An interventional study of Autologous Bone Marrow Aspirate Concentrate (BMAC) Injection in Degenerative Disc Disease and Spine Degeneration, sponsored by Bone and Joint Clinic of Baton Rouge. Status unknown at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-03-16.
Sponsored by Bone and Joint Clinic of Baton Rouge · Not applicable, Interventional, and Treatment
This single-institution prospective case series (single arm) study will assess the clinical outcomes of patients diagnosed with 1 or 2 level level discogenic low back pain following an intradiscal injection of bone marrow aspirate concentrate (BMAC).
Background:
BMAC is a cellular rich fraction of bone marrow aspirate that can be readily prepared at the point of care without additional processing steps to manipulate or isolate cells. In addition, BMAC contains growth factors from the peripheral blood which may promote disc healing.
Study Summary:
The study population will consist of up to 20 patients aged 18- 60 with unresolved low back pain attributable to intervertebral disc degeneration. Clinical exam will indicate the intervertebral disc as the source of pain with features such as midline pain, pain upon rising from a seated position, or positive responses to centralization maneuvers. Moderate single level lumbar disc (L1-S1) degeneration (\<50% disc height) will be confirmed on MRI. Other low back pain generators must be eliminated prior to study enrollment. Subjects must meet minimum score criteria on baseline PROs (VAS>=40 and ODI>=30). Subjects that meet all of the inclusion and none of the exclusion criteria will be invited to participate in the study.
Enrolled subjects will undergo bone marrow aspiration and intradiscal injection by an experienced orthopedic spine surgeon. Subjects will be followed for 1 year to evaluate the effects of the disc injection.
472 studies on the registry are indexed under Intervertebral Disc Degeneration; 100 are open to participants now.
This study's planned enrollment of 20 is below the median of 60 across 268 interventional studies indexed under Intervertebral Disc Degeneration.
Browse Intervertebral Disc Degeneration studies →Bone and Joint Clinic of Baton Rouge is the lead sponsor of 3 studies on the registry; none are open to participants now.
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MRI confirmed isolated lumbar disc degeneration OR
o If zygapophysial joint degeneration is present on MRI, subject must have failed intra-articular injection or medial branch block (\<50% pain relief) to be eligible for enrollment. PI will have final discretion as to whether the patient's symptoms originate from a single disc.
Exclusion Criteria:
Other: Autologous Bone Marrow Aspirate Concentrate (BMAC) Injection
Subjects will undergo bone marrow aspiration from the iliac crest. Bone marrow will be concentrated and injected into the symptomatic lumbar disc.
Change in Visual Analog Scale (VAS) Pain Score
The severity of back and leg pain will be evaluated using a 100 mm visual analog scale (VAS) where a higher number indicates greater pain.
Time frame: 1 day (Pre-injection) to 12 months post-injection
Change in Oswestry Disability Index
The Oswestry Disability Index (ODI) is the most commonly used patient reported outcome measure in patients with low back pain. The ODI score ranges from 0% to 100%. A higher score corresponds to a greater disability.
Time frame: 1 day (Pre-injection) to 12 months post-injection
BMAC injection survival
The number of subjects who do not proceed to surgery for their discogenic back pain and answer YES to " Are you satisfied with the outcome of this injection? OR NO to "Are you seeking any additional treatments for your discogenic back pain at this time?"
Time frame: 12 months post-injection
MRI evaluation of the degenerative disc
A modified Pfirrman grade will be assigned and used to assess changes in the disc pre-injection to 1 year post - injection
Time frame: 1 day (Pre-injection) and 12 months post-injection
CFU-F Analysis
Cell viability testing and CFU-F assay will be conducted on an aliquot from each subject's BMAC. Number of CFU-F from each patient will be used to correlate with patient reported outcomes.
Time frame: 1 Day of Injection
Started Apr 2019 (actual). Primary completion is estimated for Sep 2022, 41 months after the start.
Of 39 non-industry interventional studies with no phase under Intervertebral Disc Degeneration, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 63. This study's planned 41 months is below that.
Counting every sponsor, half of 85 studies reached it within 50 months; a quarter within 27 and three quarters within 72.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Intervertebral Disc Degeneration →
Bone and Joint Clinic of Baton Rouge