NCT03223701

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).

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 21, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

September 30, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
Last Updated

April 18, 2018

Status Verified

April 1, 2018

Enrollment Period

1 year

First QC Date

July 18, 2017

Last Update Submit

April 16, 2018

Conditions

Degenerative Disc DiseaseIsthmic-lytic SpondylolisthesisDegenerative SpondylolisthesisSpinal Stenosis

Outcome Measures

Primary Outcomes (3)

  • Radiological assessment : Fusion Status

    X-rays (anterior-posterior, lateral, flexion-extension)

    3 months post-treatment

  • Radiological assessment : Fusion Status

    X-rays (anterior-posterior, lateral, flexion-extension)

    6 months post-treatment

  • Radiological assessment : Fusion Status

    X-rays (anterior-posterior, lateral, flexion-extension)

    12 months post-treatment

Secondary Outcomes (8)

  • Visual Analog Scale

    Pre-treatment

  • Visual Analog Scale

    3 months post-treatment

  • Visual Analog Scale

    6 months post-treatment

  • Visual Analog Scale

    12 months post-treatment

  • Oswestry Disability Index

    Pre-treatment

  • +3 more secondary outcomes

Study Arms (1)

Treatment group

OTHER

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

Interventions

Solum IV, Bone Marrow Concentrate with general fluid concentrate (GFC) in Transforaminal Lumbar Interbody FusionCOMBINATION_PRODUCT

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).

Treatment group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject is skeletally mature and older than 18 years of age
  • One and contiguous 2 or 3 level primary lumbar fusions.
  • L1 to S1 with a primary diagnosis of one or more of the following:
  • Degenerative disc disease,
  • Isthmic-lytic spondylolisthesis,
  • Degenerative spondylolisthesis
  • Spinal stenosis.
  • Subject has received conservative (non -surgical treatment for back pain for a minimum of 6 months and is unresponsive
  • Subject understand the conditions of enrollment and is willing to sign and date the informed consent form
  • Subject agrees to comply with study visits

You may not qualify if:

  • Previous bilateral Iliac Crest Bone Graft (ICBG) harvest
  • Previous instrumented fusion at the same or adjacent level
  • Active systemic infection, infection localized to the site of implantation or at aspiration site
  • Vulnerable patients
  • Nursing home residents
  • Prisoners
  • Other institutionalized persons
  • Persons with decisional incapacity
  • Pregnant women or interested in becoming pregnant in the next 12 months
  • Subjects with certain autoimmune diseases (such as lupus)
  • Subject has progressive neuromuscular disease
  • Active hepatitis, AIDS, ARS or is HIV positive
  • Syringomyelia at any spinal levels
  • Any other condition that would interfere with the subject self-assessment of pain, function or quality of life
  • Subjects with multiple allergies
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seton Spine and Scoliosis Center

Austin, Texas, 78731, United States

Location

Related Publications (5)

  • 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.

    PMID: 12461352BACKGROUND

  • 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.

    PMID: 18639333BACKGROUND

  • 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.

    PMID: 20042794BACKGROUND

  • 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.

    PMID: 24503679BACKGROUND

  • 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.

    PMID: 15995108RESULT

MeSH Terms

Conditions

Intervertebral Disc DegenerationSpinal Stenosis

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Eeric Truumees, MD

    Seton Spine and Scoliosis Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2017

First Posted

July 21, 2017

Study Start

September 30, 2017

Primary Completion

September 30, 2018

Study Completion

December 30, 2018

Last Updated

April 18, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)