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Clinical Studies

Regenexx regularly conducts studies relating to regenerative medicine involving bone marrow concentrate & blood platelets.

Current Clinical Studies

Regenexx conducts clinical studies to refine our methodology and to explore the application of new regenerative technologies.

If you are interested in being a participant in a clinical study, you may be eligible. Participants must meet all of the inclusion / exclusion criteria for a given study and be able to travel to the area where the study is being conducted for all required visits.

See below for clinical studies currently accepting applications.

Stem Cell Support Formula Study for Patients with Knee Osteoarthritis

Stem Cell Support Formula Study for Patients with Knee Osteoarthritis

Our Research Team is conducting a study to understand the effects of the Regenexx Stem Cell Support Formula on joint health. Participants in the study will be randomly assigned to one of 2 groups, either to receive the real supplement formula or a placebo supplement. Patients will take 1 ounce (1 capful) of the liquid supplement provided for 2 months. Participants will keep a daily diary to document doses and pain medications taken. After taking the supplement for 1-month, participants will complete online surveys and have a check-in with someone from our research team. At 2-months, participants will check-in with one of our research staff to complete another set of questionnaires and final study activities. They will also be told at that time whether they had been assigned to the real or placebo supplement. If in the placebo group, you will receive 2 real bottles of supplement at no cost.

 

Candidates must meet ALL of the following:

  • Voluntary signature of the IRB approved Informed Consent
  • Unilateral or bilateral osteoarthritic male or female ages 18-80
  • Pain, swelling, and/or functional disability in the affected knee consistent with osteoarthritis in the knee joint
  • Physical examination consistent with osteoarthritis in knee joint
  • Kellgren-Lawrence grade 2 or 3 knee osteoarthritis and/or diagnostic MRI imaging of the affected knee showing osteoarthritis (i.e. chondral loss, fissuring, defect, bone marrow lesion, meniscus tear, synovial thickening, etc.)
  • Minimum of 3/10 on NPS approximately 3 days per week
  • Is independent, ambulatory, and can comply with all evaluations and visits

 

Candidates will be excluded if they meet ANY of the following:

  • Previously taken the Regenexx Stem Cell Support Formula
  • Receiving active knee treatment or any knee injections of any type within 3 months prior to the study (steroids, biologics, etc.)
  • Knee surgery within 6 months prior to the study
  • Currently taking or history of taking products that contain curcuminoid extract within the last 2 weeks
  • Dependent on NSAIDs or acetaminophen for exercise or daily activities
  • Currently taking or previously taken fish oil in the last 2 weeks
  • Currently taking or previously taking MSM or glucosamine in the last 2 weeks
  • Diabetic
  • Inflammatory or auto-immune based joint diseases or other lower extremity pathology (e.g., rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis, polymyalgia, polymyositis, gout pseudogout)
  • Quinolone or statin-induced myopathy/tendinopathy
  • Severe neurogenic inflammation of the cutaneous nerves about the knee or thigh
  • Contraindications for MRI
  • Condition represents a worker’s compensation case
  • Currently involved in a health-related litigation procedure
  • Is pregnant or breastfeeding
  • Currently taking immunosuppressive medication
  • Allergy or intolerance to study medication (e.g. shellfish)
  • Use of chronic opioid
  • Documented history of drug abuse within six months of treatment
  • Blood clotting disorder, taking an anticoagulant, or history of cardiovascular disease
  • History of prostate cancer
  • Has asthma
  • Any other condition, that in the opinion of the investigator, that would preclude the patient from enrollment including current supplement use

If you are interested in seeing if you are a candidate for participating in this study, please email Ehren Dodson, PhD, Clinical Research Director, at [email protected] or call 720-287-7199.

Regenexx Multifidus/Low Back Pain Study

Multifidus Study Requirements

  • The patient must be willing to come to the Broomfield or Lone Tree clinic for initial evaluation to make a final determination of study eligibility
  • There is no guarantee they will be eligible
  • The patient must have a current MRI within last 6 months for screening purposes
  • If eligible, the patient must be willing to return to either clinic for all treatments (series of injections for 6 weeks) and follow-up visits (3 months, 6 months and 1 year). Physical therapy visits only occur at the Broomfield clinic on weeks 1 and 3 in conjunction with treatment
  • Costs of any travel will be the responsibility of the patient
  • The patient will be randomized to one of 3 treatment conditions:
      • Group 1: Platelet poor plasma injected to the multifidus muscle (6 weekly treatments)
      • Group 2: Platelet rich plasma injected into the multifidus muscle (6 weekly treatments)
      • Group 3: Platelet rich plasma injected into the multifidus and facet joints, platelet lysate injected into the nerves (epidural) (series of 3 every 2 weeks)
  • Treatments are at no cost to patient
  • Patients will know the condition to which they have been randomized
  • Patients must be able to undergo blood draws for each treatment
  • The patient must meet all inclusion criteria and none of the exclusion criteria for the study to be eligible. Key criteria include:
    • Axial low back pain for at least 3 months
    • Age 18-75
    • Recent MRI consistent with Kader grade 2 or 3 multifidus atrophy at 1 or 2 levels
    • No more than 2 levels of multifidus atrophy Kader grade 2 or 3
    • No symptomatic spinal stenosis
    • No radicular symptoms (lower extremity numbing or tingling)
    • No previous spine surgery
    • No corticosteroid injection to spine within the last 3 months

Inclusion Criteria

Candidates must meet ALL of the following:

  1. Voluntary signature of the IRB approved Informed Consent
  2. Skeletally mature male or female ages 18-75
  3. Axial low back pain for a minimum of 3 months
  4. Recent MRI (within last 6 months) consistent Kader grade 2 or 3 multifidus atrophy at 1 or 2 levels
  5. Is independent, ambulatory, and can comply with all post-operative evaluations and visits

Exclusion Criteria

Candidates will be excluded if they meet ANY of the following:

  1. Mild multifidus atrophy Kader grade 1 only
  2. Multifidus atrophy at more than 2 levels
  3. Symptomatic spinal stenosis (e.g. pseudoclaudication with moderate or severe MRI findings of stenosis)
  4. Radicular symptoms (e.g. lower extremity radiating numbness, tingling, paresthesia, etc.)
  5. Fracture previous spine surgery, neuromuscular disease of the trunk, malignancy, infection, or pregnancy
  6. Radiofrequency Ablation (RFA) within the previous 12 months
  7. Corticosteroid injection (epidural or facet) within the past 3 months
  8. Contraindications for MRI
  9. Condition represents a worker’s compensation case
  10. Currently involved in a health-related litigation procedure
  11. Bleeding disorders
  12. Allergy or intolerance to study medication
  13. Use of chronic opioid
  14. Documented history of drug abuse within 6 months of treatment
  15. Any other condition, that in the opinion of the investigator, that would preclude the patient from enrollment

If you meet all of the criteria for a study and are able to travel to the research study location for all of the required follow-up visits, please contact us at 720-669-8330 or via email at [email protected].

Alar Ligament/CCJ Instability Study (PICL Procedure)

Alar Study Requirements

  • The patient must be willing to come to the Broomfield clinic for evaluation to make a determination of study eligibility
  • There is no guarantee they will be eligible
  • The patient must have a current digital motion x-ray (DMX) for screening purposes
  • The patient must have received and not responded long-term to upper cervical facets and ligament injections
  • If eligible, the patient must be willing to return to clinic for treatment and follow-up visits (6 and 12 months), as well as complete 6-month DMX in Boulder, CO
  • Enrolled patients are randomized and blinded to study condition of either the treatment condition or sham condition. Treatment involves a bone marrow aspiration and injection of the bone marrow concentrate (Regenexx-SD) into the alar, accessory and transverse ligaments via injection through the back of the throat under anesthesia. The sham procedure involves a “mock injection” which involves a needle poke to the back of the throat on each side while under anesthesia. Patients are unblinded to study condition at 6-month visit. Patients in the sham condition are given the opportunity to crossover into the treatment condition after 6-months upon learning they were in the sham condition.
  • Patients complete online surveys at 1-month, 3-months, 6-months and 12 months post-procedure
  • Treatments and study-related follow-up visits and 6-month DMX are provided at no cost to patient
  • Costs of any travel will be the responsibility of the patient

The patient must meet all inclusion criteria and none of the exclusion criteria for the study to be eligible. Final determination of study eligibility made by principle investigator

Inclusion criteria

Candidates must meet ALL of the following:

  1. Voluntary signature of the IRB approved Informed Consent
  2. Skeletally mature male or female ages 18-65
  3. Disabling symptoms of headache, dizziness, neck pain, or other neuro-musculoskeletal symptoms, that based on physical exam or diagnostic blocks is attributable to the upper cervical spine, for >12 months
  4. Symptoms exacerbated by activity and relieved by rest
  5. Failed all conservative care
  6. Hasn’t responded long-term to:
    1. C0-C3 facet injections
    2. Upper cervical prolotherapy or PRP into the posterior stabilizing ligaments (nuchal, supraspinous, interspinous ligaments)
  7. Considered a likely cervical fusion candidate
  8. Imaging
    1. Upper cervical MRI showing decreased signal in alar, transverse, PAOM, AAOM, or Tectorial membrane
    2. DMX showing 2 mm or greater lateral overhang of C1 on C2 in lateral bending open mouth view or a V shaped ADI in flexion of increased ADI in flexion
    3. Upper cervical rotatory CT that shows excessive C0-C1 rotation
  9. Exam is c/w upper cervical injury (i.e. tenderness along upper cervical facet joints and/or musculature/skull base, good anesthetic block response (>50% pain relief) to C0-C3 intra-articular facet injections, proprioceptive difficulties)
  10. Is independent, ambulatory, and can comply with all post-operative evaluations and visits
  11. Patient states strong desire to avoid surgery

Exclusion Criteria

  1. Candidates will be excluded if they meet ANY of the following:
  2. Unable to tolerate injections due to central sensitization (i.e. significant intolerance to manual therapy such as massage, activity such as physical therapy, or an exaggerated pain response to prior injection therapy)
  3. Previous neck surgery that has caused chronic neck pain or radiculopathy
  4. Prior epidural or other milligram dose steroid injection in any area or other neck injection therapy within the past 6 months
  5. Physical infirmity that is incompatible with the procedure and/or anesthesia required for same
  6. Unable to tolerate the injection position
  7. Abnormal anatomy seen on MRI imaging that would make the procedure higher risk (e.g. congenital atlanto-axial fusion, atlas assimilation, upper cervical fracture or surgical fusion)
  8. Inflammatory or auto-immune based pathology (e.g. rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis, polymyalgia, polymyositis, gout, pseudo gout)
  9. Quinolone or Statin induced myopathy/tendinopathy
  10. Condition represents a worker’s compensation case
  11. Currently involved in a health-related litigation procedure
  12. Is pregnant
  13. Bleeding disorders
  14. Currently taking anticoagulant or immunosuppressive medication
  15. Allergy or intolerance to study medication
  16. Use of and significant physical dependence on a chronic opioid (>20 mg oxycodone equivalent per day)
  17. Documented history of drug abuse within 6 months of treatment
  18. Any other condition, that in the opinion of the investigator, that would preclude the patient from enrollment

If you meet all of the criteria and are able to travel to the research study location for all of the required follow-up visits, please contact us at 720-669-8330 or via email at [email protected].

If you meet all of the criteria for a study and are able to travel to the research study location for all of the required follow-up of visits, please contact us at 720-287-7199. or via email at [email protected].