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Bone Graft

KUR-113 Bone Graft for Degenerative Disc Disease (STRUCTURE Trial)

Phase 2

Waitlist Available

Led By John Chi, MD

Research Sponsored by Kuros Biosurgery AG

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female patient ≥ 25 up to and including 75 years old. Females of childbearing potential with a negative urine pregnancy test at Screening. Females of childbearing potential must agree to use acceptable contraception for at least 12 months after surgery and investigational product placement.

disc degeneration and/or herniation

Must not have

Patients with open epiphyseal plates.

Patient requiring emergency spinal decompression or spinal fusion.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 6, month 3, month 6, month 12, and month 24 post-surgery

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the safety and effectiveness of a new bone graft to the current standard treatment for degenerative disk disease.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include typical surgical risks such as infection or reaction to anesthesia. Specific side effects related to KUR-113 could involve allergic reactions to its components or complications from new bone growth stimulation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 25 and 75 years old and, if female, not pregnant and agree to use contraception.

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I have a slipped or worn-out disc in my spine.

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My back pain significantly limits my daily activities.

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I have severe lower back and leg pain due to a spine condition needing surgery.

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My back pain significantly limits my daily activities.

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I have tried non-surgical treatments for my condition for 6 months without improvement.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My growth plates are still open.

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I need urgent surgery to relieve pressure on my spinal cord or to fuse my spine.

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I need or might need more than one spinal fusion or another surgery within a year.

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I have had spine surgery to join two or more bones together before.

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I have had spinal fusion surgery or an attempt at it before.

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I have used teriparatide, abaloparatide, or graft material with PTH1-34.

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I have a condition that causes high calcium levels in my blood.

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I have Paget's Disease or unusually high alkaline phosphatase levels.

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I have had radiation therapy on my bones.

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I have a bone condition that could affect healing.

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I need radiotherapy or drugs that affect my immune system for a health condition.

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I have a history of thyroid autoimmune disease or hyperthyroidism.

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I have been on steroids for more than 2 weeks in the last 6 months.

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My degenerative disc disease is due to a tumor.

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I have or had another type of cancer.

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I have a genetic condition that increases my risk for bone cancer.

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I have been diagnosed with invasive skin cancer.

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I currently have an infection.

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I currently have COVID-19.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 6, month 3, month 6, month 12, and month 24 post-surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 6, month 3, month 6, month 12, and month 24 post-surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 6, month 3, month 6, month 12, and month 24 post-surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Back Pain

Composite Endpoint

Leg Pain

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: KUR-113, Stage 2Experimental Treatment1 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 1Experimental Treatment1 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 GraftActive Control1 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.

0 / 25Eligibility criteria met