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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 6, month 3, month 6, month 12, and month 24 post-surgery
Awards & highlights

STRUCTURE Trial 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.Check my eligibility
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.See study design
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.

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

STRUCTURE Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Back Pain
Composite Endpoint
Leg Pain
+4 more

STRUCTURE 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.

Find a Location

Who is running the clinical trial?

AvaniaIndustry Sponsor
40 Previous Clinical Trials
8,461 Total Patients Enrolled
Kuros BioSciences B.V.Industry Sponsor
3 Previous Clinical Trials
130 Total Patients Enrolled
Kuros Biosurgery AGLead Sponsor
10 Previous Clinical Trials
761 Total Patients Enrolled

Media Library

Autologous Bone Graft (Bone Graft) Clinical Trial Eligibility Overview. Trial Name: NCT04294004 — Phase 2
Degenerative Disc Disease Research Study Groups: Autologous Bone Graft, KUR-113, Stage 2, KUR-113, Stage 1
Degenerative Disc Disease Clinical Trial 2023: Autologous Bone Graft Highlights & Side Effects. Trial Name: NCT04294004 — Phase 2
Autologous Bone Graft (Bone Graft) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04294004 — Phase 2
Degenerative Disc Disease Patient Testimony for trial: Trial Name: NCT04294004 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many hospitals in America are participating in this trial?

"This study is currently enrolling patients at 17 different locations, which include Augusta University Medical Center in Augusta, MedStar Union Memorial Hospital in Baltimore, and Justin Parker Neurological Institute in Boulder."

Answered by AI

What other scientific investigations have included TGplPTH1-34 in fibrin?

"TGplPTH1-34's interactions with fibrin were first explored in 2016 by researchers at King Abdelaziz University. Since then, there have been 80 completed studies on the topic. Right now, 9 studies are actively recruiting participants, many of which are based in Augusta, Georgia."

Answered by AI

Does TGplPTH1-34 have negative effects when used to treat fibrin?

"While there is some data supporting the safety of TGplPTH1-34 in fibrin, it received a score of 2 because this is only a Phase 2 trial and there is no evidence yet that the drug is effective."

Answered by AI

Is this clinical trial open to people who are younger than 60 years old?

"As per the eligibility requirements for this trial, individuals must be aged between 25 and 75 to participate."

Answered by AI

Could I possibly qualify to take part in this medical study?

"This trial, which will have 50 participants in total, is only considering patients that suffer from intervertebral disc degeneration and are between 25-75 years old."

Answered by AI

Is there still room for participants in this research?

"That is correct, the clinicaltrials.gov website has this study listed as currently recruiting patients. This research was originally posted on 8/27/2020 and updated on 10/26/2022. The study requires 50 participants total, which will be recruited from 17 different locations."

Answered by AI

Who else is applying?

What state do they live in?
Missouri
Ohio
Michigan
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
Augusta University Medical Center
Orthopedic Associates of Michigan
Washington University in St. Louis
Other
How many prior treatments have patients received?
1
2
0
3+

Why did patients apply to this trial?

Ad on Facebook. Saw this on facebook. Intolerance to walking. To find out if this works.
PatientReceived 2+ prior treatments
Just trying to fix the pain.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

How long are visits? how long is the trial? Does it cover the neck? How long is each visit?
PatientReceived 2+ prior treatments
How long do visits take?
PatientReceived 1 prior treatment
~4 spots leftby Jul 2024