Efficacy of Using Solum IV and BMC With GFC in TLIF

Degenerative Disc Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03223701
• Other study ID #: CR-17-101
• Status: Withdrawn
• Phase: Phase 4
• First received: July 18, 2017
• Last updated: April 16, 2018
• Start date: September 30, 2017
• Est. completion date: December 30, 2018

Study information

• Verified date: April 2018
• Source: Seton Healthcare Family
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 30, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Degenerative Spondylolisthesis
• Intervertebral Disc Degeneration
• Isthmic-lytic Spondylolisthesis
• Spinal Stenosis
• Spondylolisthesis

Intervention

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).

Locations

Country	Name	City	State
United States	Seton Spine and Scoliosis Center	Austin	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Seton Healthcare Family	Celling Biosciences

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View Citation

Hernigou P, Beaujean F. Treatment of osteonecrosis with autologous bone marrow grafting. Clin Orthop Relat Res. 2002 Dec;(405):14-23. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiological assessment : Fusion Status	X-rays (anterior-posterior, lateral, flexion-extension)	3 months post-treatment
Primary	Radiological assessment : Fusion Status	X-rays (anterior-posterior, lateral, flexion-extension)	6 months post-treatment
Primary	Radiological assessment : Fusion Status	X-rays (anterior-posterior, lateral, flexion-extension)	12 months post-treatment
Secondary	Visual Analog Scale	Patient reported pain score	Pre-treatment
Secondary	Visual Analog Scale	Patient reported pain score	3 months post-treatment
Secondary	Visual Analog Scale	Patient reported pain score	6 months post-treatment
Secondary	Visual Analog Scale	Patient reported pain score	12 months post-treatment
Secondary	Oswestry Disability Index	Patient reported disability score	Pre-treatment
Secondary	Oswestry Disability Index	Patient reported disability score	3 months post-treatment
Secondary	Oswestry Disability Index	Patient reported disability score	6 months post-treatment
Secondary	Oswestry Disability Index	Patient reported disability score	12 months post-treatment