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Study for Painful Degenerative Disc Disease Using Platelet-Based Treatments

This study is looking at new ways to treat painful degenerative disc disease, a condition where the discs between your spinal bones wear down. Researchers are comparing two treatments made from your own blood: Platelet-rich plasma (PRP), Platelet lysate (PL), and Platelet Poor Plasma (PPP). These are injected into your lower back. You might be eligible if you are between 25 and 65 years old, have chronic back or leg pain from degenerative disc disease (up to 3 levels), and other treatments haven't worked. The main goal is to see if these treatments reduce your pain (Numeric Pain Scale) and improve your overall function (Modified Single Assessment Numerical Evaluation scores) three months after the second treatment.

Study design
This is a single-blind, randomized, placebo-controlled study with 42 participants. Two out of three participants will receive the platelet-based treatment, while one will receive a sham procedure.
What's involved
You would have two treatment sessions four weeks apart. There will be follow-up visits at 3 and 12 months after your last injection, with questionnaires completed at 1, 3, 6, and 12 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 12 months after their last treatment to assess long-term effects.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05287867

Trial for Treating Painful Degenerative Disc Disease

Recruiting
NAAges 25–65InterventionalTreatment
Regenexx, LLC
~42 participants
Updated 2025-04-06 on ClinicalTrials.gov
What's tested:Platelet-rich plasma (PRP), Platelet lysate (PL), and Platelet Poor Plasma (PPP)Sham procedure

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Numeric Pain Scale (NPS)
Measured over 3-months after 2nd treatment
+1 more outcome measured

Conditions

Degenerative Disc Disease

Explore related trials

Intervertebral Disc Degenerative Disorder

NCT05287867

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Centeno-Schultz Clinic

    Broomfield, Coloradostudy coordinator listed

    Recruiting

  • Centeno-Schultz Clinic

    Lone Tree, Coloradostudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Christopher Centeno, MD · PRINCIPAL_INVESTIGATOR · Centeno-Schultz Clinic

Who to contact

Ehren Dodson, PhD
[email protected]
7202877199
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Numeric Pain Scale (NPS)3-months after 2nd treatment

    Difference in Numeric Pain Scale group differences (scale 0-10, where 0=no pain and 10=worst possible pain

  • Modified Single Assessment Numerical Evaluation (SANE) scores3-months after 2nd treatment

    Difference in modified Single Assessment Numerical Evaluation score group differences; scores range from 0-100 where 0=no improvement and 100=100% improved