A Prospective Study of Clinical Outcomes Following a Single Intradiscal Injection of Bone Marrow Aspirate Concentrate (BMAC) for Single Level Discogenic Low Back Pain
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|ClinicalTrials.gov Identifier: NCT03912454|
Recruitment Status : Enrolling by invitation
First Posted : April 11, 2019
Last Update Posted : July 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Degenerative Disc Disease Spine Degeneration||Other: Autologous Bone Marrow Aspirate Concentrate (BMAC) Injection||Not Applicable|
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.
The study population will consist of up to 20 patients aged 18- 60 with unresolved low back pain attributable to single level 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Study of Clinical Outcomes Following a Single Intradiscal Injection of Bone Marrow Aspirate Concentrate (BMAC) for Single Level Discogenic Low Back Pain|
|Actual Study Start Date :||April 8, 2019|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||September 2021|
|Experimental: BMAC Injection||
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 [ Time Frame: 1 day (Pre-injection) to 12 months post-injection ]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.
- Change in Oswestry Disability Index [ Time Frame: 1 day (Pre-injection) to 12 months post-injection ]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.
- BMAC injection survival [ Time Frame: 12 months post-injection ]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?"
- MRI evaluation of the degenerative disc [ Time Frame: 1 day (Pre-injection) and 12 months post-injection ]A modified Pfirrman grade will be assigned and used to assess changes in the disc pre-injection to 1 year post - injection
- CFU-F Analysis [ Time Frame: 1 Day of Injection ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03912454
|United States, Louisiana|
|Bone and Joint Clinic of Baton Rouge|
|Baton Rouge, Louisiana, United States, 70808|