KUR-113 Bone Graft Versus Local Autograft for the Treatment of Single-level Transforaminal Lumbar Interbody Fusion

Status unconfirmed · Phase 2

Conditions studied: Degenerative Disc Disease, Spinal Fusion

In brief

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).

Key facts

Study ID

NCT04294004

Run by

Kuros Biosurgery AG

People needed

50

Starts

2020-08-27

Expected to finish

2025-07-30

Last updated by the study team

2023-08-09

Who can join

Age: 25 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify 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.

Where it is running

• University of California San Diego — La Jolla, California, United States
• Justin Parker Neurological Institute — Boulder, Colorado, United States
• MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Northwestern University-Northwestern Memorial Hospital — Chicago, Illinois, United States
• Indiana Spine Group — Carmel, Indiana, United States
• Kansas Spine and Specialty Hospital — Wichita, Kansas, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Orthopedic Associates of Michigan — Grand Rapids, Michigan, United States
• Washington University in St. Louis — St Louis, Missouri, United States
• Hospital for Special Surgery — New York, New York, United States
• University at Buffalo Neurosurgery — Williamsville, New York, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
• University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States
• South Texas Spine Center — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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