Osteoarthritis, Knee
Conditions
Keywords
Osteoarthritis, Knee
Brief summary
The primary objective of this study is to determine the levels of proteins and/or cellular components of the synovial fluid that are indicative of microenvironment phenotypes of the osteoarthritic knee compared to unilateral unaffected joints pre-injection to 6 weeks post-Regenexx® SD treatment.
Detailed description
The primary objective of this study is to determine the levels of proteins and/or cellular components of the synovial fluid that are indicative of microenvironment phenotypes of the osteoarthritic knee compared to unilateral unaffected joints pre-injection to 6 weeks post-Regenexx SD treatment (day 0). Secondary objective is an evaluation of possible direct and/or indirect associations between the measured levels of proteins and/or cellular components of the synovial fluid in the osteoarthritic knee joint with the administration of the Regenexx SD treatment. The secondary objective will include MRI evidence of cartilage repair; incidence of post-operative complications, adverse events, re-injections, and surgical intervention; change in pain score and use of pain medications.
Interventions
PROCEDURERegenexx SD
stem cell treatment
Sponsors
Regenexx, LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
35 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Voluntary signature of the IRB approved Informed Consent 2. Unilateral osteoarthritic male or female ages 35-85 3. Pain, swelling, and/or functional disability in the affected knee consistent with osteoarthritis in one knee joint 4. Physical examination consistent with osteoarthritis in one knee joint 5. Restricted range of motion of the affected knee (\<135 degrees in flexion and/or \>0 degrees of extension) 6. Kellgren-Lawrence grade 2 or greater knee osteoarthritis with diagnostic MR imaging of the affected knee showing osteoarthritis 7. Limited knee effusion in osteoarthritic knee (i.e. not more than 20 ml of visible joint fluid on ultrasound examination of the knee.) 8. Normal range of motion of the unaffected knee 9. No sign of pain, swelling, and/or functional disability of the unaffected knee 10. No history of acute injury in the unaffected knee 11. Is independent, ambulatory, and can comply with all post-operative evaluations and visits
Exclusion criteria
1. Knee injections of any type within 6 months prior to the study. 2. 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) 3. Quinolone or Statin induced myopathy/tendinopathy 4. Symptomatic lumbar spine pathology (e.g. radicular pain) 5. Severe neurogenic inflammation of the cutaneous nerves about the knee or thigh (i.e. evidence of complex regional pain syndrome or central sensitization with allodynia present on exam). 6. Contraindications for MRI 7. Tested positive or has been treated for a malignancy in the past five years 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 8. Condition represents a worker's compensation case 9. Currently involved in a health-related litigation procedure 10. Is pregnant 11. Bleeding disorders 12. Currently taking anticoagulant or immunosuppressive medication 13. Allergy or intolerance to study medication 14. Use of chronic opioid 15. Documented history of drug abuse within six months of treatment 18\) Any other condition, that in the opinion of the investigator, that would preclude the patient from enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median change in protein concentration or percentage of cellular subpopulations | 6 weeks compared to baseline | A comparison of the patient temporal median change in protein concentration or percentage of cellular subpopulations from pre-injection to 6 weeks post- Regenexx SD treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Pain Scale from baseline to 6 weeks | 6 weeks | Mean Numeric Pain Scale |
| Mean Change in IKDC Scores from baseline to 6 weeks | 6 weeks | Mean Patient Reported Pain and Function Scale |
| Incidence and time to resolution of post-operative complications and adverse events | 6 weeks | Incidence and time to resolution of post-operative complications and adverse events |
| Incidence and time to re-injection/re-operation | 6 weeks | Incidence and time to re-injection/re-operation |
Countries
United States
Outcome results
None listed