713538 - Clinical Investigation of the Safety and Preliminary Results of Cellularized Allograft Disc Matrix for the Treatment of Symptomatic Lumbar Disc Degeneration

Thursday, February 27, 2020

8:00 AM – 8:05 AM

Location: Ballroom B

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

Richard D. Guyer, MD: Aesculap (Individual(s) Involved: Self, Products/Services: implants): Consultant; Alphatec (Individual(s) Involved: Self, Products/Services: implants): Royalties; Crocker Technologies (Individual(s) Involved: Self, Products/Services: implatns): stock options; DePuy/Synthes (Individual(s) Involved: Self, Products/Services: Implants): consulting and teaching; K2M (Individual(s) Involved: Self, Products/Services: implants): scientific advisory board; MiMedx (Individual(s) Involved: Self, Products/Services: implants): stock options; Nanovis (Individual(s) Involved: Self, Products/Services: implants): stock options; Orthofix (Individual(s) Involved: Self, Products/Services: implants): Consultant; Spinal Kinetics Inc. (Individual(s) Involved: Self, Products/Services: implants): stock options; Spinal Motion (Individual(s) Involved: Self, Products/Services: implant): stock

Scott L. Blumenthal, MD: Aesculap (Individual(s) Involved: Self, Products/Services: Implants): Royalties, consulting, speaking/teaching; Bayliss (Individual(s) Involved: Self, Products/Services: Implants): Speaking/teaching; Centinel Spine (Individual(s) Involved: Self, Products/Services: Implants): Stock/options; Fziomed (Individual(s) Involved: Self, Products/Services: Implants): stock/options and scientific advisory board; Orthofix (Individual(s) Involved: Self, Products/Services: Implants): Consulting; Sites Medical (Individual(s) Involved: Self, Products/Services: Implants): Consulting; Vertera (Individual(s) Involved: Self, Products/Services: Implants): Consulting; Vertiflex (Individual(s) Involved: Self, Products/Services: Implants): scientific advisory board, speaking/teaching

Douglas Beall, MD: ReGelTech (Individual(s) Involved: Self, Products/Services: Hydrafil): Research Support; Spine Biopharma (Individual(s) Involved: Self, Products/Services: Remedisc): Research Support

Gregory Wilson, MD: Disclosure information not submitted.

Randolph Bishop, MD: Disclosure information not submitted.

William Tally, MD: Vivex Biologics (Individual(s) Involved: Self, Products/Services: Research support): Research support - financial support for research staff

Thomas Temple, MD: Disclosure information not submitted.

Timothy Ganey, PhD: Vivex Biologics (Individual(s) Involved: Self, Products/Services: Employee):

Donna D. Ohnmeiss, DrMed: I do not have any relevant financial / non-financial relationships with any proprietary interests.

Background: There has been much interest in addressing degenerative changes in intervertebral discs at a tissue level, but very little clinical data is available. One method, using cellularized allograft disc matrix, was the topic of this study.

Purpose: The purpose of the study was to investigate the safety and preliminary outcomes of using an injection of cellularized nucleus allograft disc matrix to treat painful lumbar disc degeneration.
Study design/Setting: Data are from a prospective, randomized, controlled trial.
Eligible population: This study assessed the first 24 patients of the larger study (224 patients) for safety and preliminary outcomes. Primary study selection criteria included >6 months of back pain (with or without leg pain) related to disc degeneration, Pfirrmann score of 3-6 based on MRI, no prior lumbar surgery, and no moderate/severe stenosis. Patients could be treated at 1 or 2 levels.
Length of follow-up: Patients in this safety study were followed for 12 months.
Outcome measures: The primary outcome assessment for safety was adverse event (AE) monitoring. Primary clinical outcomes were visual analog scales (VAS) evaluating back and leg pain, and the Oswestry Disability Index (ODI) assessed at 1, 6, and 12 months.

Methods: Following IRB approval, a prospective, randomized 3-arm study was initiated. Patients were randomized in a 2:1:1 ratio to receive allograft, placebo (saline injection), or continued conservative treatment. Randomization of these first 24 patients was: cellular allograft (16), placebo (4), and continued conservative care (4). Patients who continued conservative care were offered the option to crossover to allograft treatment at 3 months if they did not have adequate improvement. Safety was assessed by the incidence and severity of AEs and clinically relevant changes in laboratory tests. The safety committee evaluated complications including infections, inflammation, additional interventions, and reviewed MRI studies up to 12 months following treatment.

Results: Assessment at 30 days found no safety incidents reported. There were no reports of infection or inflammation, no patient withdrew from the study, and none underwent surgical intervention during the 12-month period. A few subjects reported transient pain after the injection that was managed with medication. VAS back pain scores were reduced in all treated patients. In the allograft group, pain scores decreased from 58.3 to 9.8 and in the placebo (saline) decreased from 60.0 to 27.0. All patients randomized to continued conservative management crossed over to allograft due to persistent symptoms. After crossover their pain scores decreased from 55.0 to 6.0. On the ODI scores, the allograft patients decreased from 54.7 to 12.8; placebo patients decreased from 50.4 to 17.5, and after crossover and allograft injection, conservative care ODI scores decreased from 65.5 to 20.0. Figure 1 shows increased nucleus signal at 12 months post-op.

Conclusions: In this small safety and preliminary outcome series, injection of allograft matrix was not associated with adverse events. Allograft injection was associated with improved pain and ODI scores in patients randomized to the treatment and those who crossed over to it after failure of continued conservative treatment. Follow-up of the large series is underway.

Presenting Author(s)

Richard D. Guyer, MD

Co-Director Center for Disc Replacement, Fellowship Director
Center for Disc Replacement at Texas Back Institute

Disclosure: Aesculap : Consultant (Status: Ongoing); Alphatec : Royalties (Status: Ongoing); Crocker Technologies : stock options (Status: Ongoing); DePuy/Synthes : consulting and teaching (Status: Ongoing); K2M : scientific advisory board (Status: Ongoing); MiMedx : stock options (Status: Ongoing); Nanovis : stock options (Status: Ongoing); Orthofix : Consultant (Status: Ongoing); Spinal Kinetics Inc. : stock options (Status: Ongoing); Spinal Motion : stock (Status: Ongoing)

Co-Author(s)

Scott L. Blumenthal, MD

Co-Director
Center for Disc Replacement at Texas Back Institute

Disclosure: Aesculap : Royalties, consulting, speaking/teaching (Status: Ongoing); Bayliss : Speaking/teaching (Status: Ongoing); Centinel Spine : Stock/options (Status: Ongoing); Fziomed : stock/options and scientific advisory board (Status: Ongoing); Orthofix : Consulting (Status: Ongoing); Sites Medical : Consulting (Status: Ongoing); Vertera : Consulting (Status: Ongoing); Vertiflex : scientific advisory board, speaking/teaching (Status: Ongoing)
Douglas Beall, MD

Chief of Services
Interventional Musculoskeletal Radiology

Disclosure: ReGelTech : Research Support (Status: Ongoing); Spine Biopharma : Research Support (Status: Ongoing)
Gregory Wilson, MD

Invictus Healthcare System

Disclosure: Disclosure information not submitted.
Randolph Bishop, MD

Neurological and Spine Institute

Disclosure: Disclosure information not submitted.
William Tally, MD

Surgeon
Athens Orthopedic Clinic

Disclosure: Vivex Biologics : Research support - financial support for research staff (Status: Ongoing)
Thomas Temple, MD

Nova Southeastern University

Disclosure: Disclosure information not submitted.
Timothy Ganey, PhD

Chief Technology Officer
VIVEX Biologics

Disclosure: Vivex Biologics (Individual(s) Involved: Self, Products/Services: Employee):
Donna D. Ohnmeiss, DrMed

Researcher
Texas Back Institute Research Foundation

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