A Controlled Surveillance of the Osteoarthritic Knee Microenvironment With Regenexx® SD Treatment

Study Overview
=================
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.

Official Title
-----------------
A Controlled Surveillance of the Osteoarthritic Knee Microenvironment With Regenexx® SD Treatment

Conditions
-----------------
Osteoarthritis, Knee

Intervention / Treatment
-----------------
* Procedure: Regenexx SD


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Voluntary signature of the IRB approved Informed Consent Unilateral osteoarthritic male or female ages 35-85 Pain, swelling, and/or functional disability in the affected knee consistent with osteoarthritis in one knee joint Physical examination consistent with osteoarthritis in one knee joint Restricted range of motion of the affected knee (<135 degrees in flexion and/or >0 degrees of extension) Kellgren-Lawrence grade 2 or greater knee osteoarthritis with diagnostic MR imaging of the affected knee showing osteoarthritis Limited knee effusion in osteoarthritic knee (i.e. not more than 20 ml of visible joint fluid on ultrasound examination of the knee.) Normal range of motion of the unaffected knee No sign of pain, swelling, and/or functional disability of the unaffected knee No history of acute injury in the unaffected knee Is independent, ambulatory, and can comply with all post-operative evaluations and visits Exclusion Criteria: Knee injections of any type within 6 months prior to the study. 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) Quinolone or Statin induced myopathy/tendinopathy Symptomatic lumbar spine pathology (e.g. radicular pain) 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). Contraindications for MRI 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 Condition represents a worker's compensation case Currently involved in a health-related litigation procedure Is pregnant Bleeding disorders Currently taking anticoagulant or immunosuppressive medication Allergy or intolerance to study medication Use of chronic opioid 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

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Knee OA Treated with Regenexx SD<br>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<br>* stem cell treatment<br>* Other names: Bone Marrow Concentrate;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 weeks compared to baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in Pain Scale from baseline to 6 weeks | Mean Numeric Pain Scale | 6 weeks | 
| Mean Change in IKDC Scores from baseline to 6 weeks | Mean Patient Reported Pain and Function Scale | 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 | 6 weeks | 
| Incidence and time to re-injection/re-operation | Incidence and time to re-injection/re-operation | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoarthritis, Knee