KUR-113 Bone Graft Versus Local Autograft for the Treatment of Single-level Transforaminal Lumbar Interbody Fusion
NCT ID: NCT04294004
Last Updated: 2023-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
50 participants
INTERVENTIONAL
2020-08-27
2025-07-30
Brief Summary
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Detailed Description
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This is a prospective, randomized and non-randomized, controlled, single-blind and open-label, 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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KUR-113, Stage 1
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.
TGplPTH1-34 in fibrin
TGplPTH1-34 within a fibrin matrix applied within and around a polyetheretherketone (PEEK) intervertebral cage
Autologous Bone Graft
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.
Autologous Bone Graft
Local autograft collected from decompression which may be supplemented with iliac crest bone graft (ICBG) if local autograft is insufficient.
KUR-113, Stage 2
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.
TGplPTH1-34 in fibrin
TGplPTH1-34 within a fibrin matrix applied within and around a polyetheretherketone (PEEK) intervertebral cage
Interventions
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TGplPTH1-34 in fibrin
TGplPTH1-34 within a fibrin matrix applied within and around a polyetheretherketone (PEEK) intervertebral cage
Autologous Bone Graft
Local autograft collected from decompression which may be supplemented with iliac crest bone graft (ICBG) if local autograft is insufficient.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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.
3. 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:
1. instability (angulation ≥ 5 degrees or translation ≥ 3 mm on flexion/extension radiographs),
2. osteophyte formation of facet joints or vertebral endplates,
3. decreased disc height by \> 2 mm, but dependent upon the spinal level,
4. scarring/thickening of ligamentum flavum, annulus fibrosis or facet joint capsule,
5. disc degeneration and/or herniation,
6. facet degeneration,
7. vacuum phenomenon.
4. Patients with an Oswestry Disability Index (ODI) score ≥ 35.
5. Patients with a Visual Analogue Scale (VAS) leg score ≥ 40.
6. 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.
7. Patients willing to undergo PK sampling.
Exclusion Criteria
2. Patient requiring emergency spinal decompression or spinal fusion.
3. Patients requiring multilevel fusion or expected to need secondary intervention within one year following surgery.
4. Any prior fusion or attempted fusion at an adjacent level.
5. Any prior fusion or attempted fusion at the index level.
6. Pregnant or breast-feeding women.
7. Known or suspected allergies to any of the components of KUR-113 Bone Graft (e.g.
hypersensitivity to aprotinin).
8. Any prior use of teriparatide or abaloparatide or graft material containing PTH1-34.
9. Patients with hypercalcemic disorders (e.g., primary hyperparathyroidism).
10. Patients with Paget's Disease or unexplained high levels of alkaline phosphatase.
11. Prior radiation therapy involving bone.
12. 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.
13. Any medical condition requiring radiotherapy or immunosuppression.
14. History of thyroid autoimmune disease (Hashimoto's thyroiditis, Graves' disease) or hyperthyroidism.
15. Patients on chronic systemic steroids (i.e. \> 14 consecutive days) within 6 months prior to Screening Visit.
16. Osteopenia (T score \< -1.0) or osteoporosis of the spine (T score \< -2.5).
17. DDD related to benign or malignant tumor.
18. History or presence of active malignancy.
19. Hereditary disorders predisposing to osteosarcoma.
20. Patients with invasive skin cancer.
21. Evidence of local or systemic infection.
22. Patients with known active COVID-19 disease.
23. Current smokers.
24. Type 1 diabetes (regardless of HbA1c) or Type 2 diabetes with a documented HbA1c \> 7.0.
25. Any acute or chronic concurrent medical conditions that in the Investigator's opinion are a contraindication to the procedure and study participation.
26. 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).
27. 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.
28. Involved in active litigation relating to his/her spinal condition or workers compensation claimants.
29. BMI greater than 40.
25 Years
75 Years
ALL
No
Sponsors
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Avania
INDUSTRY
Kuros BioSciences B.V.
INDUSTRY
Kuros Biosurgery AG
INDUSTRY
Responsible Party
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Principal Investigators
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John Chi, MD
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Locations
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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
Countries
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Other Identifiers
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KUR-113/01
Identifier Type: -
Identifier Source: org_study_id
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