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Trial for Treating Painful Degenerative Disc Disease

Regenexx, LLC · NCT05287867

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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
Trial for Treating Painful Degenerative Disc Disease (NCT05287867) | Bored Studies