A Phase 4 interventional study of Solum IV, Bone Marrow Concentrate with general fluid concentrate (GFC) in Transforaminal Lumbar Interbody Fusion in Degenerative Disc Disease, Isthmic-lytic Spondylolisthesis and Degenerative Spondylolisthesis, sponsored by Seton Healthcare Family. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-18.
Sponsored by Seton Healthcare Family · Phase 4, Interventional, and Treatment
The purpose of this study is to examine the efficacy of using Solum IV and bone marrow concentrate with general fluid concentrate in Transforaminal Lumbar Interbody Fusion (TLIF).
This is a prospective, single-center clinical study. Ten patients will be enrolled and undergo an TLIF with a spinal fixation system and receive Solum IV (Celling Biosciences) and patient's BMC with GFC.
The bone marrow aspirate (BMA) will be taken from the iliac crest of the enrolled subjects. The BMA will be transferred to a processor that will use ART BMC Plus (Celling Biosciences, Austin, TX) platform technology to obtain the BMC preparation. The plasma component that remains as a by-product of generating the BMC will then be concentrated by the ART BMC Plus device to create a concentrated plasma/general fluid concentrate (GFC). The enrolled subjects' BMC and GFC will be provided to the principle investigator who will combine the two together with Solum IV using the Graft Delivery Kit (Celling Biosciences) and perform a TLIF procedure. (See Appendix B for Graft Delivery Kit). All subjects will be assigned to receive lumbar interbody fusion via a TLIF approach with Solum IV bone graft and BMC with GFC in the interbody space of a TLIF using cynch bullet cage (@SpineSmith) and Stryker based pedicle screw system (Xia 3 system).
All study subjects will be assessed for fusion rate, complication rates and subject-reported outcomes at designated intervals up to 12 months after surgery. X-rays (anterior-posterior, lateral, flexion-extension) will be taken at pre-operatively, 3, 6, and 12 months post-treatment.
459 studies on the registry are indexed under Spinal Stenosis; 103 are open to participants now.
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L1 to S1 with a primary diagnosis of one or more of the following:
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Exclusion Criteria:
Vulnerable patients
Absence of English language reading or writing skills
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The group will consist of 10 patients who would be examined for fusion rates of Transforaminal Lumbar Interbody Fusion with a standalone lumbar implant device and Solum IV and the patient's bone marrow concentrate and general fluid concentrate.
Combination Product: Solum IV, Bone Marrow Concentrate with general fluid concentrate (GFC) in Transforaminal Lumbar Interbody Fusion
The bone marrow aspirate (BMA) will be taken from the iliac crest of the enrolled subjects. The BMA will be transferred to a processor that will use ART BMC Plus (Celling Biosciences, Austin, TX) platform technology to obtain the BMC preparation. The plasma component that remains as a by-product of generating the BMC will then be concentrated by the ART BMC Plus device to create a concentrated plasma/general fluid concentrate (GFC). The enrolled subjects' BMC and GFC will be provided to the principle investigator who will combine the two together with Solum IV using the Graft Delivery Kit (Celling Biosciences) and perform a TLIF procedure. (See Appendix B for Graft Delivery Kit). All subjects will be assigned to receive lumbar interbody fusion via a TLIF approach with Solum IV bone graft and BMC with GFC in the interbody space of a TLIF using cynch bullet cage (@SpineSmith) and Stryker based pedicle screw system (Xia 3 system).
Radiological assessment : Fusion Status
X-rays (anterior-posterior, lateral, flexion-extension)
Time frame: 3 months post-treatment
Radiological assessment : Fusion Status
X-rays (anterior-posterior, lateral, flexion-extension)
Time frame: 6 months post-treatment
Radiological assessment : Fusion Status
X-rays (anterior-posterior, lateral, flexion-extension)
Time frame: 12 months post-treatment
Visual Analog Scale
Patient reported pain score
Time frame: Pre-treatment
Visual Analog Scale
Patient reported pain score
Time frame: 3 months post-treatment
Visual Analog Scale
Patient reported pain score
Time frame: 6 months post-treatment
Visual Analog Scale
Patient reported pain score
Time frame: 12 months post-treatment
Oswestry Disability Index
Patient reported disability score
Time frame: Pre-treatment
Oswestry Disability Index
Patient reported disability score
Time frame: 3 months post-treatment
Oswestry Disability Index
Patient reported disability score
Time frame: 6 months post-treatment
Oswestry Disability Index
Patient reported disability score
Time frame: 12 months post-treatment
Plan to share: No
This study is withdrawn, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Seton Healthcare Family