Degenerative Disc DiseaseNCT07775729
Prospective Study of ProteiOS in Lumbar Interbody Fusion (TLIF)
A study testing Allograft-derived growth factor (ProteiOS®) in people with Degenerative Disc Disease and Spinal Stenosis Lumbar, run by Isto Biologics.
Trial summary
This is a prospective, multicenter, randomized, controlled study evaluating Influx™ ProteiOS®, an allograft-derived growth factor product, in transforaminal lumbar interbody fusion (TLIF). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Degenerative Disc Disease, Spinal Stenosis Lumbar, Lumbar Spine Fusion
- What is being tested?
- Allograft-derived growth factor (ProteiOS®)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years, skeletally mature at time of surgery
- Degenerative disease of the lumbar spine (L2-S1) requiring 1-2 level instrumented TLIF, with or without posterolateral fusion, as determined by the treating surgeon
- For the ALIF study site only: degenerative disease of the lumbar spine (L2-S1) requiring 1-2 level instrumented ALIF
- Radiographic evidence of degenerative lumbar disease on CT, MRI, or plain radiograph (decreased disc height, herniated nucleus pulposus, ligamentum flavum/annulus hypertrophy, facet arthrosis/osteophyte, spinal canal or foraminal stenosis, or vertebral translation >3 mm)
- Symptoms of low back pain, radiculopathy, or neurogenic claudication consistent with radiographic findings
- Preoperative back pain ≥4 on a 0-10 VAS
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- Preoperative leg pain ≥3 on a 0-10 VAS, consistent with radiculopathy or neurogenic claudication
- Preoperative ODI score ≥30
- Failure of ≥6 months non-operative treatment (may be waived for progressive neurological deficit, new/worsening motor weakness, bowel/bladder dysfunction, or cauda equina syndrome)
- Willing and able to comply with follow-up schedule and provide written informed consent
Who cannot join
- Scheduled for surgery with synthetic bone grafts containing hydroxyapatite, tricalcium phosphate, or other radio-opaque material
- BMI >40
- Prior lumbar spine fusion surgery at a level currently scheduled for surgery
- Malignancy or treatment for malignancy within the last 5 years (benign skin cancer permitted)
- Osteoporosis/osteopenia (≤2.5 SD below age-matched mean)
- Use of rhBMP-2 (Infuse) or other active biologics
Show all 11Show fewer
- Active or systemic infection, malignancy, or severe metabolic bone disease
- Chronic steroid use (>10 days)
- Revision fusion at index levels
- Participation in another interventional clinical study within 30 days of consent
- Known pregnancy or intent to become pregnant during the study
About this study
Official title: Prospective, Multicenter Evaluation of ProteiOS® Allograft Derived Growth Factor in Transforaminal Lumbar Interbody Fusion (TLIF)
This is a prospective, multicenter, randomized, controlled study evaluating Influx™ ProteiOS®, an allograft-derived growth factor product, in transforaminal lumbar interbody fusion (TLIF). Participants undergoing 1- to 2-level TLIF (L2-S1) are randomized 2:1 to receive ProteiOS or a control graft (local bone with optional cancellous chip augmentation, no ProteiOS). The primary objective is to determine whether the 12-month interbody fusion rate (assessed by CT using the Brantigan-Steffee-Fraser classification) with ProteiOS is non-inferior to control, using a 5-percentage-point non-inferiority margin. Patient-reported outcomes (ODI, VAS, EQ-5D-5L), safety, and healthcare utilization are also assessed. A separate exploratory cohort at one study site will evaluate the same outcomes in participants undergoing anterior lumbar interbody fusion (ALIF) with or without ProteiOS, without formal hypothesis testing.
Read the detailed description
Transforaminal lumbar interbody fusion (TLIF) is a widely used technique for degenerative lumbar spine pathology. Prospective, randomized evidence on fusion outcomes, patient-reported outcomes, safety, and healthcare utilization for ProteiOS in TLIF is currently limited to retrospective data. This study randomizes participants 2:1 to ProteiOS versus a within-category control (standard graft material, no ProteiOS), with central, blinded, independent radiographic review of CT and X-ray fusion outcomes. The primary endpoint is CT-confirmed interbody fusion (BSF-3) at 12 months, tested for non-inferiority (margin = 5 percentage points, assumed fusion rates 95% ProteiOS vs. 89% control, 80% power, one-sided α = 0.025, Farrington-Manning likelihood score method). Secondary endpoints include fusion at 6 and 24 months, X-ray-based interbody and posterolateral fusion assessment (Lenke classification for PLF), patient-reported outcomes at 3, 6, and 24 months, adverse events, and healthcare utilization
- Conditions
- Degenerative Disc Disease, Spinal Stenosis Lumbar, Lumbar Spine Fusion, Spondylolisthesis, Spinal Stenosis, Lumbar Region, Transforaminal Lumbar Interbody Fusion
- Being tested
- Allograft-derived growth factor (ProteiOS®), Standard of Care (SOC)
- Keywords
- ProteiOS, HCT/P, bone graft, spinal fusion, lumbar interbody fusion, growth factor, allograft, TLIF
- Medical subject headings
- Intervertebral Disc Degeneration, Spondylolisthesis, Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allograft-derived growth factor (ProteiOS®)Other
Allograft-derived growth factor product (ProteiOS®) containing endogenous osteoinductive, angiogenic, and chemoattractant proteins bound to a scaffold of choice
Standard of Care (SOC)Other
Local autograft with optional mineralized cancellous allograft chip augmentation
| Study group | Role | What they receive |
|---|---|---|
| TLIF - ProteiOS (Treatment) | Experimental | Influx™ demineralized cortical fibers combined 1:1 with ProteiOS®, ≥50% of total graft volume per level (5-15 cc total), optional cancellous allograft chip augmentation. If PLF indicated: 100% cortical fiber graft + ProteiOS + local bone in Fibrant PAK containment bag. Receives: Other: Allograft-derived growth factor (ProteiOS®) |
| TLIF - Control | Active comparator | 5-15 cc locally harvested autograft, optional mineralized cancellous allograft chip augmentation, no ProteiOS. If PLF indicated: cortical fiber graft + local bone in Fibrant PAK containment bag. Receives: Other: Standard of Care (SOC) |
| ALIF - ProteiOS (Treatment) | Experimental | Same ProteiOS-based mixture as TLIF treatment arm Receives: Other: Allograft-derived growth factor (ProteiOS®) |
| ALIF - Control | Active comparator | Same control graft composition as TLIF control arm Receives: Other: Standard of Care (SOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Fusion Success (via Computed Tomography (CT) analysis)
Percentage of participants achieving fusion success, defined as Brantigan-Steffee-Fraser (BSF) classification Grade 3 (solid fusion: trabecular bone bridging across ≥50% of the interbody fusion area) at the treated level(s), assessed by CT scan. BSF is a 3-grade classification ranging from Grade 1 (pseudarthrosis) to Grade 3 (solid fusion), with higher grade indicating better fusion status.
Measured: 12 months
Patient Reported Outcome: Oswestry Disability Index (ODI)
Oswestry Disability Index (ODI), a 10-item questionnaire assessing functional disability due to low back pain (raw score converted to a percentage, range 0-100%; 0 = no disability, 100 = maximum disability; higher score = worse disability), assessed at 12 months; mean scores compared between treatment and control arms.
Measured: 12 Months
Patient Reported Outcome: Neurological
Neurological status: Percentage of participants with no new or worsening neurological deficit from baseline, assessed across three components: motor function (Medical Research Council [MRC] grading scale, range 0-5, higher score indicates greater strength), sensory function (graded as intact, diminished, or absent), and deep tendon reflexes (graded as absent, diminished, normal, or hyperreflexic).
Measured: 12 Months
Patient Reported Outcome: Visual Analog Scale (VAS)
Visual Analog Scale (VAS) for leg and back pain (range 0-10; 0 = no pain, 10 = worst pain imaginable; higher score = worse pain), assessed at 12 months; mean scores compared between treatment and control arms.
Measured: 12 Months
Secondary outcomes (9)
Fusion (via Computed Tomography (CT))
Percentage of participants achieving fusion success, defined as Brantigan-Steffee-Fraser (BSF) classification Grade 3 (solid fusion: trabecular bone bridging across ≥50% of the interbody fusion area) at the treated level(s), assessed by CT scan. BSF is a 3-grade classification ranging from Grade 1 (pseudarthrosis) to Grade 3 (solid fusion), with higher grade indicating better fusion status.
Measured: 6 and 24 months
Fusion (x ray)
Percentage of participants achieving fusion by X-ray. Interbody fusion (all participants): Brantigan-Steffee-Fraser (BSF) classification, Grade 1 (pseudarthrosis) to Grade 3 (solid fusion); success = Grade 3; higher grade = better.
Measured: 3, 6, 12, 24 months
Adverse Events
Nature (descriptive) and frequency (number) of procedure and biologic related Adverse Events and Serious Adverse Events
Measured: 24 months
Patient Reported Outcome: Visual Analog Scale (VAS)
Visual Analog Scale (VAS) for leg and back pain (range 0-10; 0 = no pain, 10 = worst pain imaginable; higher score = worse pain); mean scores compared between treatment and control arms.
Measured: 3, 6, 24 Months
Patient Reported Outcome: Neurological
Neurological status: Percentage of participants with no new or worsening neurological deficit from baseline, assessed across three components: motor function (Medical Research Council [MRC] grading scale, range 0-5, higher score indicates greater strength), sensory function (graded as intact, diminished, or absent), and deep tendon reflexes (graded as absent, diminished, normal, or hyperreflexic).
Measured: 3, 6, 24 Months
Patient Reported Outcome: Oswestry Disability Index (ODI)
Oswestry Disability Index (ODI), a 10-item questionnaire assessing functional disability due to low back pain (raw score converted to a percentage, range 0-100%; 0 = no disability, 100 = maximum disability; higher score = worse disability); mean scores compared between treatment and control arms.
Measured: 3, 6, 24 Months
Healthcare utilization: Frequency of Hospital Visits
Number of hospital visits per participant, up to 24 months.
Measured: Up to 24 months
Healthcare Utilization: Length of Hospital Stay
Duration of hospital stay per participant, in days, up to 24 months.
Measured: Up to 24 months
Healthcare Utilization: ICU Time
Duration of ICU stay per participant, in days, up to 24 months.
Measured: Up to 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study startDec 2026 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionJan 2030 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2:1 randomization to ProteiOS (treatment) vs. control within each of two surgical cohorts (TLIF, ALIF)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Isto Biologics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07775729
- Sponsor's protocol ID
- CS-07
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter Evaluation of ProteiOS® Allograft Derived Growth Factor in Transforaminal Lumbar Interbody Fusion (TLIF)
- ClinicalTrials.gov ID
- NCT07775729
- Acronym / sponsor ID
- CS-07
- Conditions
- Degenerative Disc Disease, Spinal Stenosis Lumbar, Lumbar Spine Fusion, Spondylolisthesis, Spinal Stenosis, Lumbar Region, Transforaminal Lumbar Interbody Fusion
- Keywords
- ProteiOS, HCT/P, bone graft, spinal fusion, lumbar interbody fusion, growth factor, allograft, TLIF
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Isto BiologicsIndustry (pharma, biotech, devices)
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 20 Aug 2026 (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.
This is a prospective, multicenter, randomized, controlled study evaluating Influx™ ProteiOS®, an allograft-derived growth factor product, in transforaminal lumbar interbody fusion (TLIF). Participants undergoing 1- to 2-level TLIF (L2-S1) are randomized 2:1 to receive ProteiOS or a control graft (local bone with optional cancellous chip augmentation, no ProteiOS). The primary objective is to determine whether the 12-month interbody fusion rate (assessed by CT using the Brantigan-Steffee-Fraser classification) with ProteiOS is non-inferior to control, using a 5-percentage-point non-inferiority margin. Patient-reported outcomes (ODI, VAS, EQ-5D-5L), safety, and healthcare utilization are also assessed. A separate exploratory cohort at one study site will evaluate the same outcomes in participants undergoing anterior lumbar interbody fusion (ALIF) with or without ProteiOS, without formal hypothesis testing.
Detailed description
Transforaminal lumbar interbody fusion (TLIF) is a widely used technique for degenerative lumbar spine pathology. Prospective, randomized evidence on fusion outcomes, patient-reported outcomes, safety, and healthcare utilization for ProteiOS in TLIF is currently limited to retrospective data. This study randomizes participants 2:1 to ProteiOS versus a within-category control (standard graft material, no ProteiOS), with central, blinded, independent radiographic review of CT and X-ray fusion outcomes. The primary endpoint is CT-confirmed interbody fusion (BSF-3) at 12 months, tested for non-inferiority (margin = 5 percentage points, assumed fusion rates 95% ProteiOS vs. 89% control, 80% power, one-sided α = 0.025, Farrington-Manning likelihood score method). Secondary endpoints include fusion at 6 and 24 months, X-ray-based interbody and posterolateral fusion assessment (Lenke classification for PLF), patient-reported outcomes at 3, 6, and 24 months, adverse events, and healthcare utilization
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- 2:1 randomization to ProteiOS (treatment) vs. control within each of two surgical cohorts (TLIF, ALIF)
| Arm | Type | Receives |
|---|---|---|
| TLIF - ProteiOS (Treatment) | Experimental | Other: Allograft-derived growth factor (ProteiOS®)Influx™ demineralized cortical fibers combined 1:1 with ProteiOS®, ≥50% of total graft volume per level (5-15 cc total), optional cancellous allograft chip augmentation. If PLF indicated: 100% cortical fiber graft + ProteiOS + local bone in Fibrant PAK containment bag. |
| TLIF - Control | Active comparator | Other: Standard of Care (SOC)5-15 cc locally harvested autograft, optional mineralized cancellous allograft chip augmentation, no ProteiOS. If PLF indicated: cortical fiber graft + local bone in Fibrant PAK containment bag. |
| ALIF - ProteiOS (Treatment) | Experimental | Other: Allograft-derived growth factor (ProteiOS®)Same ProteiOS-based mixture as TLIF treatment arm |
| ALIF - Control | Active comparator | Other: Standard of Care (SOC)Same control graft composition as TLIF control arm |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18-75 years, skeletally mature at time of surgery
- Degenerative disease of the lumbar spine (L2-S1) requiring 1-2 level instrumented TLIF, with or without posterolateral fusion, as determined by the treating surgeon
- For the ALIF study site only: degenerative disease of the lumbar spine (L2-S1) requiring 1-2 level instrumented ALIF
- Radiographic evidence of degenerative lumbar disease on CT, MRI, or plain radiograph (decreased disc height, herniated nucleus pulposus, ligamentum flavum/annulus hypertrophy, facet arthrosis/osteophyte, spinal canal or foraminal stenosis, or vertebral translation >3 mm)
- Symptoms of low back pain, radiculopathy, or neurogenic claudication consistent with radiographic findings
Key exclusion criteria (11 listed)
- Scheduled for surgery with synthetic bone grafts containing hydroxyapatite, tricalcium phosphate, or other radio-opaque material
- BMI >40
- Prior lumbar spine fusion surgery at a level currently scheduled for surgery
- Malignancy or treatment for malignancy within the last 5 years (benign skin cancer permitted)
- Osteoporosis/osteopenia (≤2.5 SD below age-matched mean)
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 |
|---|---|---|
| Allograft-derived growth factor (ProteiOS®)Allograft-derived growth factor product (ProteiOS®) containing endogenous osteoinductive, angiogenic, and chemoattractant proteins bound to a scaffold of choice | Other | ALIF - ProteiOS (Treatment), TLIF - ProteiOS (Treatment) |
| Standard of Care (SOC)Local autograft with optional mineralized cancellous allograft chip augmentation | Other | ALIF - Control, TLIF - Control |
Primary outcome
Rate of Fusion Success (via Computed Tomography (CT) analysis)
Time frame: 12 months
Percentage of participants achieving fusion success, defined as Brantigan-Steffee-Fraser (BSF) classification Grade 3 (solid fusion: trabecular bone bridging across ≥50% of the interbody fusion area) at the treated level(s), assessed by CT scan. BSF is a 3-grade classification ranging from Grade 1 (pseudarthrosis) to Grade 3 (solid fusion), with higher grade indicating better fusion status.
Patient Reported Outcome: Oswestry Disability Index (ODI)
Time frame: 12 Months
Oswestry Disability Index (ODI), a 10-item questionnaire assessing functional disability due to low back pain (raw score converted to a percentage, range 0-100%; 0 = no disability, 100 = maximum disability; higher score = worse disability), assessed at 12 months; mean scores compared between treatment and control arms.
Patient Reported Outcome: Neurological
Time frame: 12 Months
Neurological status: Percentage of participants with no new or worsening neurological deficit from baseline, assessed across three components: motor function (Medical Research Council [MRC] grading scale, range 0-5, higher score indicates greater strength), sensory function (graded as intact, diminished, or absent), and deep tendon reflexes (graded as absent, diminished, normal, or hyperreflexic).
Patient Reported Outcome: Visual Analog Scale (VAS)
Time frame: 12 Months
Visual Analog Scale (VAS) for leg and back pain (range 0-10; 0 = no pain, 10 = worst pain imaginable; higher score = worse pain), assessed at 12 months; mean scores compared between treatment and control arms.
9 secondary outcomes
Fusion (via Computed Tomography (CT))
Time frame: 6 and 24 months
Fusion (x ray)
Time frame: 3, 6, 12, 24 months
Adverse Events
Time frame: 24 months
Patient Reported Outcome: Visual Analog Scale (VAS)
Time frame: 3, 6, 24 Months
Patient Reported Outcome: Neurological
Time frame: 3, 6, 24 Months
Patient Reported Outcome: Oswestry Disability Index (ODI)
Time frame: 3, 6, 24 Months
Healthcare utilization: Frequency of Hospital Visits
Time frame: Up to 24 months
Healthcare Utilization: Length of Hospital Stay
Time frame: Up to 24 months
Healthcare Utilization: ICU Time
Time frame: Up to 24 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Allograft-derived growth factor (ProteiOS®) in people with Degenerative Disc Disease and Spinal Stenosis Lumbar, run by Isto Biologics.
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 10 inclusion and 11 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: opening soon, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Rate of Fusion Success (via Computed Tomography (CT) analysis) (time frame: 12 months). The study lists 4 primary outcomes in all. 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 20 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.