KUR-113 Bone Graft for Degenerative Disc Disease

(STRUCTURE Trial)

Not currently recruiting at 21 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)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new bone graft treatment called KUR-113 for individuals with Degenerative Disc Disease (DDD), a condition where spinal discs deteriorate, often causing back and leg pain. Researchers aim to determine if KUR-113 is safe and more effective than the current standard treatment, which uses autologous bone grafting. Participants will be randomly assigned to receive either the new treatment or the standard one. The trial seeks participants with DDD causing leg pain, who have tried other treatments unsuccessfully for six months, and are willing to undergo a specific surgical procedure. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the KUR-113 Bone Graft, which uses a compound called TGplPTH1-34 mixed with fibrin, is under study for treating Degenerative Disc Disease (DDD). This new treatment is compared to the usual method of using a bone graft taken from the patient's own body.

Earlier studies found that the TGplPTH1-34 in fibrin treatment is generally well-tolerated, with most participants not experiencing serious side effects. Safety data indicates that patients have not encountered major problems related to this treatment. Researchers carefully monitored and adjusted the amount and concentration used in these studies based on safety information, ensuring its safety.

Although this treatment remains under investigation, the information suggests it is relatively safe. Prospective trial participants should discuss all possible risks and benefits with their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Most treatments for degenerative disc disease involve surgical intervention, such as spinal fusion, which relies on the body's natural healing processes or the use of bone grafts. However, KUR-113 Bone Graft is unique because it incorporates TGplPTH1-34, a synthetic peptide that mimics a natural hormone involved in bone growth and repair, delivered within a fibrin matrix. Researchers are excited because this approach aims to enhance bone healing and spinal stability more effectively than traditional methods. Additionally, the use of a polyetheretherketone (PEEK) intervertebral cage with TGplPTH1-34 offers a novel way to support the spine while potentially accelerating recovery. This innovative combination could lead to improved outcomes for patients with degenerative disc disease.

What evidence suggests that this trial's treatments could be effective for Degenerative Disc Disease?

Research has shown that the KUR-113 Bone Graft, which uses a special protein in a gel, offers promising results for treating Degenerative Disc Disease (DDD). In this trial, participants will receive either the KUR-113 Bone Graft or an Autologous Bone Graft at random. Other studies have reported that the KUR-113 treatment achieved similar success rates in bone healing and connection after surgery compared to traditional bone graft methods. These success rates are crucial as they reflect the bones' recovery. Notably, the results also demonstrated excellent patient outcomes, indicating effective healing and recovery. This suggests that KUR-113 could serve as a strong alternative to conventional bone grafts in spinal surgeries. ^{1 3 6 7 8}

Who Is on the Research Team?

John Chi, MD

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04294004

KUR-113 Bone Graft Versus Local Autograft for the ... 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 ...

2. kurosbio.com kurosbio.com/resources/kuros-biosciences-announces-results-from-two-prospective-randomized-clinical-trials-structure-and-maxa/

STRUCTURE and MAXA In the STRUCTURE trial, Fibrin-PTH, while demonstrating excellent clinical outcomes, showed fusion rates comparable to autograft in the less ...

3. withpower.com withpower.com/trial/phase-3-intervertebral-disc-degeneration-7-2020-42db1

KUR-113 Bone Graft for Degenerative Disc Disease 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 ...

4. kurosbio.com kurosbio.com/wp-content/uploads/2025/01/Kuros_FPI_KUR-113FINAL20200831.pdf

Kuros Biosciences Announces Treatment of the First ... Spinal fusion may be recommended for conditions such as spondylolisthesis, degenerative disc disease or recurrent disc herniations. The goal of fusion surgery ...

5. finance.yahoo.com finance.yahoo.com/news/kuros-biosciences-announces-results-two-062000468.html

Kuros Biosciences Announces Results from Two ... In the MAXA trial, standalone MagnetOs outperformed the gold standard autograft by 73% in posterior spinal fusion in a difficult-to-treat ...

6. kurosbio.com kurosbio.com/wp-content/uploads/2023/12/fncls.pdf

Ad hoc announcement pursuant to ... The STRUCTURE trial is investigating the safety and efficacy of Fibrin-PTH (KUR-113) in single- level transforaminal lumbar interbody fusion ( ...

7. clinicaltrials.ucbraid.org clinicaltrials.ucbraid.org/trial/NCT04294004

KUR-113 Bone Graft Versus Local Autograft for the Treatment ... 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 ...

8. indianaspinegroup.com indianaspinegroup.com/clinical-trials-enrollment/

Clinical Trials & Registries (Enrollment) The BioBase electronic data-capturing platform provides Indiana Spine Group with comprehensive surgical outcome analytics that assess changes in pain, quality ...