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New treatment option for Degenerative Disc Disease
Official title Trial for Treating Painful Degenerative Disc Disease
ClinicalTrials.gov ID: NCT05287867
What this study is testing
What is Platelet-rich plasma (PRP), Platelet lysate (PL), and Platelet Poor Plasma (PPP)?
Platelet-rich plasma (PRP), Platelet lysate (PL), and Platelet Poor Plasma (PPP) is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for degenerative disc disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 25 to 65
You may be able to join if
- 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%...
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Broomfield, Colorado, United States
- Lone Tree, Colorado, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 25 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Broomfield, Colorado, United States; Lone Tree, Colorado, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.