NCT03223701

Efficacy of Using Solum IV and BMC With GFC in TLIF

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

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Seton Healthcare Family · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2017-09-30
• Primary completion: 2018-09-30
• Completion: 2018-12-30
• First posted: 2017-07-21
• Last updated: 2018-04-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study