Regenexx ACL Stem Cell Procedure Study

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 888-525-3005 or via email at [email protected].