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.

For information about this clinical trial here at USC or to see if you qualify, contact us by phone at (800) USC-CARE for more information.

Inclusion Criteria:

– 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
data.

– Prospective subjects: Consent must be obtained within 24 hours of surgery stop
time.

– Retrospective subjects (Control group specific): IRB approval may be granted to
individual sites to waive requirement for informed consent.

Exclusion Criteria:

– 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)

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Completed

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).

For information about this clinical trial here at USC or to see if you qualify, contact us by phone at (800) USC-CARE for more information.

Inclusion Criteria:

– 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.

Exclusion Criteria:

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.

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Recruiting

The INSPIRE Study: Probable Benefit of the Neuro- Spinal Scaffold for Treatment of AIS A Thoracic Acute Spinal Cord Injury

– To evaluate whether the Scaffold is safe and demonstrates probable benefit for the
treatment of complete T2-T12/L1 spinal cord injury .

– This is a Humanitarian Device Exemption (HDE) Probable Benefit Study to demonstrate
safety and probable benefit in support of future studies and an HDE application with
subsequent approval.

For information about this clinical trial here at USC or to see if you qualify, contact us by phone at (800) USC-CARE for more information.

Key Inclusion Criteria:

– Aged 16 – 70 years

– AIS A traumatic spinal cord injury at neurological spinal cord level T2-T12/L1

– Recent injury (must receive Scaffold within 96 hours from injury)

– Non-penetrating contusion injury no less than approximately 4 mm diameter by MRI

Key Exclusion Criteria:

– Incomplete spinal cord injury (AIS B, C, D, E)

– Terminally ill

– Spinal cord injury associated with traumatic brain injury

– Subject on long term mechanical ventilation

– Penetrating injuries

– Radiographic or visual evidence of parenchymal dissociation or anatomic transection
where the contusion completely bridges a full cross-section of the spinal cord

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

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
spinal surgery.

For information about this clinical trial here at USC or to see if you qualify, contact us by phone at (800) USC-CARE for more information.

Inclusion Criteria:

– 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
marrow transplant.

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Recruiting

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).

For information about this clinical trial here at USC or to see if you qualify, contact us by phone at (800) USC-CARE for more information.

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
following injury

– Able to participate in an elective surgical procedure to inject AST-OPC1 21-42 days
following SCI

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

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Recruiting

Study to Assess the Efficacy and Safety of VX-210 in Subjects With Acute Traumatic Cervical Spinal Cord Injury

The purpose of this study is to determine the efficacy and safety of VX-210 in subjects with
Acute Traumatic Cervical Spinal Cord Injury. Secondary objectives include the specific
evaluation of the effects of VX-210 on neurological recovery and daily function after spinal
cord injury.

For information about this clinical trial here at USC or to see if you qualify, contact us by phone at (800) USC-CARE for more information.

Inclusion Criteria:

– Acute traumatic cervical SCI, motor level of C4, C5, C6, or C7 on each side:

– Screening UEMS score must be ≤16 points on each side.

– AIS A subjects with a C4 motor level on both sides must have at least 1 point of
motor activity between C5 and T1 on at least 1 side.

– AIS B subjects with a C4 motor level on both sides must have at least 1 point of
motor activity between C5 and C7 on at least 1 side.

– American Spinal Injury Association Impairment Scale (AIS) grade A or AIS grade B.

– Scheduled and planned to undergo a spinal decompression/stabilization surgery that
commences within 72 hours after the initial injury.

– Computed tomography (CT) scan or magnetic resonance imaging (MRI) is consistent with
the subject’s neurological deficit.

Exclusion Criteria:

– Participation in any other clinical study for acute SCI without approval by the
sponsor.

– Inability to undergo decompression/stabilization surgery that commences within 72
hours after injury.

– One or more upper extremity muscle groups untestable during screening ISNCSCI
examination.

– Acute SCI from gunshot or penetrating/stab wound; non-traumatic SCI (e.g., transverse
myelitis, acute disc herniation); brachial plexus injury; complete spinal cord
transection; or multifocal SCI.

– Females who are breastfeeding or have a positive serum pregnancy test.

– Body mass index (BMI) of ≥40 kg/m2 at screening.

– History of an adverse reaction to a fibrin sealant or its components.

– Unconsciousness or other mental impairment that precludes reliable International
Standards for the Neurological Classification of Spinal Cord Injury (ISNCSCI)
examination.

– Known immunodeficiency, including human immunodeficiency virus, or use of
immunosuppressive or cancer chemotherapeutic drugs.

– Any significant medical or psychiatric comorbidities that would significantly increase
the risk of study enrollment and/or significantly interfere with study outcomes or
assessments, in the judgment of the investigator.

Other protocol defined Inclusion/Exclusion criteria may apply.

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Recruiting