Trial for Treating Painful Degenerative Disc Disease
Regenexx, LLC · NCT05287867
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 25–65 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Not applicable
- Target enrollment
- 42
- US sites recruiting
- 2
- Study start
- May 6, 2022
- Record last updated
- April 6, 2025
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
To evaluate and compare two platelet-based treatments of the functional spinal unit spaced 4 weeks apart to sham procedures for the treatment of degenerative disc disease.
Being studied: Platelet-rich plasma (PRP), Platelet lysate (PL), and Platelet Poor Plasma (PPP); Sham procedure
Conditions: Degenerative Disc Disease
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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
Recruiting US locations
Centeno-Schultz Clinic
Broomfield, CO 80021
Site contact: Eric Speer, MBA · espeer@centenoschultz.com
Centeno-Schultz Clinic
Lone Tree, CO 80124
Site contact: Eric Speer · espeer@centenschultz.com
Study contacts (from the official record)
- Ehren Dodson, PhD · 7202877199 · edodson@regenexx.com
- Neven Steinmetz, PhD · nsteinmetz@regenexx.com