Phase
Condition
N/ATreatment
Sham procedure
Platelet-rich plasma (PRP), Platelet lysate (PL), and Platelet Poor Plasma (PPP)
Clinical Study ID
Ages 25-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 spondylolisthesisin 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 seenon 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 andvisits
Exclusion
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 painsyndrome, 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, systemiclupus erythematosus, psoriatic arthritis, polymyalgia, polymyositis, goutpseudogout)
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
- Any other condition, that in the opinion of the investigator, that wouldpreclude the patient from enrollment
Study Design
Study Description
Connect with a study center
Centeno-Schultz Clinic
Broomfield, Colorado 80021
United StatesActive - Recruiting
Centeno-Schultz Clinic
Lone Tree, Colorado 80124
United StatesActive - Recruiting
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