716001 - Human Bone Marrow Concentrate-derived Mesenchymal Stem Cells for Treatment of Low Back Pain: Patient Reported Outcomes Through One Year

Thursday, February 27, 2020

2:10 PM – 2:15 PM

Location: 208

Participants should be aware of the following financial/non-financial relationships:

Colin Haines, MD: 4WEB Medical (Individual(s) Involved: Self, Products/Services: Consultancy): ; Globus Medical, Inc. (Individual(s) Involved: Self, Products/Services: Consultancy): ; Medtronic Inc. (Individual(s) Involved: Self, Products/Services: Consultancy): ; Spineart USA, Inc. (Individual(s) Involved: Self, Products/Services: Consultancy):

Niteesh Bharara, MD: I do not have any relevant financial / non-financial relationships with any proprietary interests.

Sawyer P. Mills: I do not have any relevant financial / non-financial relationships with any proprietary interests.

Christopher Good, MD: K2M Stryker Spine (Individual(s) Involved: Self, Products/Services: Consulting, advisory board): Consulting, advisory board; Medtronic (Individual(s) Involved: Self, Products/Services: Consulting, Advisory Board): Consulting, advisory board

Christopher J. Gorini, PhD: Disclosure information not submitted.

Thomas C. Schuler, MD: I do not have any relevant financial / non-financial relationships with any proprietary interests.

Ehsan J. Jazini, MD: Medtronic (Individual(s) Involved: Self, Products/Services: Cortical screw): Consultant

Thomas T. Nguyen, MD: I do not have any relevant financial / non-financial relationships with any proprietary interests.

Background and

Purpose: Autologous bone marrow concentrate (BMC) intervertebral disc injections have the potential to provide a significant amount of pain relief for those suffering from degenerative disc disease and/or discogenic pain. Injections of mesenchymal stem cells (MSC) and other growth factors harbored within BMC can provide a viable alternative to surgical treatments, while decreasing pain levels and improving quality of life. We analyzed patient reported outcomes, as a means of investigating regenerative medicine as an alternative to traditional treatment options for degenerative disc disease and discogenic pain

Methods: This is a prospective study in collaboration with a spine clinic. Oswestry Disability Index (ODI), EQ-5D-5L, and Visual Analog Scale (VAS) scores were reported for patients at baseline, 6 month, and 1 year post-intervention. 32 patients (25 male, 7 female, age 20-68) suffering from degenerative disc disease and discogenic low back pain (as confirmed by discography) who failed 6 months of non-operative treatment. Number of levels injected using BMC varied between 1 and 6 (average of 2.7). Patient-reported outcome metrics from 32 patients with minimum 6 months post-treatment follow up (n=25) and up to 1 year post-treatment (n= 17) were captured in this data set.

Results: There was a significant decrease in patient-reported pain in all 32 patients as compared to baseline levels over all time points. At 6 months post-treatment, patient ODI significantly decreased by 38.2% ± 0.104 (p> 0.001, n=25). At 12 months post-injection, there was a significant decrease in ODI by 57.8% ± 0.08 compared to baseline levels (p> 0.001, n=17) with raw scores decreasing by 8.12 ± 1.44, which exceeded the minimum clinically important difference (MCID). Patient-reported VAS back scores also significantly decreased by 17.47% ± 0.2 (p> 0.005, n=25) after 6 months compared to baseline. After 1 year post-injection, we show VAS back scores significantly decrease by 12.7% ± 0.23 (p> 0.01, n=17) and a raw score decrease of 2.188 ± 0.732, exceeding the MCID. There was a significant increase of 19.1% ± 0.06, (p> 0.005, n=25) in quality of life (via EQ-5D-5L reports) at the 6 month follow-up time point, as compared to baseline levels and, after 12 months post-treatment, EQ-5D-5L scores significantly increased by 21.6% ± 0.03 (p> 0.005, n=17) with a raw score exceeding the reported MCID.

Conclusions: Results indicate BMC may be a viable, minimally invasive treatment option for discogenic low back pain or lumbar degenerative disc disease. We report no adverse events related to either the aspiration or injection procedures of BMC, while patients reported significant decreases in pain levels and an improved quality of life sustained over one year following the procedure.

Presenting Author(s)

Niteesh Bharara, MD

Director of Regenerative Medicine
Virginia Spine Institute

Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.

Co-Author(s)

Colin Haines, MD

Spine Surgeon, Director of Research
Virginia Spine Institute

Disclosure: 4WEB Medical (Individual(s) Involved: Self, Products/Services: Consultancy): ; Globus Medical, Inc. (Individual(s) Involved: Self, Products/Services: Consultancy): ; Medtronic Inc. (Individual(s) Involved: Self, Products/Services: Consultancy): ; Spineart USA, Inc. (Individual(s) Involved: Self, Products/Services: Consultancy):
Sawyer P. Mills

Research Intern
National Spine Health Foundation

Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
Christopher Good, MD

Spine Surgeon, President
Virginia Spine Institute

Disclosure: K2M Stryker Spine : Consulting, advisory board (Status: Ongoing); Medtronic : Consulting, advisory board (Status: Ongoing)
Christopher J. Gorini, PhD

Research Director
National Spine Health Foundation

Disclosure: Disclosure information not submitted.
Thomas C. Schuler, MD

Spine Surgeon, CEO, and Founder
Virginia Spine Institute

Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.
Ehsan J. Jazini, MD

Spine Surgeon
Virginia Spine Institute

Disclosure: Medtronic : Consultant (Status: Ongoing)
Thomas T. Nguyen, MD

Interventional Pain Management Specialist
Virginia Spine Institute

Disclosure: I do not have any relevant financial / non-financial relationships with any proprietary interests.