What is BRTX-100 studying for chronic lumbar disc disease?

BRTX-100 is being studied to evaluate its safety and initial effects when injected into the discs of adults with chronic lumbar disc disease. This trial aims to understand if a single dose of BRTX-100 can be safely given and how it may affect back pain and disc condition over time. The study is sponsored by BioRestorative Therapies.

Who may be eligible for this lumbar disc disease clinical trial?

Adults aged 18 or older with chronic lower back pain and diagnosed degenerative disc disease may be eligible. Participants should have tried conservative treatments without sufficient relief and meet specific pain and imaging criteria. Both men and women can participate. Please review eligibility criteria for more details.

Is there any cost to participate in this lumbar disc disease clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or accommodation needs.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

ID04042844

Phase 2 Double-Blind Study Evaluating a Single Intradiscal Injection of BRTX-100 in Adults With Chronic Lumbar Disc Disease

Led by BioRestorative Therapies · Updated on 2025-08-26

Participants Needed

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and preliminary effects of a single intradiscal injection of BRTX-100 in adults with chronic lumbar disc disease, a condition causing back and leg pain due to degeneration of spinal discs confirmed by imaging and clinical evaluation. This is a phase 2, double-blind, randomized study with controlled and blinded assessments to compare BRTX-100 against a sham procedure treatment. Participants will be randomly assigned to receive either BRTX-100, which contains specially cultured stem cells from their own bone marrow combined with platelet lysate, or a control group receiving a sham procedure with saline. Those in the treatment group will undergo bone marrow collection to prepare the BRTX-100 injection, while the control group will have bone marrow and blood collected but will not receive the active injection. The study includes a Safety Run-In phase with close monitoring of the first four treated participants before continuing the randomized phase. Follow-up visits will occur at weeks 2, 12, 26, 52, and 104 or early termination. During the study, participants will be monitored through physical exams, lab tests, and safety assessments to track any adverse effects and evaluate treatment impact. Primary safety measures will be assessed from baseline through week 104, and efficacy will be evaluated through week 52. The study aims to gather detailed information on safety and initial effectiveness while participants continue regular evaluations over two years, with careful oversight by medical monitors and a data safety board.

CONDITIONS

Brief Title

A Single Dose of BRTX 100 for Patients With Chronic Lumbar Disc Disease (cLDD)

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Age 18 years or older at the time of consent
Current diagnosis of chronic lumbar disc disease with back and/or radicular pain and disc degeneration confirmed by history, exam, and imaging
Chronic lower back pain lasting at least 6 months
Pain triggered by activities such as sitting, bending, lifting, twisting, coughing, sneezing, or Valsalva maneuvers
Failure to improve after at least 6 months of conservative back pain treatments and supervised therapy
Average low back pain rating between 40 and 80 mm on a visual analog scale
Oswestry Disability Index score between 30 and less than 90 on a 100-point scale
No significant localized pain below the beltline without lumbar pain component
Non-radicular thigh or leg pain if present
No prevailing facet joint involvement confirmed by diagnostic blocks or injections within 12 months
Degenerative disc disease with specific MRI findings including modified Pfirrmann score 1 to 7, Modic Grade I or II changes, and maintained disc height
Discography performed if needed to identify symptomatic disc
Willing and able to provide written informed consent
No contraindications such as pregnancy, active infection, bleeding disorders, or metastatic cancer

You will not qualify if you...

Spinal deformities such as scoliosis ≥ 20 degrees, spondylolysis, significant retrolisthesis or spondylolisthesis
Disc extrusions, sequestered fragments, facet cysts, or moderate to severe spinal stenosis
Grade V annular fissure on discography
Radiographic evidence of Modified Pfirrmann Grade 8 or higher
Bleeding disorders or required uninterrupted anticoagulation
Platelet count ≤ 100,000 or INR ≥ 1.5
Extreme obesity with BMI ≥ 40
Clinically relevant spinal instability on flexion-extension films
Previous lumbosacral spine surgery or certain interventional treatments
Acute or chronic spine fractures
Recent epidural steroid injections within 1 month
Planned NSAID use within 72 hours prior to treatment
Known allergy to dimethyl sulfoxide (DMSO)
Active significant non-lumbosacral orthopedic pain, widespread myofascial pain
Prior investigational cellular or biological therapy within 6 months or planned participation in such trials
History of alcohol or drug abuse within 6 months
Poorly controlled psychological or somatic disease impacting outcomes
Barriers to study compliance
Known autoimmune diseases affecting musculoskeletal or neurological systems
Chronic immunosuppression
Positive tests for hepatitis C or HIV
Pregnancy, lactation, or inadequate contraception in women of childbearing potential
Abnormal laboratory values affecting safety
Other active medical or psychiatric illnesses
Inability to comply with study protocol
Active workers compensation or litigation related to back pain
History of drug or alcohol abuse or noncompliance with controlled substances
Long-term daily opioid use ≥ 30 MME

Research Team

Francisco Silva

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Phase 2 Double-Blind Study Evaluating a Single Intradiscal Injection of BRTX-100 in Adults With Chronic Lumbar Disc Disease

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria