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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.

Regenexx Lumbar Degenerative Disc Disease (DDD) Study

Study for Patients with Lumbar Degenerative Disc Disease

Patients must be able to visit the Centeno-Schultz Clinic in Broomfield, CO for evaluation, two treatment procedures spaced 1-month apart, in addition to two follow-up visits after the 2nd procedure, at a minimum.

Our Research Team is conducting a study investigating how a series of two platelet-based treatments (made from a patient’s own blood) affect symptoms of lumbar degenerative disc disease. Patients in the study will be randomly assigned to receive either two real treatments or two sham control procedures (to mimic spine injection treatment, although nothing is injected), in a 2:1 allocation. Hence 28 patients will be assigned to the treatment group and 14 to the sham control group. Patients assigned to the control group can cross-over to the treatment group at the 3-month follow-up visit, when all patients are notified as to which study group they had been assigned. Patient reported outcomes surveys will be completed before treatment, as well as at 1-, 3-, 6-, and 12-months.

All patients will need a lumbar MRI or lumbar flexion-extension x-ray to determine if they are a candidate.

Candidates must meet ALL of the following:

  • Skeletally mature male or female ages 25-65
  • Maximum of 3 levels of 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, i.e., fusion, decompression, etc.)
  • Is independent, ambulatory, and can comply with all post-operative evaluations and visits

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

  • Evidence of more than moderate central canal or foraminal
  • 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 last 8 weeks
  • Degenerative scoliosis if cob angle over 10 degrees
  • Undergone previous Regenexx lumbar procedure
  • Standing intolerance (patient cannot stand longer than 30 mins)
  • Inflammatory or auto-immune based joint diseases or other lower extremity pathology
  • 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

Any other condition, that in the opinion of the investigator, that would preclude the patient from enrollment

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.

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.

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. Must have a specific inciting injury event that occurred less than 10 years ago where the patient experienced trauma that caused the problem-meaning from that day on, they had the symptoms for which they are now seeking treatment
  4. Upper cervical symptoms predominate: Patient must have a headache since the event and must have one of the following: dizziness, vertigo, imbalance, or visual disturbances
  5. Patient must be able to care for themselves without assistance
  6. NDI percentage score (raw NDI score times 2) at least 30 (moderate disability)
  7. Imaging: Must have DMX overhang of at least 3mm or grabb-oakes of >9mm on cervical flexion MRI-change in signal on static imaging does not qualify the patient
  8. Hasn’t responded long-term to conservative care
  9. Upper cervical fusion candidate
  10. Exam is c/w upper cervical injury (i.e. tenderness along upper cervical facet joints and/or musculature/skull base, proprioceptive difficulties)
  11. Is independent, ambulatory, and can comply with all post-operative evaluations and visits
  12. Patient states strong desire to avoid surgery

Exclusion Criteria

  1. Known or diagnosed EDS based on Beighton criteria: https://www.physio-pedia.com/Beighton_score
  2. Lower or mid-cervical symptomatic disease (tenderness in mid to lower cervical facets, radiculopathy, radiating symptoms into shoulder blade, epicondylitis, numbness and tingling in hands)
  3. Prior spinal fusion or surgery at any segment in cervical, thoracic, or lumbar spine
  4. NDI % score > than 56 (severe disability), unless at the discretion of the independent physician review
  5. Prior or current history of a metabolic disorder like diabetes, anorexia, other eating disorder, BMI>40
  6. 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)
  7. Prior epidural or other milligram dose steroid injection in any area within the past 6 months
  8. Prior prolotherapy or platelet-based injections to the cervical spine within the last 3 months
  9. Prior radiofrequency ablation to the cervical spine within the last 2 years
  10. Physical infirmity that is incompatible with the procedure and/or anesthesia required for same
  11. Unable to tolerate the injection position
  12. 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)
  13. Inflammatory or auto-immune based pathology (e.g. rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis, polymyalgia, polymyositis, gout, pseudo gout)
  14. Quinolone or Statin induced myopathy/tendinopathy
  15. Condition represents a worker’s compensation case
  16. Currently involved in a health-related litigation procedure
  17. Is pregnant
  18. Bleeding disorders
  19. Currently taking anticoagulant or immunosuppressive medication
  20. Allergy or intolerance to study medication
  21. Use of and significant physical dependence on a chronic opioid (>20 mg oxycodone equivalent per day)
  22. Documented history of drug abuse within 6 months of treatment
  23. 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].