Treating Painful Degenerative Disc Disease with Platelet-Based Treatments
A Trial of Platelet Injections for Treatment of Painful Degenerative Disc Disease
This study is testing whether two new platelet-based treatments can help people with painful degenerative disc disease feel better compared to a placebo.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 25 Years to 65 Years |
| Sex | All |
| Sponsor | Regenexx, LLC Industry-sponsored |
| Locations | 2 sites (Broomfield, Colorado and 1 other locations) |
| Trial ID | NCT05287867 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of two platelet-based treatments for painful degenerative disc disease compared to sham procedures. It is a single-blind, randomized, placebo-controlled study where participants receive treatments spaced four weeks apart. The study aims to assess improvements in clinical outcomes reported by subjects at various follow-up intervals, including 3 and 12 months post-treatment. A total of 42 subjects will be enrolled, with a 2:1 randomization between the treatment and control groups.
Who should consider this trial
Good fit: Ideal candidates are skeletally mature adults aged 25 to 65 with chronic back or leg pain due to degenerative disc disease who have not responded to conservative treatments.
Not a fit: Patients with significant spondylolisthesis or those who have not failed conservative treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new, effective treatment option for patients suffering from painful degenerative disc disease.
How similar studies have performed: Other studies using platelet-based therapies for musculoskeletal conditions have shown promising results, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Broomfield, Colorado and 1 other locations
- Centeno-Schultz Clinic — Broomfield, Colorado, United States (Recruiting)
- Centeno-Schultz Clinic — Lone Tree, Colorado, United States (Recruiting)
Study contacts
- Principal investigator: Christopher Centeno, MD — Centeno-Schultz Clinic
- Study coordinator: Ehren Dodson, PhD
- Email: edodson@regenexx.com
- Phone: 7202877199
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.