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BRTX-100 for Chronic Lumbar Disc Disease
Study Summary
This trial is testing a new medication for chronic lumbar disc disease. The subjects have back and/or radicular pain with degeneration of the disc, confirmed by patient history, physical examination, and radiographic measures.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- My discography test showed a Grade V annular fissure.I am on long-term medication to suppress my immune system.My condition did not improve despite following medical advice and attending educational sessions.I have had surgery on my lower back before.I have been diagnosed with degenerative disc disease.I suspect my back pain is due to a degenerating disc.My back pain significantly affects my daily life but I'm not completely disabled.I don't have significant pain below my waist without back pain.My average back pain last week was moderate to severe.I am not pregnant, have no infections, bleeding disorders, or cancer that has spread.I am between 18 and 60 years old.I have had lower back pain for at least 6 months.My MRI shows I have severe spine issues like herniated discs or spinal narrowing.I have a recent or old fracture in my lower back.I have significant pain in areas other than my lower back, like my hips, knees, or neck.I have had a steroid injection in my lower back within the last month.I plan to use NSAIDs within 3 days before starting the study treatment.I experience widespread and unclear muscle pain.I have an autoimmune disease like lupus.I have a mental or physical health condition that isn't well-managed.I am currently receiving workers compensation or involved in a no-fault case for my lower back pain.I experience pain when sitting for long, bending, lifting, twisting, or during coughs and sneezes.I have tried various back pain treatments for over 6 months without success.I have been using opioids daily for a long time.My leg pain is not caused by nerve compression.I had a spine injection test in the last year showing no major joint issues.My worst disc problem matches the one causing me the most pain.I have a significant spinal curve or slippage confirmed by an MRI or X-ray.I have a bleeding disorder.I am on blood thinners that cannot be stopped for medical procedures.I have had stem cell therapy or a similar treatment for my lower back disc.I haven't had experimental treatments or plan to join another stem cell trial within 2 years.
- Group 1: Active Treatment- BRTX-100
- Group 2: Saline
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does BRTX-100 pose any health risks to patients?
"Using our internal rating scale of 1-3, BRTX-100 scored a 2 due to the availability of preliminary safety data but no efficacy information."
Is the age limitation for this trial below 70 years?
"This trial has set 18 years old as the lower limit and 60 years old as the upper limit for participation eligibility."
What is the extent of participation in this experiment?
"To complete this clinical trial, the sponsor BioRestorative Therapies must recruit a total of 99 participants who satisfy all entry criteria. This research program will take place across multiple sites such as Florida Pain Relief Center in Tampa and Clinical Investigations LLC in Garden Grove."
Is it possible to register as a participant in this research endeavor?
"This clinical trial has vacant spaces for ninety-nine individuals aged between 18 and 60 who are suffering from lumbar disc disease. To be eligible, participants must manifest a high index of suspicion for discogenic pain (e.g., painful degenerative discs with or without protrusions < 5 mm), chronic lower back pain spanning at least six months, an absence of localized yet significant discomfort below the beltline (i.e., potential sacroiliac joint affliction) unaccompanied by lumbar distress; typically provoked by extended sitting, forward bending, lifting, twisting, coughing/sneezing/Valsalva maneuvers"
Are researchers currently recruiting participants for this experiment?
"As confirmed on clinicaltrials.gov, recruitment for this medical trial is ongoing. It was first announced on the 30th June 2022 and underwent an update as recently as 20th October of same year."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
What questions have other patients asked about this trial?
How responsive is this trial?
Typically responds via
Average response time
- < 2 Days
Most responsive sites:
- Clinical Investigations LLC: < 24 hours
- Denver Back Pain Specialists, LLC: < 48 hours
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