KUR-113 Bone Graft Versus Local Autograft for the Treatment of Single-level Transforaminal Lumbar Interbody Fusion
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).
A Prospective, Randomized, Controlled, Single-blind, Dose-finding, Multi-center, Parallel Group Study of Safety/Efficacy of KUR-113 Bone Graft Versus Local Autograft for the Treatment of Single-level Transforaminal Lumbar Interbody Fusion
Degenerative disc disease (DDD) is a common disorder of the lumbar spine. Clinically, DDD causes discogenic back pain and may cause related radicular, neuropathic, claudicatory, and referred pain. This is a prospective, randomized, controlled, single-blind, dose-finding, multi-center study which intends to demonstrate the safety and efficacy of KUR-113 Bone Graft (TGplPTH1-34 in fibrin) versus local autograft. The study will enroll 50 patients with Degenerative Disk Disease (DDD) requiring single-level interbody fusion along with posterolateral fusion (PLF) with posterior fixation who meet eligibility criteria and agree to participate in the study. Safety and efficacy of KUR-113 Bone Graft will be evaluated by analyzing all clinical as well as radiological endpoints and adverse events. This phase 2a study is not powered to detect non-inferiority. All patients will undergo clinical and radiological assessments at initial hospital discharge (on average 3 days post-surgery), 6 weeks, 3, 6, 12 and 24 months.
Degenerative Disc Disease Spinal Fusion Posterolateral Fusion MagnetOs Fibrin-PTH (KUR-113) Intervertebral Disc Degeneration TGplPTH1-34 in fibrin Autologous Bone Graft
You can join if…
Open to people ages 25-75
- Written informed consent by the patient.
- 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.
- Patients with degenerative disc disease with up to grade 1 spondylolisthesis and with leg pain requiring up to 3 levels of laminectomy/decompression and a single-level fusion (L2 - S1). DDD is defined by the presence of one or more of the following:
- instability (angulation ≥ 5 degrees or translation ≥ 3 mm on flexion/extension radiographs),
- osteophyte formation of facet joints or vertebral endplates,
- decreased disc height by > 2 mm, but dependent upon the spinal level,
- scarring/thickening of ligamentum flavum, annulus fibrosis or facet joint capsule,
- disc degeneration and/or herniation,
- facet degeneration,
- vacuum phenomenon.
- Patients with an Oswestry Disability Index (ODI) score ≥ 35.
- Patients with a Visual Analogue Scale (VAS) leg score ≥ 40.
- Failed conservative treatment (physical therapy, bed rest, medications, spinal injections or transcutaneous electrical nerve stimulation) for a period of 6 months prior to study enrollment.
- Patients willing to undergo PK sampling.
You CAN'T join if...
- Patients with open epiphyseal plates.
- Patient requiring emergency spinal decompression or spinal fusion.
- Patients requiring multilevel fusion or expected to need secondary intervention within one year following surgery.
- Any prior fusion or attempted fusion at an adjacent level.
- Any prior fusion or attempted fusion at the index level.
- Pregnant or breast-feeding women.
- Known or suspected allergies to any of the components of KUR-113 Bone Graft (e.g.
hypersensitivity to aprotinin).
- Any prior use of teriparatide or abaloparatide or graft material containing PTH1-34.
- Patients with hypercalcemic disorders (e.g., primary hyperparathyroidism).
- . Patients with Paget's Disease or unexplained high levels of alkaline phosphatase.
- . Prior radiation therapy involving bone.
- . Medical history or radiographic evidence of a metabolic bone disorder (e.g. Paget's Disease) or other condition that would negatively impact the healing process.
- . Any medical condition requiring radiotherapy or immunosuppression.
- . History of thyroid autoimmune disease (Hashimoto's thyroiditis, Graves' disease) or hyperthyroidism.
- . Patients on chronic systemic steroids (i.e. > 14 consecutive days) within 6 months prior to Screening Visit.
- . Osteopenia (T score < -1.0) or osteoporosis of the spine (T score < -2.5).
- . DDD related to benign or malignant tumor.
- . History or presence of active malignancy.
- . Hereditary disorders predisposing to osteosarcoma.
- . Patients with invasive skin cancer.
- . Evidence of local or systemic infection.
- . Patients with known active COVID-19 disease.
- . Current smokers.
- . Type 1 diabetes (regardless of HbA1c) or Type 2 diabetes with a documented HbA1c > 7.0.
- . Any acute or chronic concurrent medical conditions that in the Investigator's opinion are a contraindication to the procedure and study participation.
- . Participation in another investigational study within 30 days prior to surgery for investigational devices, or within the last three months for investigational drugs. (Note: trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials).
- . Known substance abuse, psychiatric disorder or a condition which, in the opinion of the investigator, may influence the healing or ability to comply with protocol requirements.
- . Involved in active litigation relating to his/her spinal condition or workers compensation claimants.
- . BMI greater than 40.
- University of California San Diego
accepting new patients
La Jolla California 92093-0863 United States
- Cedars Sinai Medical Center
accepting new patients
Los Angeles California 90048 United States
- accepting new patients
- Start Date
- Completion Date
- Kuros Biosurgery AG
- Phase 2
- Study Type
- Last Updated
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