KUR-113 Bone Graft for Degenerative Disc Disease?

Research shows that using recombinant human bone morphogenetic protein-2 (rhBMP-2), which is similar to the TGplPTH1-34 in fibrin used in KUR-113, can help in bone fusion and healing in spinal surgeries. This suggests that the components in KUR-113 might also be effective in promoting bone growth and healing in degenerative disc disease. ^{1 2 3 4 5}

Is KUR-113 Bone Graft safe for use in humans?

Research on similar treatments, like recombinant human platelet-derived growth factor combined with beta-tricalcium phosphate, shows they are generally safe for use in bone graft procedures, such as joint fusion, without significant safety concerns. ^{6 7 8 9 10}

How is the KUR-113 Bone Graft treatment for Degenerative Disc Disease different from other treatments?

The KUR-113 Bone Graft treatment is unique because it uses an autologous bone graft combined with TGplPTH1-34 in fibrin, which may enhance bone healing and integration compared to traditional bone grafts. This combination could potentially reduce the need for additional surgeries and improve recovery outcomes. ^{2 11 12 13 14}

Research Team

John Chi, MD

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

Adults aged 25-75 with Degenerative Disc Disease who've tried other treatments like physical therapy or medications for at least 6 months without success. They must have specific spinal conditions, agree to contraception if applicable, and not be pregnant. Excluded are those with certain bone diseases, high BMI, diabetes with poor control, history of cancer or immune disorders, current smokers, and known allergies to trial materials.

Inclusion Criteria

I have degeneration in my spinal joints.

My back pain significantly limits my daily activities.

You have significant leg pain with a score of 40 or higher on a pain scale.

Exclusion Criteria

I have a bone condition that could affect healing.

I have been diagnosed with invasive skin cancer.

I currently have an infection.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo single-level transforaminal lumbar interbody fusion with either KUR-113 Bone Graft or local autograft

Initial hospital discharge (on average 3 days post-surgery)

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment through clinical and radiological assessments

24 months

Visits at 6 weeks, 3, 6, 12, and 24 months post-surgery

Treatment Details

Interventions

• Autologous Bone Graft
• TGplPTH1-34 in fibrin

Trial Overview The study is testing KUR-113 Bone Graft (a combination of a drug called TGplPTH1-34 in a fibrin matrix) against the standard procedure using the patient's own bone graft. The goal is to see which works better for spinal fusion surgery in patients with degenerative disc disease.

Participant Groups

Group I: KUR-113, Stage 2 Experimental Treatment 1 Intervention

During stage 2, subjects will receive TGplPTH1-34 in fibrin that will be applied within and around a PEEK intervertebral cage at a concentration of 0.7mg/ml. The concentration received was selected by the DSMB based on the results of stage 1. The maximum dose that will be applied is 7 mg of TGplPTH1-34 in 10mL KUR-113 Bone Graft.

Group II: KUR-113, Stage 1 Experimental Treatment 1 Intervention

During stage 1, subjects randomized to this arm will receive TGplPTH1-34 in fibrin (0.4mg/ml) that will be applied within and around a polyetheretherketone (PEEK) intervertebral cage. The maximum dose that will be applied is 4 mg of TGplPTH1-34 in 10mL KUR-113 Bone Graft.

Group III: Autologous Bone Graft Active Control 1 Intervention

During stage 1 of the study, subjects randomized to this arm will receive local autologous bone graft. In the event of insufficient local autograft, Iliac crest bone graft may be used to supplement.

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+

Avania

Industry Sponsor

Trials

59

Recruited

10,000+

Factory CRO

Industry Sponsor

Trials

7

Recruited

8,100+

Findings from Research

In a multicenter randomized controlled trial involving 132 patients treated with rhPDGF-BB/β-TCP-collagen and 35 patients receiving autograft, the rhPDGF-BB/β-TCP-collagen treatment demonstrated noninferiority in achieving joint fusion and clinical healing outcomes compared to autograft.

The use of rhPDGF-BB/β-TCP-collagen resulted in less pain and lower morbidity than traditional autograft methods, making it a safer and effective alternative for ankle and hindfoot fusion procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recombinant Human Platelet-Derived Growth Factor BB in Combination With a Beta-Tricalcium Phosphate (rhPDGF-BB/β-TCP)-Collagen Matrix as an Alternative to Autograft. Daniels, TR., Anderson, J., Swords, MP., et al.[2022]

In a study involving 60 patients undergoing hindfoot or midfoot fusion, the synthetic bone graft material Augment Bone Graft (rhPDGF/TCP) was found to be safe, with no serious adverse events reported over a 36-week follow-up period.

At 36 weeks, 75% of patients showed moderate to complete bone bridging at the fusion sites, indicating that rhPDGF/TCP is effective in promoting bone healing and supports further research comparing it to traditional autograft bone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective clinical pilot trial in a single cohort group of rhPDGF in foot arthrodeses. Daniels, T., DiGiovanni, C., Lau, JT., et al.[2016]

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]

In a Phase I/II clinical trial involving 11 patients with degenerative disc disease, the implantation of autologous mesenchymal stromal cells (MSCs) embedded in tricalcium phosphate was found to be safe, with no adverse effects related to the cell implantation reported.

Efficacy results showed significant improvements in pain and disability scores post-surgery, with 80% of patients achieving successful lumbar fusion by the end of the follow-up period, suggesting that MSCs could be a viable alternative to traditional bone grafts in spinal fusion procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autologous mesenchymal stromal cells embedded in tricalcium phosphate for posterolateral spinal fusion: results of a prospective phase I/II clinical trial with long-term follow-up. Blanco, JF., Villarón, EM., Pescador, D., et al.[2020]

References

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

A prospective, randomized, controlled cervical fusion study using recombinant human bone morphogenetic protein-2 with the CORNERSTONE-SR allograft ring and the ATLANTIS anterior cervical plate. [2022]

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

Anterior cervical interbody fusion with rhBMP-2 and tantalum in a goat model. [2019]

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

Initial fusion rates with recombinant human bone morphogenetic protein-2/compression resistant matrix and a hydroxyapatite and tricalcium phosphate/collagen carrier in posterolateral spinal fusion. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Single-center, consecutive series study of the use of a novel platelet-rich fibrin matrix (PRFM) and beta-tricalcium phosphate in posterolateral lumbar fusion. [2020]

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

Comparison between allograft plus demineralized bone matrix versus autograft in anterior cervical fusion. A prospective multicenter study. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Fusion rate and clinical outcome in anterior lumbar interbody fusion with beta-tricalcium phosphate and bone marrow aspirate as a bone graft substitute. A prospective clinical study in fifty patients. [2019]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Comparative Evaluation of Mineralized Bone Allografts for Spinal Fusion Surgery. [2023]

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

Recombinant Human Platelet-Derived Growth Factor BB in Combination With a Beta-Tricalcium Phosphate (rhPDGF-BB/β-TCP)-Collagen Matrix as an Alternative to Autograft. [2022]

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

Prospective clinical pilot trial in a single cohort group of rhPDGF in foot arthrodeses. [2016]

10. 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]

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

Case report: Tuberculosis recall on bone graft patient. [2023]

12. Netherlands pubmed.ncbi.nlm.nih.gov

[Anterior discectomy as treatment for a cervical radicular syndrome]. [2011]

13. England pubmed.ncbi.nlm.nih.gov

Autologous mesenchymal stromal cells embedded in tricalcium phosphate for posterolateral spinal fusion: results of a prospective phase I/II clinical trial with long-term follow-up. [2020]

14. Germany pubmed.ncbi.nlm.nih.gov

[Comparison of anterior lumbar fusion rates after circumferential fusion using beta-tricalcium phosphate (Cerasorb) versus autologous iliac crest spongiosa]. [2016]