NCT04042844 · BioRestorative Therapies
A Single Dose of BRTX 100 for Patients With Chronic Lumbar Disc Disease (cLDD)
What this study is about
This is a where neither patients nor doctors know which treatment is given, controlled, randomly assigned study with blinded assessments using a single dose. Subjects that have a current diagnosis of chronic lumbar disc disease and meet eligibility criteria will be enrolled.
View original scientific description
This is a double-blind, controlled, randomized study with blinded assessments using a single dose. Subjects that have a current diagnosis of chronic lumbar disc disease and meet eligibility criteria will be enrolled.
Interventions
BIOLOGICAL
BRTX-100
Hypoxic cultured mesenchymal stem cells (MSCs) from autologous bone marrow with autologous platelet lysate.
DRUG
Saline
Sodium Chloride (0.9%) intravenous infusion preparation is a sterile and non-pyrogenic solution
Primary outcome measures
Primary Safety Measures
Time frame: Baseline through Week 104 / Early Termination
Report of adverse events (AEs), clinical review and questionnaires for pain, disability and quality of life at Baseline through Week 104/ Early Termination * Vital Signs * Physical Examination * Laboratory Evaluation (hematology and chemistry) * Clinical review of MRI changes from Baseline to Week 104 (MRI density measurements in T2 weighted images performed at Baseline, Week 52 and Week 104 with predetermined MRI rating scores)
Primary Efficacy Measures
Time frame: Baseline through Week 52
* VAS for Pain Assessment * ODI for Functional Assessment Primary Efficacy Endpoint: Clinical response, defined as at least a 30% decrease in pain as measured on the VAS scale and at least a 30% increase in function based on the ODI at Week 52 as compared to baseline.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- A subject is eligible for inclusion if all the following criteria are met: 1. A high index of suspicion for discogenic pain, (i.e., painful degenerative disc(s) with or without protrusions less than or equal to 5 mm) 1. Chronic Lower Back Pain for at least 6 months 2. Pain commonly provoked by prolonged sitting, forward bending, lifting, twisting, coughing, sneezing, or Valsalva maneuvers 3. Failure of at least 6 months of conservative back pain care (can include any or all of the following: rest, anti-inflammatory medication, analgesics, narcotics, epidural injections or selective nerve root injections at the target level, facet joint injections, muscle relaxers, massage, acupuncture, chiropractic care) 4. Failure of supervised therapy (such as physical therapy) 5. Screening of ≥ 40 mm and ≤ 80 mm on low back pain visual analog scales (VAS) (average pain in the last week) 6. Screening Oswestry Disability Index (ODI) score ≥ 30 and \< 90
Where
- Birmingham, Alabama
- Santa Monica, California
- Walnut Creek, California
- Greenwood Village, Colorado
- Fort Lauderdale, Florida
- Jacksonville, Florida
- St. Petersburg, Florida
- Tampa, Florida
- Winter Park, Florida
- New York, New York
- Winston-Salem, North Carolina
- Cleveland, Ohio
And 6 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 26, 2025 · Source of record for eligibility and locations