Actively Recruiting
A Phase 2, Double-Blind, Controlled, Randomized Study to Evaluate the Safety and Preliminary Efficacy of a Single Dose Intradiscal Injection of BRTX-100 for Patients With Chronic Lumbar Disc Disease (cLDD)
Led by BioRestorative Therapies · Updated on 2025-08-26
99
Participants Needed
19
Research Sites
52 weeks
Total Duration
On this page
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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day
Participants receive a single intradiscal injection of either BRTX-100 or a sham saline injection after bone marrow and blood harvest procedures.
1 treatment visit (in-person)
Duration - Up to 104 weeks
Participants return for safety and efficacy assessments at scheduled visits following treatment.
Visits at Week 2, Week 12, Week 26, Week 52, and Week 104 or early termination (in-person)
Trial Site Locations
Total: 19 locations
1
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, United States, 35235
Withdrawn
2
Source Healthcare
Santa Monica, California, United States, 90403
Actively Recruiting
3
Boomerang Healthcare
Walnut Creek, California, United States, 94598
Actively Recruiting
4
Denver Back Pain Specialists, LLC
Greenwood Village, Colorado, United States, 80111
Actively Recruiting
5
Cantor Spine Institute
Fort Lauderdale, Florida, United States, 33306
Withdrawn
6
Coastal Health
Jacksonville, Florida, United States, 32257
Actively Recruiting
7
Pain Relief Centers
St. Petersburg, Florida, United States, 33709
Actively Recruiting
8
Tampa Pain Relief Center
Tampa, Florida, United States, 33603
Actively Recruiting
9
Florida Pain Relief Center
Tampa, Florida, United States, 33614
Actively Recruiting
10
Conquest Research
Winter Park, Florida, United States, 32789
Actively Recruiting
11
Northwell Health
New York, New York, United States, 10022
Actively Recruiting
12
The Center of Clinical Research, LLC
Winston-Salem, North Carolina, United States, 27103
Actively Recruiting
13
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
14
Clinical Investigations LLC
Edmond, Oklahoma, United States, 73013
Withdrawn
15
Coastal Carolina Research Center
North Charleston, South Carolina, United States, 29406,
Withdrawn
16
Science Connections
Austin, Texas, United States, 78758
Actively Recruiting
17
NCP Center for Clinical Research and Innovation
Houston, Texas, United States, 77008
Actively Recruiting
18
Precision Spine Care
Tyler, Texas, United States, 75701
Withdrawn
19
Virginia iSpine Physicians
Richmond, Virginia, United States, 23235
Actively Recruiting
Research Team
F
Francisco Silva
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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