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Study Title Principal Investigator
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of SUN13837 Injection in Adult Subjects With Acute Spinal Cord Injury
Active, not recruiting | Spinal Cord Injury | Multisite
Patrick Hsieh
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A Single-Blind, Randomized, Parallel Arm, Phase II Proof-of-Concept Study of the Safety and Efficacy of Human Central Nervous System Stem Cells (HuCNS-SC) Transplantation in Cervical Spinal Cord Injury
Terminated | Spinal Cord Injury | Multisite
Stephen Huhn
The INSPIRE Study: InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold(TM) for Safety and Neurologic Recovery in Subjects With Complete Thoracic AIS A 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)-co-poly-(L-lysine)) Scaffold ("Scaffold") in subjects with complete T2-T12/L1 thoracic AIS A traumatic spinal cord injury. Subjects who have experienced a recent (must receive Scaffold within 96 hours from injury) spinal cord injury (AIS A) from T2 to T12/L1 (neurological spinal cord level) will be screened for participation. After informed consent is obtained, neurological status will be assessed according to the International Standards for Neurological Classifications of SCI (ISNCSCI) as developed by ASIA. The 5-grade ASIA Impairment Scale will be used to determine the completeness of a subject's injury. The ISNCSCI examination includes sensory and motor function assessments. A rectal examination will be used to assess deep anal pressure sensation and voluntary anal contraction to determine the completeness of the injury. Any variables that may affect the ability to obtain a reliable ISNCSCI exam should be eliminated (e.g., temporarily eliminating medication that would interfere with a valid ISNCSCI exam for ventilated subjects). Furthermore, magnetic resonance imaging (MRI) studies without contrast will be performed to measure and characterize the contusion and its location. The contusion dimensions (length and anteroposterior diameter) will be estimated. The MRI will also be used to assess the presence or absence of a cavity, parenchymal sparing, atrophic changes of the cord, and areas of edema and hemorrhage. Other baseline assessments at screening will include subject demographics, general medical/medication history, physical examination, neurological exam, resting vital signs, Vital Capacity (VC) for subjects who are not ventilator dependent, and baseline clinical laboratory tests. Body mass index (BMI) at screening will be calculated based on actual, self-reported or family-reported weight and height. For subjects ages 16 and 17, baseline skeletal maturity will be assessed using an accepted measure (e.g. bone age as determined by hand and wrist x-ray or Risser stage as determined by iliac crest x-ray) prior to hospital discharge, but assessment is not required prior to open spine surgery/Scaffold implant. X-rays obtained during the preoperative period may be used for this assessment. If clinical assessments are conducted during post-injury care and before informed consent is obtained, they may be used for the study once informed consent is obtained. Within approximately 8 hours prior to open spine surgery, the AIS classification of the subject will be confirmed to ensure only subjects with a reliable AIS A classification will be implanted with the Scaffold. The Scaffold will be implanted at the time of open spine surgery and not during a second or separate surgery, and ideally within 24 hours from the time of injury but no longer than 96 hours from the time of injury. After completion of the spine surgery, the Investigator will ensure the subject continues to meet eligibility criteria. For subjects with a T2 or T3 neurological level of injury, bilateral intraoperative median and ulnar nerve somatosensory evoked potential (SSEP) monitoring will be performed as an added safety precaution for the investigational procedure from durotomy through Scaffold placement and dural closure. The objective of this monitoring is to identify potential loss of neurologic function of the hand at the C8 and T1 neurologic levels. The median nerve signals can be used as a control for the C8 and T1 levels as the median nerve also includes contribution from C7. An adequate baseline should be obtained per institutional protocol to ensure interpretable recordings from both median and ulnar SSEPs prior to beginning the investigational procedure (i.e. prior to the durotomy). Should the SSEP recordings indicate potential loss of function, appropriate steps should be taken per institutional guidelines such as adjustment of anesthesia, operating procedure, etc. The Investigator should determine whether the Scaffold can be placed safely if this deterioration occurs prior to Scaffold placement. The Investigator may also utilize additional modes of intraoperative neuromonitoring such as motor evoked potentials (MEPs), if the risk of upper extremity movement is outweighed by the potential benefit. If the surgical procedure includes anterior cord manipulation, stronger consideration should be given to use of MEPs of the abductor pollicis brevis (C8, T1). Changes in ventilator parameters due to worsening of pulmonary function will be documented during the investigational portion of the open spine surgery (durotomy, myelotomy, Scaffold implant, dural closure). If changes in ventilator parameters are necessitated by a worsening of pulmonary function, the Investigator will document the ventilator setting changes and assess if the worsening is due to the Scaffold implant procedure. Upon visualization of the dura, an intraoperative ultrasound will be performed to evaluate and confirm the contusion size, presence or absence of a cavity, and location of the contusion, as initially assessed by the preoperative MRI. Based upon the contusion cavity size, the Investigator will select and prepare an appropriately sized Scaffold. The Investigator will then perform a durotomy, arachnoid/pial resection, and after the epicenter of the contusion cavity has been identified/reached (e.g., by myelotomy), further irrigate the contusion with isotonic saline for the purposes of debridement as necessary to remove additional areas of hemorrhage and necrotic tissue within the cavity. During gentle irrigation, Investigator will capture a sample of the spontaneous exudate if present and submit to pathology for routine examination/testing, for example Hematoxylin and Eosin (H&E) staining for histology. Next, the Scaffold will be placed into the epicenter of the intra-spinal post-irrigation contusion cavity. A second intraoperative ultrasound, with photograph, should be performed to confirm placement of the Scaffold in the spinal cord. The dura will be closed in standard surgical fashion. If there is significant spinal cord edema or swelling such that a standard primary dural closure would compress spinal cord tissue, a duraplasty can be considered. The surgical wound will then be closed and dressed according to standard clinical practice. Following surgery, vital signs will be monitored and qualified medical personnel will perform neurological examinations in a manner consistent with standard post-anesthesia care. Subjects will be cared for in the hospital and after discharge following the standard medical care practice for SCI patients. The cylindrical-shaped Scaffold is a bioresorbable material, and based upon pre-clinical testing, is expected to be cleared from the site of implant within four to eight weeks. Therefore, the post-Scaffold implantation Follow-up study visits will be determined based on the date/time the Scaffold implantation procedure was finished and will be at 24 hours, 48 hours, 72 hours, 1 week, at hospital discharge, 1 month, 2 months, 3 months, and 6 months. The Long-Term follow-up visits will be in clinic at 12 months and 24 months, and annually by phone for years 3 through 10. Post-Scaffold implantation Follow-up assessments will consist of ISNCSCI, neurological examinations (including hip abduction/adduction and great toe flexion/extension at Discharge through 6 Month Primary Endpoint Follow-up Visit), Spinal Cord Independence Measure (SCIM III), Ferrans and Powers Quality of Life Index - Spinal Cord Injury (QLI-SCI III), Beck Depression Inventory-II (BDI-II), bowel and bladder function, routine laboratory tests, Vital Capacity (VC) for subjects who are not ventilator dependent, and resting vital signs. In addition, an MRI without contrast will be performed at the 72 Hour, 3 Month and 6 Month Primary Endpoint Follow-up Visits, and a physical exam will be performed at the Discharge Visit and the 6 Month Primary Endpoint Follow-up Visit. Safety event monitoring including procedure and Scaffold related complications will occur at all Follow-up Visits and will include adverse device effects (ADEs), unanticipated adverse device effects (UADEs), and all serious safety events (SAEs/SADEs). Subjects will participate in comprehensive rehabilitative programs for spinal cord surgery patients and a Rehabilitation Therapy Log will be completed. Long-Term Follow-up assessments will be conducted in clinic at 12 months and 24 months post-Scaffold implantation, and annually for years 3 - 10. In-clinic Long-Term Follow-up Visits will consist of ISNCSCI, neurological examinations including hip abduction/adduction and great toe flexion/extension, MRI without contrast, routine laboratory tests, resting vital signs and a physical exam. At the 12 Month Long-Term Follow-up Visit only, SCIM III, QLI-SCI III, BDI-II, and bowel and bladder function will be assessed. The Rehabilitation Therapy Log will be completed through the 12 month Long-Term Follow-up Visit. Safety event monitoring including procedure and Scaffold related complications will occur at the 12 Month and 24 Month Long-Term Follow-up visits and will include adverse device effects (ADEs), unanticipated adverse device effects (UADEs), and all serious safety events (SAEs/SADEs). An annual telephone Long-Term Follow-up Visit will be conducted for years 3 - 10 and will collect general health information. If at any time during the Follow-up or Long-Term Follow-up periods, the subject reports a neurologic deterioration consisting of loss of bowel or bladder function or complete loss of motor function at any joint that had at least 2+ movement at the prior examination, the subject will be asked to return to the clinic for a follow-up evaluation.
Active, not recruiting | Spinal Cord Injury | Multisite
Richard Toselli
A Phase 1/2a Dose Escalation Study of AST-OPC1 in Subjects With Subacute Cervical Spinal Cord Injury
Completed | Spinal Cord Injury | Multisite
Edward III
A Phase III, Multicentre, Randomised, Double Blind, Parallel Group, Placebo Controlled Study To Assess The Efficacy And Safety Of One Or More Intradetrusor Treatments Of 600 Or 800 Units of Dysport® For The Treatment Of Urinary Incontinence In Subjects With Neurogenic Detrusor Overactivity Due To Spinal Cord Injury Or Multiple Sclerosis
Active, not recruiting | Multiple Sclerosis | Multisite
Ipsen Director
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