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Tests treatment safety and results for Osteoarthritis of Facet Joint of Lumbar Spine
Official title Safety of Adipose-derived Regenerative Cells Injection for Treatment of Osteoarthritis of the Facet Joint
ClinicalTrials.gov ID: NCT03513731
What this study is testing
What is Corticosteroid injection?
Corticosteroid injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for osteoarthritis of facet joint of lumbar spine.
Also referred to as steroid injection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a prospective, randomized, active controlled, single site safety and efficacy study in subjects suffering from chronic lumber back pain due to facet joint osteoarthritis comparing a single ADRC injection generated with the Transpose® RT system into the facet joint.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Male and female people, between 18 and 75 years of age.
- Have documented the diagnosis of facet joint osteoarthritis from L1 to S1 in the opinion of the investigator.
- Have a documented diagnosis of symptomatic facet joint syndrome is defined as the following (subject must meet all the listed conditions):
- Chronic low back pain for at least 6 months.
- Have failed 3 months of conservative back pain care. (Conservative treatment regimens may include any or all of the following: initial rest...
You likely can't join if
- Female people who are pregnant or nursing, or women planning to become pregnant within 12 months following treatment.
- Females of childbearing age who have not used or do not plan to use acceptable birth control measures, for the duration of the study. Oral, injected...
- Extreme obesity, as defined by NIH Clinical Guidelines Body Mass Index (BMI \> 40)
- Any lumbar intradiscal injection, including steroids, at the symptomatic or adjacent discs less than 3 months prior to treatment injection, except...
- Contrast medium (discography or other diagnostic injection)
- NSAIDs
See the full eligibility criteria
Who can join
- Male and female people, between 18 and 75 years of age.
- Have documented the diagnosis of facet joint osteoarthritis from L1 to S1 in the opinion of the investigator.
- Have a documented diagnosis of symptomatic facet joint syndrome is defined as the following (subject must meet all the listed conditions):
- Chronic low back pain for at least 6 months.
- Have failed 3 months of conservative back pain care. (Conservative treatment regimens may include any or all of the following: initial rest, medications [e.g., anti-inflammatory, analgesics, narcotics/opioids, muscle...
- Have undergone supervised physical therapy, such as daily walking routines, therapeutic exercises, and back education programs specifically for the treatment of low back pain.
- Change from normal spine morphology at the symptomatic level as defined by Radiographic evaluation for Lumbar facet joint osteoarthritis.
- The baseline pain score of at least 4 on a pain scale of 0-10, over 24 hours
- people demonstrate \>80% relief of their pain after diagnostic injection.
- Signed informed consent indicating the subject is willing to undergo treatment and willing to be available for each examination scheduled over the study duration
What rules you out
- Female people who are pregnant or nursing, or women planning to become pregnant within 12 months following treatment.
- Females of childbearing age who have not used or do not plan to use acceptable birth control measures, for the duration of the study. Oral, injected or implanted hormonal contraceptive, barrier methods (condom or...
- Extreme obesity, as defined by NIH Clinical Guidelines Body Mass Index (BMI \> 40)
- Any lumbar intradiscal injection, including steroids, at the symptomatic or adjacent discs less than 3 months prior to treatment injection, except for the following injections performed at least 2 weeks prior to study...
- Contrast medium (discography or other diagnostic injection)
- NSAIDs
- Nerve-blocking anesthetics (e.g., lidocaine, bupivacaine)
- Antibiotics
- Saline
- Epidural steroid injections, prior lumbar facet joint injection, medial branch block or radiofrequency ablation of facet joint nerves within 8 weeks prior to treatment injection.
- Have received chronic (more than 7 consecutive days) treatment with systemic corticosteroids at a dose equivalent to prednisone ≥ 10 mg/day within 14 days prior to an injection procedure.
- Active malignancy or tumor as a source of symptoms or history of malignancy within the 2 years prior to enrollment on the study, except history of basal cell carcinoma of the skin, squamous cell carcinoma of the skin...
- Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
- Have been a recipient of prior allogeneic stem cell/progenitor cell therapy for any indication or autologous stem cell/progenitor cell therapy or other biological intervention to repair the target intervertebral disc or...
- An average baseline morphine equivalent dose (MED) of \>40mg/day collected during the screening visit.
- Are at a higher risk, in the opinion of the investigator, for bleeding (e.g., bleeding disorder, or taking anticoagulants, except low dose aspirin) or infection (e.g., taking immunosuppressants, have a severe infection...
- Current infection or prior history of spinal infection at the symptomatic level (e.g., discitis, septic arthritis, epidural abscess) or an active systemic infection.
- Severe and/or chronic pain conditions that may potentially confound facet joint symptom assessment, in the opinion of the investigator.
- Cauda equina syndrome.
- Receiving workman's compensation unless litigation is complete.
- Subject is part of a vulnerable population who, in the judgment of the investigator, is unable to give Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may...
- people with documented history of alcohol or drug abuse within the last year.
- Subject is in the opinion of the Investigator or designee, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason. This includes completion of patient reported outcome...
- Body habitus precluding adequate fluoroscopic visualization for the procedure or the procedure is physically impossible due to inability to inject the facet joint.
- Failed any component of the lumbar neurological exam at baseline (i.e., motor, sensory, or a reflex portion of the exam).
- The subject is receiving immunosuppressant therapy or has a known immunologic or severe autoimmune disease that requires chronic immunosuppressive or immunomodulatory therapy (e.g., human immunodeficiency virus...
- Clinically significant, in the opinion of the investigator, nerve pain (e.g., chronic radiculopathy) or clinically significant sacroiliac joint pain based on targeted, pre-specified physical examination, and, if deemed...
- Symptomatic lumbar intervertebral foraminal stenosis at the symptomatic level resulting in clinically significant spinal nerve root compression, in the opinion of the investigator.
- Symptomatic central vertebral canal, lateral recess stenosis or foraminal stenosis, in the opinion of the investigator.
- Severe instability where, in the opinion of the investigator, surgical interventions to stabilize the segment would be required.
- An acute fracture of the spine. Clinically compromised, in the opinion of the investigator, vertebral bodies at the symptomatic level due to current or past trauma, e.g., sustained a pathological fracture or multiple...
- History of Chronic tobacco and nicotine usage.
- Insufficient amount of subcutaneous tissue to allow recovery of at least 100 mL of adipose tissue.
- people who have document allergy to radiographic agents or sodium citrate or any "caine" type of local anesthetic.
- people with radicular leg pain as determined by investigator
The study team makes the final eligibility decision.
Where it's taking place
- Deerfield Beach, Florida, United States
- Sioux Falls, South Dakota, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Deerfield Beach, Florida, United States; Sioux Falls, South Dakota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.