A Controlled Surveillance of the Osteoarthritic Knee Microenvironment With Regenexx® SD Treatment
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|ClinicalTrials.gov Identifier: NCT02370823|
Recruitment Status : Terminated (Terminated early for poor study design.)
First Posted : February 25, 2015
Last Update Posted : March 30, 2018
|Condition or disease||Intervention/treatment|
|Osteoarthritis, Knee||Procedure: Regenexx SD|
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|
|Estimated Enrollment :||20 participants|
|Official Title:||A Controlled Surveillance of the Osteoarthritic Knee Microenvironment With Regenexx® SD Treatment|
|Study Start Date :||February 2015|
|Actual Primary Completion Date :||March 2018|
|Actual Study Completion Date :||March 2018|
Knee OA Treated with Regenexx SD
20 subjects with unilateral knee osteoarthritis. Collection of synovial fluid from both knees will serve as the experimental condition, i.e. the osteoarthritic knee, and the matched control, i.e. the knee not demonstrating signs of osteoarthritis. Alterations in the concentration of the synovial fluid proteins and cellular components will be evaluated up to 6 weeks post-Regenexx® SD - Same Day Bone Marrow Concentrate Injection treatment.
Procedure: Regenexx SD
stem cell treatment
Other Name: Bone Marrow Concentrate
- Median change in protein concentration or percentage of cellular subpopulations [ Time Frame: 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.
- Mean Change in Pain Scale from baseline to 6 weeks [ Time Frame: 6 weeks ]Mean Numeric Pain Scale
- Mean Change in IKDC Scores from baseline to 6 weeks [ Time Frame: 6 weeks ]Mean Patient Reported Pain and Function Scale
- Incidence and time to resolution of post-operative complications and adverse events [ Time Frame: 6 weeks ]Incidence and time to resolution of post-operative complications and adverse events
- Incidence and time to re-injection/re-operation [ Time Frame: 6 weeks ]Incidence and time to re-injection/re-operation
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02370823
|United States, Colorado|
|Broomfield, Colorado, United States, 80021|
|Principal Investigator:||Christopher Centeno, MD||Centeno-Schultz Clinic|