Celution Prepared Adipose Derived Regenerative Cells in the Treatment of Osteoarthritis of the Knee

Completed · Phase 2 · Has a placebo group

Conditions studied: Osteoarthritis, Knee

In brief

The primary objective of this study is to evaluate the safety and feasibility of intraarticular injection of Celution prepared adipose-derived regenerative cells injected into knees of patients with chronic knee pain due to osteoarthritis.

Key facts

Study ID

NCT02326961

Run by

Cytori Therapeutics

People needed

94

Starts

2015-01-01

Expected to finish

2016-10-01

Last updated by the study team

2016-10-28

Who can join

Age: 40 and older, up to 69. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or females ≥ 40 and < 70 years of age
• Able to provide written informed consent
• Diagnosis of osteoarthritis in one or both knees by American College of Rheumatology (ACR) criteria
• Kellgren and Lawrence grade 2 or 3 (standing AP x-ray) of the target knee within the preceding 6 months
• Pain due to osteoarthritis in the target knee ≥ 6 months
• Minimum score of "moderate" from KOOS question about pain on walking on a flat surface.
• Minimum score of "moderate" from KOOS question about degree of difficulty during walking on a flat surface.
• Continued knee pain and limitations in knee function despite prescription of conservative therapy for at least 6 months.
• Ability to safely undergo liposuction that will result in the harvest of a sufficient quantity of adipose tissue (approximately 300 mL)
• On stable regimen of one analgesic medication (rescue medication) for their knee pain due to osteoarthritis and ability and willingness to use the same analgesic medication during the study (screening period through to final study visit).
• Ability to perform procedures required of the pain index evaluations (unassisted walking 50 feet on a flat surface and going up and down stairs)

You may not qualify if…

• Any major injury to the target knee within the 12 months prior to the screening visit
• Need for cane or other assistance device for walking
• Any surgery to the target knee within the 6 months prior to the screening visit, or surgery to the contralateral knee or other weight-bearing joint if it will interfere with knee assessments
• Prior articular transplant procedures
• Prior ligament reconstruction to the target knee within 12 months prior to the screening visit
• Inflammatory arthropathies such as rheumatoid arthritis, lupus arthropathy, or psoriatic arthritis
• Gout or calcium pyrophosphate (pseudogout) diseases that have flared within the previous 6 months prior to the screening visit
• X-ray findings of acute fractures, known severe loss of bone density (as determined by the investigator), avascular necrosis, and/or severe bone or joint deformity in the target knee (>5 degree valgus or varus deviation from mechanical axis)
• Fibromyalgia, pes anserine bursitis, lumbar radiculopathy, and/or neurogenic or vascular claudication
• Primary knee pain due to diagnosed isolated patella-femoral arthritis or chondromalacia in the target knee
• Significant target knee joint infection or skin disorder/infection within the previous 6 months prior to the screening visit
• Symptomatic OA of the hips, spine, or ankle, if it would interfere with the evaluation of the target knee
• Any condition requiring immunosuppressive medication or use of systemic steroids
• Intra-articular injection of steroids in previous 3 months or hyaluronic acid in previous 6 months in one or both knees prior to the screening visit
• Patients that have received PRP, other platelet-based product, or investigational treatment in another cell/biologic study for the targeted treatment injury in the 12 months prior to the injection procedure
• Participation in any experimental drug or device study within the 6 months prior to the screening visit
• Obesity defined as BMI > 35 kg/m2

Where it is running

• Arizona Arthritis and Rheumatology Research, PLLC — Mesa, Arizona, United States
• Baptist Health Center for Clinical Research — Little Rock, Arkansas, United States
• BioSolutions Clinical Research Center — La Mesa, California, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Heartland Research Associates — Wichita, Kansas, United States
• Central Kentucky Research Associates — Lexington, Kentucky, United States
• Covington Orthopedic and Sports Medicine Institute — Covington, Louisiana, United States
• Arthritis Treatment Center — Frederick, Maryland, United States
• Center for Pharmaceutical Research — Kansas City, Missouri, United States
• Hospital for Special Surgery — New York, New York, United States
• Altoona Center for Clinical Research — Duncansville, Pennsylvania, United States

Full record on ClinicalTrials.gov

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