Knee OA Treated with Regenexx SD for Osteoarthritis

N/A

Waitlist Available

Led By Christopher Centeno, MD

Research Sponsored by Regenexx, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Awards & highlights

No Placebo-Only Group

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.

Eligible Conditions

Osteoarthritis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Median change in protein concentration or percentage of cellular subpopulations

Secondary study objectives

Incidence and time to re-injection/re-operation

Incidence and time to resolution of post-operative complications and adverse events

Mean Change in IKDC Scores from baseline to 6 weeks

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Knee OA Treated with Regenexx SDExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Regenexx SD

2013

N/A

~150

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