Home › Intervertebral Disc Degeneration › NCT05287867
Trial for Treating Painful Degenerative Disc Disease
Recruiting
A Trial of Platelet Injections for Treatment of Painful Degenerative Disc Disease
Who can join
Ages 25 to 65 · All sexes
Full 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
About the study
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.
What is being tested
- Platelet-rich plasma (PRP), Platelet lysate (PL), and Platelet Poor Plasma (PPP) (biological)
- Sham procedure (other)
Sponsor: Regenexx, LLC · Participants: 42 · Started: May 6, 2022
Contact the study team
- Ehren Dodson, PhD · Phone: 7202877199
Official record on ClinicalTrials.gov — NCT05287867
Locations in the U.S.
| Colorado | Centeno-Schultz Clinic, Broomfield Centeno-Schultz Clinic, Lone Tree |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.