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Clinical Studies

Regenexx regularly conducts studies relating to regenerative medicine involving stem cells, blood platelets, and other orthobiologics.

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.

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 combined with an extracellular matrix (ACell MicroMatrix) 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 studycandidate@regenexx.com.

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 studycandidate@regenexx.com.

Stem Cell Therapy ehren acl thumb - Clinical Studies

ACL Study Criteria Patient Requirements

  • The patient must be willing to come to the Broomfield clinic for first an initial evaluation to make a final determination of study eligibility (includes diagnostic ultrasound)
  • There is no guarantee they will be eligible
  • The cost of this evaluation will be billed to the patient and/or their insurance
  • If eligible, the patient must be willing to return for treatment at the Broomfield clinic and for all post-injection treatments (6 weeks, 3 months, 6 months, 12 months, 24 months)
  • Costs of any travel will be the responsibility of the patient
  • The patient will be randomized to receive either Regenexx-SD treatment or be instructed in a home exercise therapy program
  • Patients in the exercise therapy group will have the opportunity to receive a Regenexx SD treatment after the three month visit if they do not respond to the exercise therapy
  • The Regenexx SD treatment will be provided at no cost to the patient
  • The patient must have a knee MRI current within the last year at their own cost for study screening purposes.
  • The subject must meet all inclusion criteria and not meet any exclusion criteria (complete list below). Key criteria include:
    • Age 18-65
    • can comply with all post-operative evaluations and visits
    • No previous surgery to the affected ACL
    • No PCL or LCL tears of same knee
    • No painful meniscus or cartilage injury at same time as the ACL tear
    • No current or past malignancy (cancer)

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 to 65
  3. Pain, swelling, or functional disability in the affected knee with activity, having failed conservative treatment (e.g. NSAIDs, physician initiated physical therapy) for at least 3 months or unable to return to normal day to day activities by 6 weeks
  4. Physical examination consistent with lax ACL ligament (Anterior Drawer Test)
  5. Abnormal Telos Arthrometer measurement
  6. Positive diagnostic MR imaging of the affected knee with at least 1/3 of the ACL ligament at any area along its length having high signal on MRI PDFS/Fat Sat images.
  7. Full range of motion of the affected knee (other than restriction clearly due to effusion)
  8. Normal range of motion of the non-treated knee
  9. 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. A massive ACL tear or one that includes more than 2/3’rds of the ligament that’s retracted.
  2. Previous surgery to the affected ACL (i.e. previous ACL replacement with an autograft or allograft)
  3. Prior ACL prolotherapy, PRP, corticosteroid injection or other injection therapy within the past three months,
  4. Concomitant meniscus tear or cartilage injury that occurred at the same time as the as the ACL tear and which is considered a pain generator by the treating physician at the time intake into the study (i.e. a meniscus tear or cartilage lesion associated with an active BML).
  5. Concomitant PCL or LCL tears
  6. 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)
  7. Quinolone or Statin induced myopathy/ tendinopathy
  8. Kellgren-Lawrence grade 2 or greater knee osteoarthritis
  9. Significant knee extension lag compared to the opposite knee
  10. Symptomatic lumbar spine pathology (e.g. radicular pain)
  11. Severe neurogenic inflammation of the cutaneous nerves about the knee or thigh
  12. Contraindications for MRI
  13. Tested positive or has been treated for a malignancy in the past or is suspected of having a malignancy or is currently undergoing radiation or chemotherapy treatment for a malignancy anywhere in the body, whether adjacent to or distant from the proposed injection site
  14. Condition represents a worker’s compensation case
  15. Currently involved in a health-related litigation procedure
  16. Is pregnant
  17. Bleeding disorders
  18. Currently taking anticoagulant or immunosuppressive medication
  19. Allergy or intolerance to study medication
  20. Use of chronic opioid,
  21. Documented history of drug abuse within six months of treatment
  22. 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 of visits, please contact us at 720-943-6990. or via email at studycandidate@regenexx.com.

Stem Cell Therapy ehren rotator cuff thumb - Clinical Studies

Shoulder Rotator Cuff Study Patient Requirements

  • The patient must be willing to come to the Broomfield clinic for first an initial evaluation to make a final determination of study eligibility (includes diagnostic ultrasound)
  • There is no guarantee they will be eligible
  • The cost of this evaluation will be billed to the patient and/or their insurance
  • If eligible, the patient must be willing to return for treatment at the Broomfield clinic and for all post-injection treatments (6 weeks, 3 months, 6 months, 12 months, 24 months)
  • Costs of any travel will be the responsibility of the patient
  • The patient will be randomized to receive either Regenexx-SD treatment or be instructed in a home exercise therapy program
  • Patients in the exercise therapy group will have the opportunity to receive a Regenexx SD treatment after the three month visit if they do not respond to the exercise therapy
  • The Regenexx SD treatment will be provided at no cost to the patient
  • The patient must have a shoulder MRI current within the last year at their own cost for study screening purposes.
  • The subject must meet all inclusion criteria and not meet any exclusion criteria (complete list below). Key criteria include:
    • Age 18-65
    • Can comply with all post-operative evaluations and visits
    • No previous surgery to the affected shoulder
    • No current or past malignancy (cancer)

Inclusion Criteria

Candidates must meet ALL of the following:

  • Voluntary signature of the IRB approved Informed Consent,
  • Skeletally mature Male or Female ages 18 to 65
  • Unremitting pain in the affected shoulder having failed conservative treatment (e.g. NSAIDs, physician initiated physical therapy or a corticosteroid injection) for at least 3 months
  • Significant functional disability related to pain, lack of strength, or other shoulder symptoms
  • Physical examination consistent with Rotator Cuff tea
  • Positive diagnostic imaging, which may include arthrogram, ultrasound and/or MR, on the affected shoulder indicating a non-retracted supraspinatus tendon tear comprising at least one half the tendon thickness in the anterior-posterior and/or superior-inferior planes
  • Reasonable movement of the non-treated arm, defined as a shoulder elevation of equal or more than 90°, and able to perform (post-injection) exercises
  • 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:

  • A massive rotator cuff tear as demonstrated by Grade 3 or less muscle strength on testing internal and external rotation of the affected shoulder
  • Previous surgery to the affected shoulder
  • Prior rotator cuff prolotherapy, PRP or other RC injection-based therapies within the past three months,
  • Concomitant tears of concomitant tears of the bicep tendons or biceps tendons
  • Grade 2 or greater SLAP tear
  • Type 3 acromion
  • Significant bone spur in subacromial space
  • Inflammatory or auto-immune based joint diseases or other upper extremity pathology (e.g., rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis, polymyalgia, polymyositis, gout pseudogout)
  • Quinolone or Statin induced myopathy/ tendinopathy
  • Kellgren-Lawrence grade 2 or greater glenohumeral osteoarthritis
  • Adhesive capsulitis (mild or severe)
  • Symptomatic cervical spine pathology (e.g. radicular cervical pain)
  • Severe neurogenic inflammation of the cutaneous nerves about the shoulder
  • Shoulder instability requiring surgical stabilization
  • Contraindications for MRI
  • Tested positive or has been treated for a malignancy in the past or is suspected of having a malignancy or is currently undergoing radiation or chemotherapy treatment for a malignancy anywhere in the body, whether adjacent to or distant from the proposed injection site
  • 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
  • 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 of visits, please contact us at 720-943-6990. or via email at studycandidate@regenexx.com.

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 720-943-6990. or via email at studycandidate@regenexx.com.

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