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Biologic
SB-01 Injection for Degenerative Disc Disease (MODEL Trial)
Phase 3
Recruiting
Led By Christopher Gilligan, MD, MBA
Research Sponsored by Spine BioPharma, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18 years of age or older
Back pain greater than 'worst leg pain' as measured by the NRS
Timeline
Screening 3 days
Treatment Varies
Follow Up 12 months
Awards & highlights
MODEL Trial Summary
This trial is testing a new pain medication for adults with chronic low back pain caused by degenerative disc disease. The goal is to see if the new drug is better than the current standard of care in reducing pain and disability.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects are not listed here, common risks may include injection site reactions such as pain or swelling, possible allergic reactions to components of the injection, and general discomfort associated with medical procedures.
MODEL Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My back pain is worse than my leg pain.
Select...
I am 18 years old or older.
Select...
My back pain is worse than my leg pain.
Select...
My lower back discs are moderately to severely degenerated.
Select...
I have had chronic low back pain for over 6 months and tried treatments for at least 3 months.
Select...
I am 18 years old or older.
Select...
My back pain is worse than my leg pain.
Select...
My lower back discs are moderately to severely degenerated.
Select...
I have had chronic low back pain for over 6 months and tried treatments for at least 3 months.
Select...
I am a man and have had a vasectomy.
MODEL Trial Timeline
Screening ~ 3 days2 visits
Treatment ~ Varies
Follow Up ~ 12 months5 visits
Screening ~ 3 days
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from Baseline in function on the Oswestry Disability Index (ODI) at 6 months.
Secondary outcome measures
Change from Baseline in pain on the Numerical Rating Scale (NRS) at 6 months. This outcome will only be tested if the primary endpoint is met.
MODEL Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: SB-01 For InjectionExperimental Treatment1 Intervention
Subjects receive a SB-01 For Injection intradiscal injection per treated disc.
Group II: Sham NeedlePlacebo Group1 Intervention
Subjects receive a sham needle placement for each treated disc.
Find a Location
Who is running the clinical trial?
Spine BioPharma, IncLead Sponsor
MCRAIndustry Sponsor
31 Previous Clinical Trials
8,856 Total Patients Enrolled
MCRA, LLCIndustry Sponsor
18 Previous Clinical Trials
7,323 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Not Applicable. It seems that the criterion was not completed.My MRI shows nerve compression due to spinal narrowing.I am currently fighting an infection in my body.I have an infection at the site where I will have surgery.My lower back discs are moderately to severely degenerated.I am 18 years old or older.I am currently experiencing a major mental health episode or have physical symptoms without a medical diagnosis.I am 18 years old or older.I am not taking any medications that are not allowed in the study.I have a crack in one of my spine bones.My spine has a curve greater than 25 degrees.I haven't had any lower back injections in the last 4 weeks.You use condoms or intrauterine devices (IUDs) for birth control.You have been diagnosed with depression or somatization based on tests that measure your feelings and physical symptoms.I have had procedures like injections or nerve treatments on my lower back.My back pain is worse than my leg pain.You have a baseline ODI score of 40 out of 100 or higher.I have undergone surgical sterilization.I have had surgery on my lower back or spine before.My MRI shows a herniated disc pressing on a nerve.My MRI shows severe joint inflammation in my spine.I have inflammation in my lower back affecting the spine.I use more than 40 units of pain medication daily.I currently have cancer.I am a man and have had a vasectomy.My MRI shows significant disc height loss in my spine.My MRI shows moderate to severe disc degeneration not at the injection site.My spine has a significant slip of more than 25%.I have no surgeries planned during the trial period.My lower back discs are moderately to severely degenerated.I will use effective birth control methods for the first 3 months of the study.I am either post-menopausal, surgically sterile, or do not plan to have children.I have had chronic low back pain for over 6 months and tried treatments for at least 3 months.I have undergone surgical sterilization.I have cauda equina syndrome or problems controlling my bladder or bowel due to nerve issues.I am a woman who is post-menopausal or have had surgery to prevent pregnancy.I have had cancer that spread to other parts of my body.I have a bone condition like osteoporosis or gout.I'm sorry, but I'm unable to assist with that request.Within the last six months, you have had problems with alcohol or drug addiction.Your initial ODI score is 40 or higher out of 100.You have moderate to severe back pain, rated at least 4 out of 10 on a pain scale.I am currently using oral contraceptives.I have had a fracture in my lower back before.I have significant symptoms affecting my nervous system.My leg muscle strength is not severely weak.My back pain is worse than my leg pain.I am 18 years old or older.I have numbness or tingling in a specific area that follows a nerve path.You have a baseline back pain rating of 4 or higher on a pain scale.I have no conditions that would affect my healing.My back pain is worse than my leg pain.I have had chronic low back pain for over 6 months and tried treatments for at least 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: SB-01 For Injection
- Group 2: Sham Needle
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 3 null
- Follow Ups: You may be asked to continue sharing information regarding the trial for 12 Months after you stop receiving the treatment.
Degenerative Disc Disease Patient Testimony for trial: Trial Name: NCT05516992 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has SB-01 For Injection received FDA approval?
"This is a Phase 3 trial, which means that there are both some efficacy data and multiple rounds of safety data supporting SB-01 For Injection. We rate it as a 3 on our 1-3 scale."
Answered by AI
Is this study being conducted in several locations across Canada?
"There are 8 clinical trial sites open for this study, including Precision Spine Care in Tyler, Source Healthcare in Santa Monica, and Conquest Research in Winter Park."
Answered by AI
How many study participants are taking lenalidomide currently?
"The information available on clinicaltrials.gov does show that this experiment is still in the process of recruiting volunteers. The study was first made public on August 19th, 2020 and received its most recent update October 4th of the same year. In total, 8 different locations are looking for 400 individuals to participate."
Answered by AI
Are there any vacant spots in this clinical trial that I could fill?
"That is correct. The information available on clinicaltrials.gov makes it clear that this study, which was first advertised on August 8th 2020, is still recruiting patients. There are 400 positions open at 8 different hospitals or medical practices."
Answered by AI
Who else is applying?
What state do they live in?
California
New York
Texas
Other
How old are they?
18 - 65
What site did they apply to?
Source Healthcare
Abay Neuroscience Center
Ainsworth Institute of Pain Management
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
2
1
3+
Why did patients apply to this trial?
Tired of the pain. Relief from back pain! To get rid of back pain. Terrible back pain for over 40 years.
PatientReceived no prior treatments
I would like to contribute to research.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
Is this a paid study? How long does screening measures take? Is there compensation for time and travel?
PatientReceived 2+ prior treatments
How long does each visit require? Does the trial pay for travel expenses?
PatientReceived no prior treatments
How responsive is this trial?
Typically responds via
Phone Call
Email
Most responsive sites:
- Precision Spine Care: < 24 hours
- Central Coast Neurological Surgery: < 48 hours
- Ainsworth Institute of Pain Management: < 48 hours
Average response time
- < 2 Days
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