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Efficacy of Using Solum IV and BMC With GFC in TLIF

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ClinicalTrials.gov Identifier: NCT03223701
Recruitment Status : Withdrawn (Study was never initiated due to contracting issues)
First Posted : July 21, 2017
Last Update Posted : April 18, 2018
Sponsor:
Collaborator:
Celling Biosciences
Information provided by (Responsible Party):
Seton Healthcare Family

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).

Condition or disease Intervention/treatment Phase
Degenerative Disc Disease Isthmic-lytic Spondylolisthesis Degenerative Spondylolisthesis Spinal Stenosis Combination Product: Solum IV, Bone Marrow Concentrate with general fluid concentrate (GFC) in Transforaminal Lumbar Interbody Fusion Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
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).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy Study Using Solum IV, Bone Marrow Concentrate With General Fluid Concentrate in Transforaminal Lumbar Interbody Fusion
Estimated Study Start Date : September 30, 2017
Estimated Primary Completion Date : September 30, 2018
Estimated Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Treatment group
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).



Primary Outcome Measures :
  1. Radiological assessment : Fusion Status [ Time Frame: 3 months post-treatment ]
    X-rays (anterior-posterior, lateral, flexion-extension)

  2. Radiological assessment : Fusion Status [ Time Frame: 6 months post-treatment ]
    X-rays (anterior-posterior, lateral, flexion-extension)

  3. Radiological assessment : Fusion Status [ Time Frame: 12 months post-treatment ]
    X-rays (anterior-posterior, lateral, flexion-extension)


Secondary Outcome Measures :
  1. Visual Analog Scale [ Time Frame: Pre-treatment ]
    Patient reported pain score

  2. Visual Analog Scale [ Time Frame: 3 months post-treatment ]
    Patient reported pain score

  3. Visual Analog Scale [ Time Frame: 6 months post-treatment ]
    Patient reported pain score

  4. Visual Analog Scale [ Time Frame: 12 months post-treatment ]
    Patient reported pain score

  5. Oswestry Disability Index [ Time Frame: Pre-treatment ]
    Patient reported disability score

  6. Oswestry Disability Index [ Time Frame: 3 months post-treatment ]
    Patient reported disability score

  7. Oswestry Disability Index [ Time Frame: 6 months post-treatment ]
    Patient reported disability score

  8. Oswestry Disability Index [ Time Frame: 12 months post-treatment ]
    Patient reported disability score



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03223701


Locations
United States, Texas
Seton Spine and Scoliosis Center
Austin, Texas, United States, 78731
Sponsors and Collaborators
Seton Healthcare Family
Celling Biosciences
Investigators
Principal Investigator: Eeric Truumees, MD Seton Spine and Scoliosis Center

Publications of Results:
Other Publications:
Responsible Party: Seton Healthcare Family
ClinicalTrials.gov Identifier: NCT03223701     History of Changes
Other Study ID Numbers: CR-17-101
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
Spinal Stenosis
Intervertebral Disc Degeneration
Spondylolisthesis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Spondylolysis
Spondylosis