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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

Must not have

Presence of a Grade V annular fissure on discography in a subject for whom provocation discography has been performed

Required chronic immunosuppression

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through week 104 / early termination

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My discography test showed a Grade V annular fissure.

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I am on long-term medication to suppress my immune system.

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I have had surgery on my lower back before.

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My MRI shows I have severe spine issues like herniated discs or spinal narrowing.

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I have a recent or old fracture in my lower back.

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I have significant pain in areas other than my lower back, like my hips, knees, or neck.

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I have an autoimmune disease like lupus.

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I am currently receiving workers compensation or involved in a no-fault case for my lower back pain.

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I have been using opioids daily for a long time.

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I have a significant spinal curve or slippage confirmed by an MRI or X-ray.

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I have a bleeding disorder.

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I am on blood thinners that cannot be stopped for medical procedures.

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I have had stem cell therapy or a similar treatment for my lower back disc.

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I haven't had experimental treatments or plan to join another stem cell trial within 2 years.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through week 104 / early termination for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Primary Efficacy Measures

Primary Safety Measures

Secondary study objectives

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).

0 / 22Eligibility criteria met