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

Recruiting in Palo Alto (17 mi)

+19 other locations

Overseen byJohn Chi, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Kuros Biosurgery AG

No Placebo Group

Prior Safety Data

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).

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.

+14 more

Exclusion Criteria

I have a bone condition that could affect healing.

I have been diagnosed with invasive skin cancer.

I currently have an infection.

+26 more

Participant Groups

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.

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.