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KUR-113 Bone Graft for Degenerative Disc Disease (STRUCTURE Trial)
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.
STRUCTURE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSTRUCTURE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.STRUCTURE Trial Design
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Who is running the clinical trial?
Media Library
- I have degeneration in my spinal joints.I have a bone condition that could affect healing.My back pain significantly limits my daily activities.I have been diagnosed with invasive skin cancer.I currently have an infection.I currently have COVID-19.You have a history of substance abuse or a mental illness that may affect your recovery or ability to follow the study's instructions.My growth plates are still open.I haven't been in a drug study in the last 3 months or a device study in the last 30 days.You are currently a smoker.My degenerative disc disease is due to a tumor.You have significant leg pain with a score of 40 or higher on a pain scale.I have had spinal fusion surgery or an attempt at it before.I need or might need more than one spinal fusion or another surgery within a year.The radiographs showed that the ankle joint was unstable, with an angulation of more than 5 degrees or translation of more than 3 mm on flexion/extension radiographs."Osteophyte formation at facet joints or vertebral endplates" means that excess bone growth will form at the joints between the vertebrae or at the endplates of the vertebrae.You have thickened or scarred tissue in your back that may affect your ability to participate in the study.I need radiotherapy or drugs that affect my immune system for a health condition.I am between 25 and 75 years old and, if female, not pregnant and agree to use contraception.I have severe lower back and leg pain due to a spine condition needing surgery.I need urgent surgery to relieve pressure on my spinal cord or to fuse my spine.I have a condition that causes high calcium levels in my blood.I have or had another type of cancer.I have been on steroids for more than 2 weeks in the last 6 months.The patient agrees to the surgery by signing a form that says they have been informed of the risks and benefits of the surgery.I have had radiation therapy on my bones.I am between 25 and 75 years old and, if female, not pregnant and agree to use contraception.I have used teriparatide, abaloparatide, or graft material with PTH1-34.I have Paget's Disease or unusually high alkaline phosphatase levels.I have a slipped or worn-out disc in my spine.The disc height decreased by more than two millimeters at certain spinal levels.I have a history of thyroid autoimmune disease or hyperthyroidism.I have tried non-surgical treatments for my condition for 6 months without improvement.I have a genetic condition that increases my risk for bone cancer.I have had spine surgery to join two or more bones together before.My back pain significantly limits my daily activities.
- Group 1: Autologous Bone Graft
- Group 2: KUR-113, Stage 2
- Group 3: KUR-113, Stage 1
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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