Investigation of Mesenchymal Stem Cell Therapy for the Treatment of Osteoarthritis of the Knee

Phase 2

Completed

Conditions: Knee Osteoarthritis

Interventions: Biological: BMAC injection
Device: Gel-One® hyaluronate injection
Biological: PRP injection

Registration Number: NCT02958267

Lead Sponsor: OhioHealth

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 32

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
Currently pregnant, nursing, or planning to become pregnant during the trial period
Previous or known allergic reaction or hypersensitivity to heparin; sodium citrate; hyaluronan products or specifically Gel-One®; cinnamon; bird products such as feathers, eggs, or poultry; avian proteins
Not suitable for BMAC tissue allograft injection per physician (e.g., blood dyscrasia)
Unable to be prescribed stable dose of NSAIDs and/or tramadol based on medical history as ad lib use of over-the-counter analgesics will be allowed in both groups after treatment
Current cigarette smoker
Unable to give informed consent
Non-English speaking

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BMAC injection and PRP injection	BMAC injection	Injection of bone marrow aspirate concentrate (BMAC) withdrawn from a bone near the hip into the knee joint (intra-articular) immediately followed by an injection of platelet-rich plasma (PRP) into the knee joint.
BMAC injection and PRP injection	PRP injection	Injection of bone marrow aspirate concentrate (BMAC) withdrawn from a bone near the hip into the knee joint (intra-articular) immediately followed by an injection of platelet-rich plasma (PRP) into the knee joint.
Gel-One® hyaluronate injection	Gel-One® hyaluronate injection	Gel-One® is an hyaluronate gel used in the treatment of knee osteoarthritis by injection into the knee joint (intra-articular).

Primary Outcome Measures

Name	Time	Method
Knee Injury and Osteoarthritis Outcome Score	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 Outcome Measures

Name	Time	Method
Numeric Pain Rating Scale	Change from baseline to 3, 6, and 12 months post-treatment	Scale from 0-10 with 0 representing "no pain" and 10 representing "worst imaginable pain"
Patient Reported Outcome Measurement Information System Global Health Scores	Change from baseline to 3, 6, and 12 months post-treatment	The Patient Reported Outcomes Measurement Information System (PROMIS®) Global Health scale v1.1 contains 10 questions and produces two subscale scores: Global Physical Health (GPH) and Global Mental Health (GMH) (Hays, Bjorner, Revicki, Spritzer, \& Cella, 2009). Each subscale produces a raw score that is converted to a T score such that an average patient in the United States would have a subscale T score of 50 with a standard deviation of 10 points ("Global Health: A Brief Guide to the PROMIS® Global Health Instruments", 2017). A score higher than the mean indicates a more desirable score, and vice versa. A positive change score indicates an improvement, while a negative change score indicates a decline in score value.