Degenerative Disc DiseasePhase 4NCT03223701
Efficacy of Using Solum IV and BMC With GFC in TLIF
A Phase 4 study testing Solum IV, Bone Marrow Concentrate with general fluid concentrate (GFC) in Transforaminal Lumbar Interbody Fusion in people with Degenerative Disc Disease and Isthmic-lytic Spondylolisthesis, run by Seton Healthcare Family at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Degenerative Disc Disease, Isthmic-lytic Spondylolisthesis, Degenerative Spondylolisthesis
- What is being tested?
- Solum IV, Bone Marrow Concentrate with general fluid concentrate (GFC) in Transforaminal Lumbar Interbody Fusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2017to 30 Dec 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
- -
Who cannot join
- 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
Show all 28Show fewer
- 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
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Seton Spine and Scoliosis Center
Austin, Texas, 78731
About this study
Official title: Efficacy Study Using Solum IV, Bone Marrow Concentrate With General Fluid Concentrate in Transforaminal Lumbar Interbody Fusion
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).
Read the 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
- Being tested
- Solum IV, Bone Marrow Concentrate with general fluid concentrate (GFC) in Transforaminal Lumbar Interbody Fusion
- Medical subject headings
- Intervertebral Disc Degeneration, Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Combination Product: Solum IV, Bone Marrow Concentrate with general fluid concentrate (GFC) in Transforaminal Lumbar Interbody Fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological assessment : Fusion Status
X-rays (anterior-posterior, lateral, flexion-extension)
Measured: 3 months post-treatment
Radiological assessment : Fusion Status
X-rays (anterior-posterior, lateral, flexion-extension)
Measured: 6 months post-treatment
Radiological assessment : Fusion Status
X-rays (anterior-posterior, lateral, flexion-extension)
Measured: 12 months post-treatment
Secondary outcomes (8)
Visual Analog Scale
Patient reported pain score
Measured: Pre-treatment
Visual Analog Scale
Patient reported pain score
Measured: 3 months post-treatment
Visual Analog Scale
Patient reported pain score
Measured: 6 months post-treatment
Visual Analog Scale
Patient reported pain score
Measured: 12 months post-treatment
Oswestry Disability Index
Patient reported disability score
Measured: Pre-treatment
Oswestry Disability Index
Patient reported disability score
Measured: 3 months post-treatment
Oswestry Disability Index
Patient reported disability score
Measured: 6 months post-treatment
Oswestry Disability Index
Patient reported disability score
Measured: 12 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start30 Sep 2017 (estimated)
- Primary completion30 Sep 2018 (estimated)
- Study completion30 Dec 2018 (estimated)
Why it stopped: Study was never initiated due to contracting issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Degenerative Disc DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seton Healthcare Family
- Sponsor type
- University, hospital or other
- Collaborators
- Celling Biosciences
- Responsible party
- Sponsor
- Investigators
- Eeric Truumees, MD, Principal investigator, Seton Spine and Scoliosis Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03223701
- Sponsor's protocol ID
- CR-17-101
- Status last verified
- Apr 2018
- First submitted
- 18 Jul 2017
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 12461352Gan 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.
PubMed 18639333Galois 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.
PubMed 20042794Johnson 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.
PubMed 24503679Hernigou 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.
PubMed 15995108
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Study Using Solum IV, Bone Marrow Concentrate With General Fluid Concentrate in Transforaminal Lumbar Interbody Fusion
- ClinicalTrials.gov ID
- NCT03223701
- Acronym / sponsor ID
- CR-17-101
- Conditions
- Degenerative Disc Disease, Isthmic-lytic Spondylolisthesis, Degenerative Spondylolisthesis, Spinal Stenosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was never initiated due to contracting issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Seton Healthcare FamilyUniversity, hospital or other
- Collaborators
- Celling Biosciences
- Study start
- 30 Sep 2017 (estimated)
- Primary completion
- 30 Sep 2018 (estimated)
- Study completion
- 30 Dec 2018 (estimated)
- First posted
- 21 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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).
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Other | Combination Product: Solum IV, Bone Marrow Concentrate with general fluid concentrate (GFC) in Transforaminal Lumbar Interbody FusionThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
- 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
Key exclusion criteria (28 listed)
- 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
- Pregnant women or interested in becoming pregnant in the next 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Solum IV, Bone Marrow Concentrate with general fluid concentrate (GFC) in Transforaminal Lumbar Interbody FusionThe 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). | Combination product | Treatment group |
Primary outcome
Radiological assessment : Fusion Status
Time frame: 3 months post-treatment
X-rays (anterior-posterior, lateral, flexion-extension)
Radiological assessment : Fusion Status
Time frame: 6 months post-treatment
X-rays (anterior-posterior, lateral, flexion-extension)
Radiological assessment : Fusion Status
Time frame: 12 months post-treatment
X-rays (anterior-posterior, lateral, flexion-extension)
8 secondary outcomes
Visual Analog Scale
Time frame: Pre-treatment
Visual Analog Scale
Time frame: 3 months post-treatment
Visual Analog Scale
Time frame: 6 months post-treatment
Visual Analog Scale
Time frame: 12 months post-treatment
Oswestry Disability Index
Time frame: Pre-treatment
Oswestry Disability Index
Time frame: 3 months post-treatment
Oswestry Disability Index
Time frame: 6 months post-treatment
Oswestry Disability Index
Time frame: 12 months post-treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
- Background: PubMed 12461352Hernigou 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.
- Background: PubMed 18639333Gan 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.
- Background: PubMed 20042794Galois 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.
- Background: PubMed 24503679Johnson 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 publication: PubMed 15995108Hernigou 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eeric Truumees, MD principal investigator
Seton Spine and Scoliosis Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Solum IV, Bone Marrow Concentrate with general fluid concentrate (GFC) in Transforaminal Lumbar Interbody Fusion in people with Degenerative Disc Disease and Isthmic-lytic Spondylolisthesis, run by Seton Healthcare Family at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiological assessment : Fusion Status (time frame: 3 months post-treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03223701, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2018.