INTRACEPT: Prospective, Randomized, Multi-center Study Intraosseous Basivertebral Nerve Ablation for Treatment of CLBP
Prospective, open-label, 1:1 randomized controlled trial of Basivertebral nerve (BVN)
Ablation arm vs Standard Care Control for the treatment of vertebrogenic chronic low back
pain (CLBP). Participants in the the BVN Ablation arm will receive radiofrequency ablation of
the BVN using the Intracept procedure for treatment of up to 4 vertebral bodies (L3 to S1).
Participants in the Standard Care Control arm will continue on non-surgical standard care and
will be offered optional crossover after 12 months of follow-up with follow-up of 6 months
post crossover treatment.
The study had a pre-specified Interim Analysis with stopping rules for superiority when
approximately 60% of the randomized participants have completed their 3-month primary
endpoint study visit. An independent Data Safety Management Board (DSMB) reviewed the interim
analysis results and recommended stopping enrollments for superiority and offering early
crossover to the control arm participants.
– Skeletally mature subjects at least 25 years of age
– Chronic lower back pain for at least 6 months
– Failure to respond to at least 6 months of non-operative conservative management
– Radicular pain
– Current or history of spinal infection
– Modic changes at vertebral bodies other than L3 to S1
– Contraindication to MRI
– Pregnant, lactating or plan to become pregnant in next year
– Has life expectancy of less than 2 years
– Compensated injuries or ongoing litigation regarding back pain/injury, or financial
incentive to remain impaired
Active, not recruiting
AMG0103 in Subjects With Chronic Discogenic Lumbar Back Pain
This clinical trial evaluate the safety, tolerability and exploratory efficacy of targeted
single injection of AMG0103 in subject with chronic discogenic lumbar back pain
1. Male or female, between 18 and 75 years of age, inclusive, and skeletally mature, in
the opinion of the investigator.
2. Has provided written informed consent before undergoing any study-specific procedures.
3. Has chronic low back pain for at least 6 months, where back pain is greater than leg
4. Has separate low back pain and leg pain VAS scores within the following parameters:
1. Average low back pain VAS score of at least 40 mm and less than 90 mm on a 100 mm
visual analog scale.
2. Average leg pain VAS score that is less than or equal to 50% of the average low
back pain VAS score above, where leg pain VAS scores are measured on a 100 mm
visual analog scale.
5. Has had inadequate response to conservative medical care over a period of at least 3
6. Diagnosis of painful degenerative disc disease at one lumbar level from L1 to S1
confirmed by subject history and radiographic studies (eg, MRI, x-rays). Radiographic
studies must demonstrate the following:
1. A Pfirrmann score of 3 or 4 on MRI in just a single disc between L1 and S1
2. With or without contained disc herniations of <3 mm protrusion with no
radiographic evidence of neurologic compression
3. Disc height loss of the symptomatic disc is less than 50% of the adjacent discs
4. All discs other than the index disc must have a Pfirrman score of less than 3
5. No spondylolisthesis or instability on flexion/extension views of more than 1-2
6. No evidence of sacroiliac, or extra-spinal, pathology that could account for
lumbar back pain
7. No more fluid in, or widening of, the facet joints around the symptomatic disc
than is seen on the other facet joints of "normal" levels
7. Has a Body Mass Index (BMI) between 15.0 and 35.0 kg/m2 at the screening visit.
8. Oswestry Disability Index score of at least 30 and not more than 90 on the 100 point
9. Willing and able to comply with all protocol requirements.
10. Females of childbearing potential must agree to use highly effective methods of
contraception during heterosexual intercourse from the date they sign the ICF until 1
year after the single dose of study drug is administered.
11. Male subjects must agree that, if their partner is of childbearing potential, they and
the partner will use an appropriate method of contraception as defined above.
1. Has any prior or current medical condition (eg, an active systemic infection),
including known bleeding disorders that, in the judgment of the Investigator, would
prevent the subject from safely participating in and/or completing all study
2. Has any clinically significant finding on a screening evaluation that in the judgment
of the Investigator would preclude safe study completion.
3. Liver function tests >1.5 the upper limit of normal (ULN) for alkaline phosphatase,
alanine aminotransferase (ALT), aspartate aminotransferase (AST)
4. Serum creatinine >1.5 ULN at screening
5. Blood pressure >160/110 mm Hg recorded on 3 readings at screening and/or resting pulse
>120 beats/min at screening
6. Body temperature ≥101°F on day of planned injection
7. Has a co-morbid medical condition of the spine or the upper extremities that may
affect neurological and/or pain assessments as specified in the protocol, including
spinal fusion, spondylolysis and spondylolisthesis.
8. Has evidence of hip pathology based on clinical history, physical exam and/or
radiographic imaging that could be the source of lumbar back pain.
9. Has a history of an endocrine or metabolic disorder that affects the spine (eg,
10. Has a compressive pathology due to stenosis or frankly herniated disc or sequestered
11. Has symptomatic involvement of more than one lumbar disc, in the opinion of the
12. Has an intact disc bulge/protrusion or focal herniation at the symptomatic level >3
mm, the presence of disc extrusion or sequestration, or a complete annular tear.
13. Has lumbar intervertebral foraminal stenosis at the symptomatic level resulting in
clinically significant spinal nerve root compression, in the opinion of the
14. Has undergone a previous surgery at the symptomatic disc, or has plans to do so within
6 months of receiving the dose of AMG0103, that has altered the structure of the
target disc level, or is likely to do so (eg, laminectomy, foraminotomy, fusion,
intradiscal electrothermal therapy, intradiscal radiofrequency, thermocoagulation).
15. Has had any lumbar intradiscal injection procedure (eg, injection of corticosteroids,
methylene blue, dextrose, or glucosamine and chondroitin sulfate). Discography may be
performed, but must be done at least 3 weeks (or more) prior to the injection
procedure in this study.
16. Has had any epidural steroid injection(s) within 3 months prior to study treatment.
17. Is a female who is pregnant, planning to become pregnant, or lactating.
18. Has a PT(INR) and/or aPTT lab result outside of the reference range, or within the
last 30 days taken, or is currently on, an anticoagulant therapy (e.g., Warfarin) for
the purpose of treating or preventing blood clots.
19. Has ferromagnetic implants that would disallow MRI of the symptomatic disc.
20. Is involved in current or pending spinal litigation where permanent disability
benefits are being sought.
21. Has a physical or mental condition (eg, senile dementia, Alzheimer’s disease) that
would interfere with Subject self-assessment of function, pain or quality of life.
22. Has a positive screen for Hepatitis B Surface Antigen, Hepatitis C antibodies, or
human immunodeficiency virus (HIV) by antibodies or nucleic acid test.
23. Is an immediate family member (by birth) of any other subject participating in this
24. Has a history of cancer that does NOT have documentation to support a complete and
25. Has participated within the previous 3 months in an interventional clinical study or
is concurrently enrolled in any non-interventional research of any type judged to be
scientifically or medically incompatible with this study.
26. Is transient or has been treated in the 6 months prior to providing informed consent
for alcohol and/or drug abuse in an inpatient substance abuse program.
27. Is currently incarcerated (a prisoner).
28. Is an Investigator-site employee or immediate family (defined as a spouse, parent,
child, or sibling, whether biological or legally adopted) of an Investigator-site
29. Is a Sponsor employee (permanent, temporary contract worker, or designee responsible
for the conduct of the study) or immediate family (defined as a spouse, parent, child,
or sibling, whether biological or legally adopted) of a Sponsor employee.
Active, not recruiting
Study to Evaluate the Safety and Preliminary Efficacy of IDCT, a Treatment for Symptomatic Lumbar Intervertebral Disc Degeneration
The purpose of this study is to compare the safety and preliminary efficacy of intradiscal
injections of two doses of IDCT (Discogenic Cells + Sodium Hyaluronate vehicle) and two
controls (saline, Sodium Hyaluronate vehicle) in subjects with chronic low back pain due to
Degenerative Disc Disease (DDD) at one lumbar level from L3 to S1.
Inclusion Criteria: The subject must have:
1. Diagnosis of early to moderate degenerative disc disease (DDD), Modified Pfirrmann
2. Chronic low-back pain for at least 6 months prior to screening; unresponsive to at
least 3 months of conservative care.
3. Low-back pain of 40 to 90 mm on the VAS and ODI score of 30 to 90.
Exclusion Criteria: The subject is excluded if he/she has:
1. Symptomatic involvement of more than one lumbar disc.
2. Other persistent pain/nerve issues including, for example, radiculopathy, leg pain,
cauda equine syndrome, etc.
3. Fracture of the spine, previous lumbar spine surgery or previous treatment of the
4. Evidence of dynamic instability on lumbar flexion-extension radiographs.
5. Grade 2 or higher spondylolisthesis at the target disc, lumbar spondylitis or other
undifferentiated spondyloarthropathy, or Type III Modic changes around the target
6. Clinical suspicion of a full thickness annular tear at the target disc or other
abnormal disc morphology.
7. Clinical suspicion of facet pain as primary pain generator.
8. Subjects who test positive for communicable disease, have significant systemic
disease, or are prone to infection.
9. Patients who are deemed unsuitable for clinical study participation by the
Active, not recruiting
DuraSeal Exact Spine Sealant System Post-Approval Study
This is a non-randomized, post-approval study to further evaluate the rate of post-operative
Cerebral Spinal Fluid (CSF) leaks in subjects who undergo a spinal procedure and receive
DuraSeal Exact Spine Sealant System.
– Subject is 18 years of age or older
– Subject had a spinal procedure where a dural opening (either intentional or
incidental) occurred and was treated with either:
– DuraSeal™ Exact Spine Sealant (DuraSeal™ Sealant group ONLY) OR
– Any other method of sealing the dura with the exception of DuraSeal™ Sealant
-either spinal or cranial. (Control group ONLY)
– Subject, or authorized representative, has been informed of the nature of the study
and has provided written informed consent approved by the appropriate Institutional
Review Board (IRB) of the respective clinical site prior to the collection of study
– Prospective subjects: Consent must be obtained within 24 hours of surgery stop
– Retrospective subjects (Control group specific): IRB approval may be granted to
individual sites to waive requirement for informed consent.
– The investigator determines that the subject will not be able to comply with the
required follow-up visits (not required if subject is being enrolled retrospectively-
control group ONLY)
– Pregnant or breastfeeding females (as documented in the medical records; no testing
beyond the site’s standard of care is required)
Prospective Study of Safety and Efficacy of InQu® Bone Graft Extender in Lumbar Interbody Fusion Surgery
The purpose of this study is to collect on-label safety and efficacy data where InQu Bone
Graft Extender is applied to transforaminal lumbar interbody fusion (TLIF) and posterior
lumbar interbody fusion (PLIF).
It is expected that this study will contribute to the compilation of clinical data required
to demonstrate the ability of InQu to promote safe, effective and timely spine fusion in
patients who undergo PLIF or TLIF surgery. The results of this study will lead to further
analysis (i.e. comparison to historical data of other marketed bone graft products, as well
as, to local bone alone).
– A subject may be included if s/he meets the following criteria:
1. ≥18 years of age;
2. Able to give appropriate informed consent;
3. Willing and able to meet the proposed follow-up schedule;
4. Has documented diagnosis of up to, and including, Grade 1 spondylolisthesis
and/or degenerative disc disease;
5. Has given appropriate consent for, and undergoes, standard-of-care transforminal
or posterior lumber interbody fusion;
6. Use of InQu Bone Graft Extender on-label.
1. Any prior lumbar fusion surgery;
2. Requires fusion surgery of more than two adjacent levels;
3. Has fusion surgery requiring titanium cages;
4. Has a systemic infection or has infection at the site of surgery;
5. Has a medical condition or requires post-operative medication that, in the opinion of
the investigator, may interfere with bony/soft tissue healing;
6. Has any physical, social, psychological or economic condition that, in the opinion of
the investigator, may preclude accurate data collection or evaluation.
The INSPIRE Study: Probable Benefit of the Neuro-Spinal Scaffold for Treatment of AIS A Thoracic Acute Spinal Cord Injury
This is an HDE probable benefit, open-label, non- randomized, single-arm, multicenter study
to evaluate the safety and probable benefit of the poly(lactic-co-glycolic
acid)-b-poly(L-lysine) Scaffold (“Scaffold”) in subjects with thoracic AIS A traumatic spinal
cord injury at neurological level of injury of T2-T12.
Subjects must meet all of the following to be considered eligible:
1. AIS A classification of traumatic spinal cord injury at T2-T12 neurological level of
injury confirmed by a qualified medical professional
2. Recent injury (must receive Scaffold within 7 days from injury)
3. Non-penetrating SCI (contusion injury) that is no less than approximately 4 mm in
diameter by MRI
4. Requires open spine surgery allowing access to the injured spinal cord (subjects
requiring either posterior surgical approach or posterior plus anterior approach will
5. Informed consent obtained
6. 16-70 years of age, inclusive
7. Hemodynamically stable and deemed a suitable candidate for surgery
Subjects who meet any of the following will be excluded:
1. Terminally ill subjects not likely to be able to participate in follow-up
2. Incomplete spinal cord injury (AIS B, C, D, and E injuries)
3. Subjects with more than one discrete spinal cord injury (contusion) will be excluded.
4. No discrete cavity (existing or created by irrigation/myelotomy) in the contused
spinal cord in which a Scaffold can be placed
5. Evidence of clear and significant Somatosensory Evoked Potentials (SSEP) transmission
through the injury site before Scaffold implantation (based on the judgment of the
6. Subjects with clinically significant pre-existing neurological comorbidities that are
unrelated to the contusion being treated (e.g., multiple sclerosis, amyotrophic
lateral sclerosis, significant prior peripheral nerve dysfunction, residual problems
related to previous spine-related neurological pathologies) will be excluded only if
it is felt that these preexisting morbidities will increase risk, affect safety
monitoring, or confound study results
7. Spinal cord injury associated with significant traumatic brain injury or coma that, in
the opinion of the Investigator, would preclude adequate assessment of spinal cord
function, brain injury that could be associated on its own with sensory or motor
deficits, or subjects with any other reason that results in an unreliable
International Standards of Neurological Classification of Spinal Cord Injury (ISNCSCI)
8. Subjects with clinically significant pre-existing respiratory disease not related to
the contusion being treated (e.g., chronic obstructive pulmonary disorder)
9. Subjects requiring Long-term ongoing mechanical ventilation
10. Subjects with documented immune deficiency disorders, including a known diagnosis of
11. Recent (according to Diagnostic and Statistical Manual of Mental Disorders (DSM) IV or
DSM V criteria) history of abuse of narcotics or other significant substance abuse
12. Significant injury complications where, in the view of the Investigator, participation
in the study could further complicate subject care, limit study follow-up, or confound
interpretation of safety or efficacy data.
13. A female who is:
– Pregnant, or planning to become pregnant within the next 12-months; or
– Breastfeeding; or
– A woman of child-bearing potential (defined as post menarche and biologically
capable of becoming pregnant [i.e., not surgically sterile]) who is engaged in
active heterosexual relations and is not willing to use a barrier or hormonal
form of birth control for 12-months following Scaffold implantation (e.g., oral,
injected, or implanted contraceptives)
14. A male who is engaged in active heterosexual relations and is not willing to use birth
control for 3-months following Scaffold implantation including sperm donation or
15. Current or impending incarceration
16. Complete spinal cord transection
17. Subjects with spinal cord injuries directly due to gunshot, knife, or other
18. Known hypersensitivity to poly(lactic-co-glycolic acid) (PLGA) or poly-L-lysine (PLL)
(e.g., hypersensitivity to absorbable sutures containing PLGA)
19. History of severe mental illness (according to DSM IV or V)
20. Evidence of pre-trauma active local or systemic infection
21. Participation in another interventional clinical trial for six months after Scaffold
22. Body mass index (BMI) over 39
23. Having a medical condition (e.g., cardiovascular disease, life threatening injuries),
or receiving medical treatment, or having any other reason that, in the judgment of
the Investigator, precludes successful participation and follow-up for at least six
months or confounds collection or interpretation of study safety, feasibility, or
Active, not recruiting
Safety and Efficacy of SA4Ag Vaccine in Adults Having Elective Open Posterior Spinal Fusion Procedures With Multilevel Instrumentation
The purposes of the clinical trial are to determine whether the SA4Ag vaccine can prevent
postoperative Staphylococcus aureus infections in patients who are undergoing elective spinal
fusion surgery, and to evaluate the safety of SA4Ag in patients who are undergoing elective
– Subject must be scheduled to undergo an elective open posterior spinal fusion
procedures with multilevel instrumentation, 10 to 60 days after study vaccination.
– Subject must be available for the entire duration of the study, and able to comply
with scheduled visits, treatment plan, laboratory tests, and other study procedures
including completion of the electronic diary for 10 days after study vaccination.
– Aged 18 to <86 years old Exclusion Criteria: - Planned spinal fusion procedure requiring separate operations performed on separate days (ie, staged procedure). - Surgical indication of malignancy, infection or acute or emergency trauma. - History of major surgery within 3 months prior to enrollment, or anticipated major surgery other than the Index Surgical Procedure between study enrollment and completion of study participation. - History of any spinal surgery performed within 6 months prior to study enrollment. - History of any previous spinal surgery resulting in postoperative BSI or SSI. - Congenital or acquired immunodeficiency disorder, rheumatologic disorder or other illness requiring chronic treatment with known immunosuppressant medications, including monoclonal antibodies within a year of enrollment or the use of systemic corticosteroids for > 14 days within 30 days prior to enrollment.
– History of leukemia, lymphoma, underlying bone marrow disorder or history of bone
Dose Escalation Study of AST-OPC1 in Spinal Cord Injury
The purpose of this study is to evaluate the safety of cross sequential escalating doses of
AST-OPC1 administered among 5 cohorts at a single time-point between 21 and 42 days post
injury, inclusively, to subjects with subacute cervical spinal cord injuries (SCI).
Major Inclusion Criteria:
– Sensorimotor complete, traumatic SCI (ASIA Impairment Scale A) for cohorts 1,2,3
– Sensorimotor incomplete, traumatic SCI (ASIA Impairment Scale B) for cohorts 4,5
– Last fully preserved single neurological level (SNL) from C-4 to C-7
– From 18 through 69 years of age at time of injury
– Single spinal cord lesion on a post-stabilization magnetic resonance imaging (MRI)
scan, with sufficient visualization of the spinal cord injury epicenter and lesion
margins to enable post-injection safety monitoring
– Informed consent for this protocol and the companion long term follow-up protocol must
be provided and documented (i.e., signed informed consent forms) no later than 37 days
– Able to participate in an elective surgical procedure to inject AST-OPC1 21-42 days
Major Exclusion Criteria:
– SCI due to penetrating trauma
– Traumatic anatomical transection or laceration of the spinal cord based on prior
surgery or MRI
– Any concomitant injury that interferes with the performance, interpretation or
validity of neurological examinations
– Inability to communicate effectively with neurological examiner such that the validity
of patient data could be compromised
– Significant organ damage or systemic disease that would create an unacceptable risk
for surgery or immunosuppression
– History of any malignancy (except non-melanoma skin cancers)
– Pregnant or nursing women
– Body mass index (BMI) > 35 or weight > 300 lbs.
– Active participation in another experimental procedure/intervention