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

NCT04294004 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: KUR-113/01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 15

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).

Conditions

Degenerative Disc Disease; Spinal Fusion

Keywords

Spinal Fusion; Posterolateral Fusion; MagnetOs; Fibrin-PTH (KUR-113)

Outcome Measures

Primary Outcomes (1)

• Radiographic interbody fusion

  Evidence of bridging trabeculae or continuous bony connection between superior and inferior vertebral body on CT-scan as determined by an independent radiology expert panel (IREP).

  Month 12 post-surgery

Secondary Outcomes (7)

• Composite Endpoint

  Month 6 and Month 12 post-surgery

• Radiographic interbody fusion

  Month 6 post-surgery

• Radiographic posterolateral fusion

  Month 6 and Month 12 post-surgery

• ODI

  Week 6, Month 3, Month 6, Month 12, and Month 24 post-surgery

• Leg Pain

  Initial discharge from hospital (on average 3 days post-surgery), Week 6, Month 3, Month 6, Month 12, and Month 24 post-surgery

Study Arms (3)

KUR-113, Stage 1

EXPERIMENTAL

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.

Combination Product: TGplPTH1-34 in fibrin

Autologous Bone Graft

ACTIVE COMPARATOR

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.

Other: Autologous Bone Graft

KUR-113, Stage 2

EXPERIMENTAL

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.

Combination Product: TGplPTH1-34 in fibrin

Interventions

TGplPTH1-34 in fibrin COMBINATION_PRODUCT

TGplPTH1-34 within a fibrin matrix applied within and around a polyetheretherketone (PEEK) intervertebral cage

Also known as: KUR-113

KUR-113, Stage 1; KUR-113, Stage 2

Autologous Bone Graft OTHER

Local autograft collected from decompression which may be supplemented with iliac crest bone graft (ICBG) if local autograft is insufficient.

Autologous Bone Graft

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Kuros Biosurgery AG: lead
• Avania: collaborator
• Kuros BioSciences B.V.: collaborator

Study Sites (15)

University of California San Diego

La Jolla, California, 92093-0863, United States

Location

Justin Parker Neurological Institute

Boulder, Colorado, 80303, United States

Location

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

Northwestern University-Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Indiana Spine Group

Carmel, Indiana, 46032, United States

Location

Kansas Spine and Specialty Hospital

Wichita, Kansas, 67226, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Orthopedic Associates of Michigan

Grand Rapids, Michigan, 49525, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

Hospital for Special Surgery

New York, New York, 10021, United States

Location

University at Buffalo Neurosurgery

Williamsville, New York, 14221, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

South Texas Spine Center

San Antonio, Texas, 78240, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Interventions

Fibrin

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• John Chi, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Due to the different technical procedures between the control and the intervention arms (KUR-113 Bone Graft versus local autograft), investigators cannot be blinded to the treatment. However, all stage 1 patients will remain blinded for the duration of their participation in the study. All stage 2 patients will receive the same treatment and will be unblinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2020
• First Posted: March 3, 2020
• Study Start: August 27, 2020
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2025
• Last Updated: August 9, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)