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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

Sponsor: Regenexx, LLC · Participants: 42 · Started: May 6, 2022

Contact the study team

Official record on ClinicalTrials.gov — NCT05287867

Locations in the U.S.

ColoradoCenteno-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.