Back to results

Efficacy of Using Solum IV and BMC With GFC in TLIF

Primary Purpose

Degenerative Disc Disease, Isthmic-lytic Spondylolisthesis, Degenerative Spondylolisthesis

Status

Withdrawn

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Degenerative Disc Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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:
1. Degenerative disc disease,
2. Isthmic-lytic spondylolisthesis,
3. Degenerative spondylolisthesis
4. 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
-

Exclusion Criteria:

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
1. Nursing home residents
2. Prisoners
3. Other institutionalized persons
4. 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
Subjects with any history of cancer (except for basal cell carcinoma of the skin)
Significant osteoporosis
Subject is younger than or equal to 18 years of age
Subjects with a BMI of 40 or greater
Subject has diabetes mellitus requiring daily insulin management
Subject has allergy to implant materials (such as titanium, titanium alloy)
Subject has primary or metastatic tumors involving the spine
Subject is participating in another investigational study for a similar purpose
Subject has a history of significant mental illness or mental incapacity
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
Subject is receiving workers compensation
Absence of English language reading or writing skills
-

Sites / Locations

Seton Spine and Scoliosis Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Treatment group

Arm Description

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.

Outcomes

Primary Outcome Measures

Radiological assessment : Fusion Status

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

Radiological assessment : Fusion Status

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

Radiological assessment : Fusion Status

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

Secondary Outcome Measures

Visual Analog Scale

Patient reported pain score

Visual Analog Scale

Patient reported pain score

Visual Analog Scale

Patient reported pain score

Visual Analog Scale

Patient reported pain score

Oswestry Disability Index

Patient reported disability score

Oswestry Disability Index

Patient reported disability score

Oswestry Disability Index

Patient reported disability score

Oswestry Disability Index

Patient reported disability score

Full Information

NCT ID

NCT03223701

First Posted

July 18, 2017

Last Updated

April 16, 2018

Sponsor

Seton Healthcare Family

Collaborators

Celling Biosciences

1. Study Identification

Unique Protocol Identification Number

NCT03223701

Brief Title

Efficacy of Using Solum IV and BMC With GFC in TLIF

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Withdrawn

Why Stopped

Study was never initiated due to contracting issues

Study Start Date

September 30, 2017 (Anticipated)

Primary Completion Date

September 30, 2018 (Anticipated)

Study Completion Date

December 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Seton Healthcare Family

Collaborators

Celling Biosciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

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)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment group

Arm Type

Other

Arm Description

Intervention Type

Combination Product

Intervention Name(s)

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

Intervention Description

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 Measure Information:

Title

Radiological assessment : Fusion Status

Description

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

Time Frame

3 months post-treatment

Title

Radiological assessment : Fusion Status

Description

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

Time Frame

6 months post-treatment

Title

Radiological assessment : Fusion Status

Description

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

Time Frame

12 months post-treatment

Secondary Outcome Measure Information:

Title

Visual Analog Scale

Description

Patient reported pain score

Time Frame

Pre-treatment

Title

Visual Analog Scale

Description

Patient reported pain score

Time Frame

3 months post-treatment

Title

Visual Analog Scale

Description

Patient reported pain score

Time Frame

6 months post-treatment

Title

Visual Analog Scale

Description

Patient reported pain score

Time Frame

12 months post-treatment

Title

Oswestry Disability Index

Description

Patient reported disability score

Time Frame

Pre-treatment

Title

Oswestry Disability Index

Description

Patient reported disability score

Time Frame

3 months post-treatment

Title

Oswestry Disability Index

Description

Patient reported disability score

Time Frame

6 months post-treatment

Title

Oswestry Disability Index

Description

Patient reported disability score

Time Frame

12 months post-treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 - Exclusion Criteria: 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 Subjects with any history of cancer (except for basal cell carcinoma of the skin) Significant osteoporosis Subject is younger than or equal to 18 years of age Subjects with a BMI of 40 or greater Subject has diabetes mellitus requiring daily insulin management Subject has allergy to implant materials (such as titanium, titanium alloy) Subject has primary or metastatic tumors involving the spine Subject is participating in another investigational study for a similar purpose Subject has a history of significant mental illness or mental incapacity 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 Subject is receiving workers compensation Absence of English language reading or writing skills -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eeric Truumees, MD

Organizational Affiliation

Seton Spine and Scoliosis Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seton Spine and Scoliosis Center

City

Austin

State/Province

Texas

ZIP/Postal Code

78731

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

12461352

Citation

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.

Results Reference

background

PubMed Identifier

18639333

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.

Results Reference

background

PubMed Identifier

20042794

Citation

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.

Results Reference

background

PubMed Identifier

24503679

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.

Results Reference

background

PubMed Identifier

15995108

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. doi: 10.2106/JBJS.D.02215.

Results Reference

result

Learn more about this trial

Efficacy of Using Solum IV and BMC With GFC in TLIF

We'll reach out to this number within 24 hrs