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.
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.
Study Type
OBSERVATIONAL
Enrollment
20
stem cell treatment
Centeno-Schultz Clinic
Broomfield, Colorado, United States
Median change in protein concentration or percentage of cellular subpopulations
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.
Time frame: 6 weeks compared to baseline
Mean Change in Pain Scale from baseline to 6 weeks
Mean Numeric Pain Scale
Time frame: 6 weeks
Mean Change in IKDC Scores from baseline to 6 weeks
Mean Patient Reported Pain and Function Scale
Time frame: 6 weeks
Incidence and time to resolution of post-operative complications and adverse events
Incidence and time to resolution of post-operative complications and adverse events
Time frame: 6 weeks
Incidence and time to re-injection/re-operation
Incidence and time to re-injection/re-operation
Time frame: 6 weeks
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