Contact us at (800) USC-CARE (800-872-2273)

Clinical Trials

Clinical Trials2021-03-22T12:11:42+00:00

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.

For information about this clinical trial here at USC or to see if you qualify, contact Anush Arakelyan by email at Anush.Arakelyan@med.usc.edu or by phone at (323) 442-7544 for more information.
Inclusion Criteria: The subject must have: 1. Diagnosis of early to moderate degenerative disc disease (DDD), Modified Pfirrmann Grade 3-7. 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 target disc. 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 disc. 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 investigator.
Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Active, not recruiting

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.

For information about this clinical trial here at USC or to see if you qualify, contact Anush Arakelyan by email at Anush.Arakelyan@med.usc.edu or by phone at (323) 442-7544 for more information.
Inclusion Criteria: 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 be eligible) 5. Informed consent obtained 6. 16-70 years of age, inclusive 7. Hemodynamically stable and deemed a suitable candidate for surgery Exclusion Criteria: 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 Investigator) 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) exam 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 HIV infection/AIDS 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 banking 15. Current or impending incarceration 16. Complete spinal cord transection 17. Subjects with spinal cord injuries directly due to gunshot, knife, or other penetrating wounds. 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 implantation 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 efficacy data
Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Active, not recruiting

Evaluation of Safety of HEMOBLAST Bellows in Spine Surgery

The purpose of this clinical investigation in open, elective, spine surgery is to collect data to support the removal of the neurosurgical exclusion from the currently approved indication for the use of HEMOBLAST™ Bellows. This study is primarily designed to assess safety of the device for use in spine surgery, although efficacy information will also be captured and reported.

For information about this clinical trial here at USC or to see if you qualify, contact Anush Arakelyan by email at Anush.Arakelyan@med.usc.edu or by phone at (323) 442-7544 for more information.
Inclusion Criteria: - Subject is undergoing open, elective, spine surgery; - Subject or an authorized legal representative is willing and able to give prior written informed consent for investigation participation; and - Subject is 22 years of age or older - Subject does not have an active or suspected infection at the surgical site; - Subject in whom the Investigator is able to identify a Target Bleeding Site (TBS) for which any applicable conventional means for hemostasis are ineffective or impractical; and - Subject has a TBS with a Surface Bleeding Severity Scale (SBSS) score of 1, 2, or 3. Exclusion Criteria: - Subject is undergoing an emergency surgical procedure; - Subject is undergoing a laparoscopic surgery; - Subject is pregnant, planning on becoming pregnant during the follow-up period, or actively breast-feeding; - Subject has a platelet count < 100,000 per microliter or International Normalized Ratio > 1.5 within 4 weeks of surgery; - Subject receiving intravenous heparin within 12 hours before surgery or oral Coumadin within 2 days before surgery; - Subject receiving antiplatelet medications within 5 days prior to surgery; - Subject receiving aspirin within 7 days prior to surgery; - Subject has an active or suspected infection at the surgical site; - Subject has had or has planned to receive any organ transplantation; - Subject has a known sensitivity or allergy to bovine and/or porcine substance(s) or any other component(s) of the hemostatic agent; - Subject has a known sensitivity or allergy to Gadolinium; - The subject has a contra-indication for MRI or gadolinium contrast agent according to clinical guidelines, local regulations or manufacturer's recommendations; - Subject has American Society of Anesthesiologists classification of > 4; - Subject has a life expectancy of less than 3 months; - Subject has a documented severe congenital or acquired immunodeficiency; - Subject has religious or other objections to porcine, bovine, or human components; - Subject is currently participating or has participated in another clinical trial within the past 30 days and is receiving/has received an investigational drug, device, or biologic agent; and - Per investigator opinion subject is unable to fully cooperate with the study protocol. - The product will be placed in at the site where the dura is open; and - The product will be placed in the intradural or cranial space.
Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Recruiting

A Multicenter Prospective Registry for the Management of Degenerative Spine Disorders

Details regarding the degenerative spine disorders will be collected with a specific focus on the use of osteobiologics in treating degenerative conditions and their impact on fusion, as well as patient-reported outcomes for these conditions.

For information about this clinical trial here at USC or to see if you qualify, contact Anush Arakelyan by email at Anush.Arakelyan@med.usc.edu or by phone at (323) 442-7544 for more information.
Inclusion Criteria: - Patient aged 18 years or older - Patient diagnosed with a degenerative spine disorder who receives treatment for the degenerative spine disorder - Patient capable of understanding the content of the patient information / Informed Consent Form - Patient willing and able to participate in the registry - Patient who has agreed to participate in the registry by providing consent according to the applicable local law and the declaration of Helsinki Exclusion Criteria: - None
Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Recruiting

Umbrella_KeckMedicine
umbrella-logo
Keck Medicine of USC is the University of Southern California’s medical enterprise, one of only two university-owned academic medical centers in the Los Angeles area.