Trial for Treating Painful Degenerative Disc Disease

Launched by REGENEXX, LLC · Mar 15, 2022

Keywords

ClinConnect Summary

This clinical trial is studying new treatments for degenerative disc disease, which causes chronic back and leg pain. The researchers want to compare two types of treatments that use platelets, which are tiny cells in your blood that help with healing, to a placebo (a sham procedure that doesn’t have any active treatment). Participants will receive their assigned treatment four weeks apart to see which option is more effective in relieving pain and improving function.

To join the trial, participants must be between 25 and 65 years old and have been dealing with chronic pain that hasn't improved with standard treatments like physical therapy or pain medications for at least six months. They should have a specific type of degenerative disc disease that affects up to three levels of the spine and requires surgical options like fusion or decompression. Participants will need to be able to get to follow-up appointments after treatment. This trial is currently recruiting participants, and it’s important to note that those who smoke, have certain medical conditions, or have recently had specific treatments may not be eligible.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Voluntary signature of the IRB approved Informed Consent,
• • Skeletally mature Male or Female ages 25 to 65
• • Maximum of 3 levels degenerative disc disease without significant spondylolisthesis in the area c/w the pain (grade 1 with less than or equal to 10% vertebral body)
• • Chronic back and/or leg pain having failed conservative treatment (e.g. NSAIDs, physician initiated physical therapy) for at least 6 months
• • MRI and physical examination consistent with painful Degenerative Disc Disease
• • Failure of epidural steroid injection, facet injection, medial branch block, radiofrequency ablation or physical therapy
• • Instability as seen on MRI, flexion-extension x-ray, or physical deformity as seen on MRI c/w degenerative instability (facet hypertrophy, loss of disc height, spondylolisthesis, laterolisthesis, osteophytes)
• • A lumbar surgery candidate (will need to specify which surgery, ie. fusion, decompression, etc)
• • Is independent, ambulatory, and can comply with all post-operative evaluations and visits
• Exclusion criteria:
• • Evidence of more than moderate central canal or foraminal stenosis
• • Smoker or cessation for less than 6 weeks
• • Untreated underlying psychological conditions (e.g. depression, chronic pain syndrome, etc.) as a contributor to chronic pain
• • Prior epidural steroid injection within the past 8 weeks
• • Degenerative scoliosis if cob angle over 10 degrees
• • Undergone previous Regenexx lumbar procedure
• • Standing intolerance (patient cannot stand longer than 30 minutes)
• • Inflammatory or auto-immune based pathology (e.g., rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis, polymyalgia, polymyositis, gout pseudogout)
• • Severe neurogenic inflammation of the cutaneous nerves
• • Condition represents a worker's compensation case
• • Currently involved in a health-related litigation procedure
• • Is pregnant
• • Bleeding disorders
• • Currently taking anticoagulant or immunosuppressive medication
• • Allergy or intolerance to study medication
• • Use of chronic opioid
• • Documented history of drug abuse within six months of treatment
• • Central sensitization
• • Hypermobile or EDS
• • 19) Any other condition, that in the opinion of the investigator, that would preclude the patient from enrollment