Clinical trial NCT03223701: Efficacy of Using Solum IV and BMC With GFC in TLIF
Official title: Efficacy Study Using Solum IV, Bone Marrow Concentrate With General Fluid Concentrate in Transforaminal Lumbar Interbody Fusion
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Degenerative Disc Disease
Isthmic-lytic Spondylolisthesis
Degenerative Spondylolisthesis
Spinal Stenosis
Lead sponsor: Seton Healthcare Family
Sponsor class: OTHER
Collaborators: name: Celling Biosciences
First posted: 2017-07-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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).
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Subject is skeletally mature and older than 18 years of age
2. One and contiguous 2 or 3 level primary lumbar fusions.
3. L1 to S1 with a primary diagnosis of one or more of the following:

   1. Degenerative disc disease,
   2. Isthmic-lytic spondylolisthesis,
   3. Degenerative spondylolisthesis
   4. Spinal stenosis.
4. Subject has received conservative (non -surgical treatment for back pain for a minimum of 6 months and is unresponsive
5. Subject understand the conditions of enrollment and is willing to sign and date the informed consent form
6. Subject agrees to comply with study visits

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Exclusion Criteria:

1. Previous bilateral Iliac Crest Bone Graft (ICBG) harvest
2. Previous instrumented fusion at the same or adjacent level
3. Active systemic infection, infection localized to the site of implantation or at aspiration site
4. Vulnerable patients

   1. Nursing home residents
   2. Prisoners
   3. Other institutionalized persons
   4. Persons with decisional incapacity
5. Pregnant women or interested in becoming pregnant in the next 12 months
6. Subjects with certain autoimmune diseases (such as lupus)
7. Subject has progressive neuromuscular disease
8. Active hepatitis, AIDS, ARS or is HIV positive
9. Syringomyelia at any spinal levels
10. Any other condition that would interfere with the subject self-assessment of pain, function or quality of life
11. Subjects with multiple allergies
12. Subjects with any history of cancer (except for basal cell carcinoma of the skin)
13. Significant osteoporosis
14. Subject is younger than or equal to 18 years of age
15. Subjects with a BMI of 40 or greater
16. Subject has diabetes mellitus requiring daily insulin management
17. Subject has allergy to implant materials (such as titanium, titanium alloy)
18. Subject has primary or metastatic tumors involving the spine
19. Subject is participating in another investigational study for a similar purpose
20. Subject has a history of significant mental illness or mental incapacity
21. 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
22. Subject is receiving workers compensation
23. Absence of English language reading or writing skills

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Primary outcomes:
measure: Radiological assessment : Fusion Status
timeFrame: 3 months post-treatment
measure: Radiological assessment : Fusion Status
timeFrame: 6 months post-treatment
measure: Radiological assessment : Fusion Status
timeFrame: 12 months post-treatment
Secondary outcomes:
measure: Visual Analog Scale
timeFrame: Pre-treatment
measure: Visual Analog Scale
timeFrame: 3 months post-treatment
measure: Visual Analog Scale
timeFrame: 6 months post-treatment
measure: Visual Analog Scale
timeFrame: 12 months post-treatment
measure: Oswestry Disability Index
timeFrame: Pre-treatment
measure: Oswestry Disability Index
timeFrame: 3 months post-treatment
measure: Oswestry Disability Index
timeFrame: 6 months post-treatment
measure: Oswestry Disability Index
timeFrame: 12 months post-treatment
Other outcomes:
Locations:
city: Austin
country: United States
facility: Seton Spine and Scoliosis Center
state: Texas
Study officials:
affiliation: Seton Spine and Scoliosis Center
name: Eeric Truumees, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hernigou P, Beaujean F. Treatment of osteonecrosis with autologous bone marrow grafting. Clin Orthop Relat Res. 2002 Dec;(405):14-23. doi: 10.1097/00003086-200212000-00003.
citation: Gan Y, Dai K, Zhang P, Tang T, Zhu Z, Lu J. The clinical use of enriched bone marrow stem cells combined with porous beta-tricalcium phosphate in posterior spinal fusion. Biomaterials. 2008 Oct;29(29):3973-82. doi: 10.1016/j.biomaterials.2008.06.026. Epub 2008 Jul 18.
citation: Galois L, Bensoussan D, Diligent J, Pinzano A, Henrionnet C, Choufani E, Stoltz JF, Mainard D. Autologous bone marrow graft and treatment of delayed and non-unions of long bones: technical aspects. Biomed Mater Eng. 2009;19(4-5):277-81. doi: 10.3233/BME-2009-0592.
citation: Johnson RG. Bone marrow concentrate with allograft equivalent to autograft in lumbar fusions. Spine (Phila Pa 1976). 2014 Apr 20;39(9):695-700. doi: 10.1097/BRS.0000000000000254.
citation: Hernigou P, Poignard A, Beaujean F, Rouard H. Percutaneous autologous bone-marrow grafting for nonunions. Influence of the number and concentration of progenitor cells. J Bone Joint Surg Am. 2005 Jul;87(7):1430-7. doi: 10.2106/JBJS.D.02215.