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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02370823
Study type Observational
Source Regenerative Sciences, LLC
Contact
Status Terminated
Phase
Start date February 2015
Completion date March 2018

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