Investigation of Mesenchymal Stem Cell Therapy for the Treatment of Osteoarthritis of the Knee: Effect on Pain and Quality of Life

OhioHealth1 site in 1 country32 target enrollmentDecember 2016

ConditionsKnee Osteoarthritis

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Knee Osteoarthritis
Sponsor: OhioHealth
Enrollment: 32
Locations: 1
Primary Endpoint: Knee Injury and Osteoarthritis Outcome Score
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine the clinical response to autologous bone marrow aspirate concentrate (BMAC) and platelet-rich plasma (PRP) injections for knee osteoarthritis with respect to pain, function, and quality of life at up to 1 year following the intervention. Specifically, the clinical response will be compared to baseline and a control group treated with a Gel-One® hyaluronate injection to the target knee.

Registry

clinicaltrials.gov

Start Date

December 2016

End Date

August 2018

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

OhioHealth

Responsible Party

Principal Investigator

Joseph Ruane

Principal Investigator - Medical Director, McConnell Heart Health Center

OhioHealth

Eligibility Criteria

Inclusion Criteria

•Male and female patients 40 to 70 years old
•Diagnosed with knee osteoarthritis based on the American College of Rheumatology criteria including symptomatic reports and radiographic findings
•Kellgren-Lawrence grade 1-3 based on a radiograph within 6 months of presentation to the clinic
•Symptomatic evidence of tibiofemoral osteoarthritis for ≥6 months
•Average numeric pain rating of 4 - 8 on a scale of zero to 10 (defined as moderate level) over the past week
•Previous trial of 6 weeks minimum of conservative therapy including physical therapy, weight loss, anti-inflammatory medication, or injection therapy

Exclusion Criteria

•Grade 4 knee osteoarthritis according to the Kellgren-Lawrence scale
•History of intraarticular viscosupplementation or steroid injection in the target knee in the past 6 months at the time of the baseline visit or intraarticular injection planned during the trial
•History of arthroscopic surgery in the target knee in the past 12 months at the time of presentation to the clinic or planned surgery during the trial period (e.g., scheduled for/awaiting arthroscopy or a knee replacement procedure)
•Bilateral knee osteoarthritis (unless the contralateral knee involvement is limited to radiographic osteoarthritis and not symptomatic)
•Ipsilateral (same side) or contralateral (opposite side) symptomatic osteoarthritis of hip or ankle
•Clinically apparent tense effusion or other acute inflammation of the target knee at the time of presentation to the clinic
•Active infection of either lower extremity such as cellulitis or any skin disease or infection in the area where BMAC is aspirated, blood is drawn, or an injection is given
•History of diagnosis of any of the following: 1) septic osteoarthritis of any joint, 2) inflammatory arthropathy such as rheumatoid arthritis, gout, pseudogout, lupus, crystalline arthropathy, chondrocalcinosis and other rheumatology diagnoses
•Cruciate/collateral knee ligament instability, ligament laxity, or meniscal instability of the target knee
•Significant alignment deformity such as varus/valgus of the target knee in the judgment of the investigator

Outcomes

Primary Outcomes

Knee Injury and Osteoarthritis Outcome Score

Time Frame: Change from baseline to 3, 6, and 12 months post-treatment

Subscales include pain, symptoms, function in activities of daily living, function in sport and recreation, and knee-related quality of life. Each subscale is 0-100 with 100 indicating the best possible score.

Secondary Outcomes

Numeric Pain Rating Scale(Change from baseline to 3, 6, and 12 months post-treatment)
Patient Reported Outcome Measurement Information System Global Health Scores(Change from baseline to 3, 6, and 12 months post-treatment)