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Biologic
BRTX-100 for Chronic Lumbar Disc Disease
Phase 2
Recruiting
Research Sponsored by BioRestorative Therapies
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No evidence of contraindications to the procedure such as pregnancy, active infection, bleeding disorder, or metastatic cancer.
Failure of supervised therapy and education
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through week 104 / early termination
Awards & highlights
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.
Who is the study for?
This trial is for adults aged 18 to 60 with chronic lower back pain due to lumbar disc disease, who have not responded to at least six months of conservative treatments. Participants should have specific MRI findings and a history of back pain provoked by activities like sitting or bending. Pregnant women, those with severe spinal conditions, recent steroid injections, drug abuse history, or certain medical conditions are excluded.Check my eligibility
What is being tested?
The study tests BRTX-100 against saline in a double-blind setup where neither the participants nor the researchers know who receives which treatment. It's randomized and involves one dose to see if BRTX-100 can help relieve chronic lumbar disc disease symptoms better than a saline placebo.See study design
What are the potential side effects?
While the side effects aren't listed here explicitly, potential risks may include reactions at the injection site such as pain or swelling, infection risk from injections, allergic reactions to components in BRTX-100 or DMSO (a solvent), and general discomfort.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not pregnant, have no infections, bleeding disorders, or cancer that has spread.
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My condition did not improve despite following medical advice and attending educational sessions.
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My back pain significantly affects my daily life but I'm not completely disabled.
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I don't have significant pain below my waist without back pain.
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My average back pain last week was moderate to severe.
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I am between 18 and 60 years old.
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I have had lower back pain for at least 6 months.
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My leg pain is not caused by nerve compression.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline through week 104 / early termination
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through week 104 / early termination
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Primary Efficacy Measures
Primary Safety Measures
Secondary outcome measures
Oswestry Disability Index for Functional Assessment -- Changes from Baseline in function as assessed with the Oswestry Disability Index through Week 52.
Visual Analogue Scale for Pain Assessment - Changes from Baseline in pain as assessed with the VAS score through Week 52
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active Treatment- BRTX-100Experimental Treatment1 Intervention
BRTX-100 consists of a population of hypoxic-cultured bone marrow mononuclear cells highly enriched in mesenchymal stem cells from autologous bone marrow with autologous platelet lysate.
Group II: SalinePlacebo Group1 Intervention
Isotonic saline will be used as a control in this study. Drug: saline (0.9% sodium chloride).
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Who is running the clinical trial?
BioRestorative TherapiesLead Sponsor
Jason Lipitz, MDStudy ChairBioRestorative Therapies
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Active Treatment- BRTX-100
- Group 2: Saline
Awards:
This trial has 0 awards, including: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: 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.
Lumbar Disc Disease Patient Testimony for trial: Trial Name: NCT04042844 — Phase 2
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