Trial for Treating Painful Degenerative Disc Disease

Last updated: April 2, 2025
Sponsor: Regenexx, LLC
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Sham procedure

Platelet-rich plasma (PRP), Platelet lysate (PL), and Platelet Poor Plasma (PPP)

Clinical Study ID

NCT05287867
RGX2021-01
  • Ages 25-65
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 spondylolisthesisin 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 seenon 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 andvisits

Exclusion

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 painsyndrome, 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, systemiclupus erythematosus, psoriatic arthritis, polymyalgia, polymyositis, goutpseudogout)

  • 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

  1. Any other condition, that in the opinion of the investigator, that wouldpreclude the patient from enrollment

Study Design

Total Participants: 42
Treatment Group(s): 2
Primary Treatment: Sham procedure
Phase:
Study Start date:
May 06, 2022
Estimated Completion Date:
December 31, 2026

Study Description

This is a single-blind, randomized, placebo-controlled study using platelet-based treatment to the functional spinal unit .in a series of 2 treatments 4 weeks apart to treat painful lumbar degenerative disc disease. Randomization is 2:1, with 28 in the treatment group and 14 in the sham control group.

A pretreatment visit will occur at or before the time of enrollment; follow-up visits will occur at the clinical site at 3- and 12 months post injection. Target enrollment is 42 subjects. Patients in the control group can crossover to the treatment group after 3-month follow-up. Crossover patients then follow the treatment group follow-up timeline based on their second real treatment. Subjects will complete the study following the 1-year follow-up visit.

The primary objective of this study is to observe the improvement in subject-reported clinical outcomes from baseline to 3 months after 2nd treatment and between groups at 3 months, with continued evaluation of efficacy and durability up to 12 months. Questionnaires are completed at 1, 3, 6, and 12 months.

Connect with a study center

  • Centeno-Schultz Clinic

    Broomfield, Colorado 80021
    United States

    Active - Recruiting

  • Centeno-Schultz Clinic

    Lone Tree, Colorado 80124
    United States

    Active - Recruiting

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