Efficacy of Using Solum IV and BMC With GFC in TLIF

PHASE4WithdrawnINTERVENTIONAL
0
Timeline

Start Date

September 30, 2017

Primary Completion Date

September 30, 2018

Study Completion Date

December 30, 2018

Conditions
Degenerative Disc DiseaseIsthmic-lytic SpondylolisthesisDegenerative SpondylolisthesisSpinal Stenosis
Interventions
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).

Trial Locations (1)

78731

Seton Spine and Scoliosis Center, Austin

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Celling Biosciences

UNKNOWN

lead

Seton Healthcare Family

OTHER