Status:
UNKNOWN
KUR-113 Bone Graft Versus Local Autograft for the Treatment of Single-level Transforaminal Lumbar Interbody Fusion
Lead Sponsor:
Kuros Biosurgery AG
Collaborating Sponsors:
Avania
Kuros BioSciences B.V.
Conditions:
Degenerative Disc Disease
Spinal Fusion
Eligibility:
All Genders
25-75 years
Phase:
PHASE2
Brief Summary
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).
Detailed Description
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. Th...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04294004
Start Date
August 27 2020
End Date
July 30 2025
Last Update
August 9 2023
Active Locations (15)
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1
University of California San Diego
La Jolla, California, United States, 92093-0863
2
Justin Parker Neurological Institute
Boulder, Colorado, United States, 80303
3
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007
4
Northwestern University-Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611