Efficacy of Using Solum IV and BMC With GFC in TLIF

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Efficacy Study Using Solum IV, Bone Marrow Concentrate With General Fluid Concentrate in Transforaminal Lumbar Interbody Fusion

Conditions
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Spinal Stenosis, Degenerative Disc Disease, Isthmic-lytic Spondylolisthesis, Degenerative Spondylolisthesis

Intervention / Treatment
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* Combination Product: Solum IV, Bone Marrow Concentrate with general fluid concentrate (GFC) in Transforaminal Lumbar Interbody Fusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is skeletally mature and older than 18 years of age One and contiguous 2 or 3 level primary lumbar fusions. L1 to S1 with a primary diagnosis of one or more of the following: Degenerative disc disease, Isthmic-lytic spondylolisthesis, Degenerative spondylolisthesis Spinal stenosis. Subject has received conservative (non -surgical treatment for back pain for a minimum of 6 months and is unresponsive Subject understand the conditions of enrollment and is willing to sign and date the informed consent form Subject agrees to comply with study visits - Exclusion Criteria: Previous bilateral Iliac Crest Bone Graft (ICBG) harvest Previous instrumented fusion at the same or adjacent level Active systemic infection, infection localized to the site of implantation or at aspiration site Vulnerable patients Nursing home residents Prisoners Other institutionalized persons Persons with decisional incapacity Pregnant women or interested in becoming pregnant in the next 12 months Subjects with certain autoimmune diseases (such as lupus) Subject has progressive neuromuscular disease Active hepatitis, AIDS, ARS or is HIV positive Syringomyelia at any spinal levels Any other condition that would interfere with the subject self-assessment of pain, function or quality of life Subjects with multiple allergies Subjects with any history of cancer (except for basal cell carcinoma of the skin) Significant osteoporosis Subject is younger than or equal to 18 years of age Subjects with a BMI of 40 or greater Subject has diabetes mellitus requiring daily insulin management Subject has allergy to implant materials (such as titanium, titanium alloy) Subject has primary or metastatic tumors involving the spine Subject is participating in another investigational study for a similar purpose Subject has a history of significant mental illness or mental incapacity Subject is currently smoker and will not cease smoking from the time of study enrollment up through 3 months post-operatively, nicotine users for whom post-operative bone stimulation would be prescribed, or has a recent history of alcohol or other substance abuse within the past 2 years Subject is receiving workers compensation Absence of English language reading or writing skills -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This is a prospective, single-center clinical study. Ten patients will be enrolled and undergo an Transforaminal Lumbar Interbody Fusion (TLIF) with a spinal fixation system and receive Solum IV (Celling Biosciences) and patient's bone marrow concentrate with general fluid concentrate (GFC).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Treatment group<br>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<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiological assessment : Fusion Status | X-rays (anterior-posterior, lateral, flexion-extension) | 3 months post-treatment | 
| Radiological assessment : Fusion Status | X-rays (anterior-posterior, lateral, flexion-extension) | 6 months post-treatment | 
| Radiological assessment : Fusion Status | X-rays (anterior-posterior, lateral, flexion-extension) | 12 months post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale | Patient reported pain score | Pre-treatment | 
| Visual Analog Scale | Patient reported pain score | 3 months post-treatment | 
| Visual Analog Scale | Patient reported pain score | 6 months post-treatment | 
| Visual Analog Scale | Patient reported pain score | 12 months post-treatment | 
| Oswestry Disability Index | Patient reported disability score | Pre-treatment | 
| Oswestry Disability Index | Patient reported disability score | 3 months post-treatment | 
| Oswestry Disability Index | Patient reported disability score | 6 months post-treatment | 
| Oswestry Disability Index | Patient reported disability score | 12 months post-treatment |