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Clinical Studies

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

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.

Current 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 MCL, 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, MCL, 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 404.800.0302. or via email at [email protected].

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 multiple rotator cuff 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 404.800.0302. 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 404.800.0302. or via email at [email protected].

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