SB-01 Injection for Degenerative Disc Disease

(MODEL Trial)

Recruiting at 42 trial locations

Overseen By Malisa Agard, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Spine BioPharma, Inc

Disqualifiers: Chronic narcotic use, Depression, Extreme obesity, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

417 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the study is to confirm the safety and effectiveness of SB-01 For Injection in adult patients with chronic low back pain and related disability due to Lumbar Degenerative Disc Disease. The primary effectiveness hypothesis is superiority of the investigational product relative to control in terms of the percentage of subjects improving in pain-related disability.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you must stop taking your current medications, but it mentions that certain medications are prohibited. It's best to discuss your current medications with the trial team to see if any adjustments are needed.

What data supports the effectiveness of the treatment SB-01 Injection for Degenerative Disc Disease?

Research on osteogenic protein-1 (OP-1), a component similar to SB-01, shows it can reduce degeneration and pain in animal models, suggesting potential benefits for degenerative disc disease. ^{1 2 3 4 5}

How is the SB-01 treatment for Degenerative Disc Disease different from other treatments?

The SB-01 treatment for Degenerative Disc Disease is unique because it may involve a novel approach similar to NTG-101, which has shown promising results in reducing inflammation and promoting tissue repair in degenerative discs, potentially offering benefits over traditional treatments like spinal steroid injections that lack lasting improvement. ^{1 6 7 8 9}

Research Team

Christopher Gilligan, MD

Principal Investigator

Brigham and Women's Spine Center

Eligibility Criteria

Adults over 18 with chronic low back pain from Lumbar Degenerative Disc Disease, confirmed by MRI. Participants must have tried conservative treatment for at least 3 months and be willing to use effective contraception if of childbearing potential. Exclusions include prior spine surgery, certain MRI findings like disc herniation or severe facet arthrosis, chronic narcotic use, systemic infections, active malignancy, pregnancy, and involvement in other clinical trials.

Inclusion Criteria

Not Applicable. It seems that the criterion was not completed.

My lower back discs are moderately to severely degenerated.

Willing and able to comply with this protocol and be available for the entire duration of the study, including ability to access the internet

Exclusion Criteria

MRI evidence of significant stenosis of the central canal at any level, determined by the independent radiologic central lab

My MRI shows nerve compression due to spinal narrowing.

I am currently fighting an infection in my body.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive SB-01 For Injection or sham needle placement for lumbar degenerative disc disease

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• SB-01 For Injection
• Sham Needle

Trial Overview The trial is testing the safety and effectiveness of SB-01 For Injection compared to a sham needle (placebo) in reducing pain-related disability due to lumbar degenerative disc disease. The goal is to see if patients receiving SB-01 experience more significant improvements than those receiving the placebo.

Participant Groups

Group I: SB-01 For Injection Experimental Treatment 1 Intervention

Subjects receive a SB-01 For Injection intradiscal injection per treated disc.

Group II: Sham Needle Placebo Group 1 Intervention

Subjects receive a sham needle placement for each treated disc.

Who Is Running the Clinical Trial?

Spine BioPharma, Inc

Lead Sponsor

Trials

1

Recruited

420+

MCRA

Industry Sponsor

Trials

40

Recruited

11,100+

MCRA, LLC

Industry Sponsor

Trials

19

Recruited

7,500+

References

1. United States pubmed.ncbi.nlm.nih.gov

Low-pressure positive Discography in subjects asymptomatic of significant low back pain illness. [2016]

2. United States pubmed.ncbi.nlm.nih.gov

Osteogenic protein-1 (osteogenic protein-1/bone morphogenetic protein-7) inhibits degeneration and pain-related behavior induced by chronically compressed nucleus pulposus in the rat. [2019]

3. Germany pubmed.ncbi.nlm.nih.gov

[Keel-based lumbar total disk replacement: Prodisc-L and Prodisc-O]. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Intradiscal injections of osteogenic protein-1 restore the viscoelastic properties of degenerated intervertebral discs. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

The 1-Year Results of Lumbar Transforaminal Epidural Steroid Injection in Patients with Chronic Unilateral Radicular Pain: The Relation to MRI Findings and Clinical Features. [2017]

6. United States pubmed.ncbi.nlm.nih.gov

The effect of spinal steroid injections for degenerative disc disease. [2013]

7. England pubmed.ncbi.nlm.nih.gov

A comparative study of mesenchymal stem cell transplantation and NTG-101 molecular therapy to treat degenerative disc disease. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Treatment of lumbar degenerative disc disease-associated radicular pain with culture-expanded autologous mesenchymal stem cells: a pilot study on safety and efficacy. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

Percutaneous cement discoplasty for the treatment of advanced degenerative disk disease in elderly patients. [2022]