Degenerative Disc DiseasePhase 2STRUCTURENCT04294004
KUR-113 Bone Graft Versus Local Autograft for the Treatment of Single-level Transforaminal Lumbar Interbody Fusion
A Phase 2 study testing TGplPTH1-34 in fibrin and Autologous Bone Graft in people with Degenerative Disc Disease and Spinal Fusion, run by Kuros Biosurgery AG at 15 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Degenerative Disc Disease, Spinal Fusion
- What is being tested?
- TGplPTH1-34 in fibrin and Autologous Bone Graft
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 15 sitesUnited States
- Study dates
- 27 Aug 2020to 30 Jul 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Justin Parker Neurological Institute
Boulder, Colorado, 80303
Indiana Spine Group
Carmel, Indiana, 46032
Northwestern University-Northwestern Memorial Hospital
Chicago, Illinois, 60611
Orthopedic Associates of Michigan
Grand Rapids, Michigan, 49525
University of California San Diego
La Jolla, California, 92093-0863
Hospital for Special Surgery
New York, New York, 10021
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
South Texas Spine Center
San Antonio, Texas, 78240
Washington University in St. Louis
St Louis, Missouri, 63110
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Kansas Spine and Specialty Hospital
Wichita, Kansas, 67226
University at Buffalo Neurosurgery
Williamsville, New York, 14221
About this study
Official title: A Prospective, Randomized and Non-randomized, Controlled, Single-blind and Open-label, 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
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).
Read the 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.
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
- Degenerative Disc Disease, Spinal Fusion
- Being tested
- TGplPTH1-34 in fibrin, Autologous Bone Graft
- Keywords
- Spinal Fusion, Posterolateral Fusion, MagnetOs, Fibrin-PTH (KUR-113)
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TGplPTH1-34 in fibrinCombination product
Also called KUR-113
TGplPTH1-34 within a fibrin matrix applied within and around a polyetheretherketone (PEEK) intervertebral cage
Autologous Bone GraftOther
Local autograft collected from decompression which may be supplemented with iliac crest bone graft (ICBG) if local autograft is insufficient.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Combination Product: TGplPTH1-34 in fibrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Month 12 post-surgery
Secondary outcomes (7)
Composite Endpoint
Radiographic interbody fusion using CT-scans, functional outcome (decrease of 15 points or more on Oswestry Disability Index (ODI)) and no post-surgical intervention to aid fusion or replace any of the spinal implants.
Measured: Month 6 and Month 12 post-surgery
Radiographic interbody fusion
Determined by IREP using CT-scans
Measured: Month 6 post-surgery
Radiographic posterolateral fusion
Determined by IREP using CT-scans
Measured: Month 6 and Month 12 post-surgery
ODI
Change from baseline
Measured: Week 6, Month 3, Month 6, Month 12, and Month 24 post-surgery
Leg Pain
Change from baseline using Visual Analogue Scale (VAS). VAS is scored from 0 to 100 with higher numbers being a worse outcome than a lower number.
Measured: Initial discharge from hospital (on average 3 days post-surgery), Week 6, Month 3, Month 6, Month 12, and Month 24 post-surgery
Back Pain
Change from baseline using Visual Analogue Scale (VAS). VAS is scored from 0 to 100 with higher numbers being a worse outcome than a lower number.
Measured: Initial discharge from hospital (on average 3 days post-surgery), Week 6, Month 3, Month 6, Month 12, and Month 24 post-surgery
Number of Secondary Interventions
Revisions, re-operations, removals, supplemental fixations, or any other procedure that adjusts or in any way removes part of the original implant configuration with or without replacement of the components
Measured: Up to Month 24 post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start27 Aug 2020
- Primary completion30 Jul 2024 (estimated)
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuros Biosurgery AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Avania, Kuros BioSciences B.V.
- Responsible party
- Sponsor
- Investigators
- John Chi, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04294004
- Sponsor's protocol ID
- KUR-113/01
- Acronym
- STRUCTURE
- Status last verified
- Aug 2023
- First submitted
- 25 Feb 2020
- Last updated
- 9 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized and Non-randomized, Controlled, Single-blind and Open-label, 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
- ClinicalTrials.gov ID
- NCT04294004
- Acronym / sponsor ID
- STRUCTURE / KUR-113/01
- Conditions
- Degenerative Disc Disease, Spinal Fusion
- Keywords
- Spinal Fusion, Posterolateral Fusion, MagnetOs, Fibrin-PTH (KUR-113)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Kuros Biosurgery AGIndustry (pharma, biotech, devices)
- Collaborators
- Avania, Kuros BioSciences B.V.
- Study start
- 27 Aug 2020 (actual)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 3 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| KUR-113, Stage 1 | Experimental | Combination Product: TGplPTH1-34 in fibrinDuring 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. |
| Autologous Bone Graft | Active comparator | Other: Autologous Bone GraftDuring 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. |
| KUR-113, Stage 2 | Experimental | Combination Product: TGplPTH1-34 in fibrinDuring 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. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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:
- Patients with an Oswestry Disability Index (ODI) score ≥ 35.
- Patients with a Visual Analogue Scale (VAS) leg score ≥ 40.
Key exclusion criteria (30 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TGplPTH1-34 in fibrinAlso: KUR-113TGplPTH1-34 within a fibrin matrix applied within and around a polyetheretherketone (PEEK) intervertebral cage | Combination product | KUR-113, Stage 1, KUR-113, Stage 2 |
| Autologous Bone GraftLocal autograft collected from decompression which may be supplemented with iliac crest bone graft (ICBG) if local autograft is insufficient. | Other | Autologous Bone Graft |
Primary outcome
Radiographic interbody fusion
Time frame: Month 12 post-surgery
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).
7 secondary outcomes
Composite Endpoint
Time frame: Month 6 and Month 12 post-surgery
Radiographic interbody fusion
Time frame: Month 6 post-surgery
Radiographic posterolateral fusion
Time frame: Month 6 and Month 12 post-surgery
ODI
Time frame: Week 6, Month 3, Month 6, Month 12, and Month 24 post-surgery
Leg Pain
Time frame: Initial discharge from hospital (on average 3 days post-surgery), Week 6, Month 3, Month 6, Month 12, and Month 24 post-surgery
Back Pain
Time frame: Initial discharge from hospital (on average 3 days post-surgery), Week 6, Month 3, Month 6, Month 12, and Month 24 post-surgery
Number of Secondary Interventions
Time frame: Up to Month 24 post-surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Chi, MD principal investigator
Brigham and Women's Hospital
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TGplPTH1-34 in fibrin and Autologous Bone Graft in people with Degenerative Disc Disease and Spinal Fusion, run by Kuros Biosurgery AG at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic interbody fusion (time frame: Month 12 post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2023.