Celution Prepared Adipose Derived Regenerative Cells in the Treatment of Osteoarthritis of the Knee
NCT ID: NCT02326961
Last Updated: 2016-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
94 participants
INTERVENTIONAL
2015-01-31
2016-10-31
Brief Summary
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Detailed Description
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Subjects that have chronic knee pain due to idiopathic osteoarthritis of the knee (confirmed clinically and radiologically) will be evaluated for eligibility in this study. Following informed consent and screening evaluations, eligible subjects will undergo pre-operative testing. Subjects will then undergo fat harvest through small volume liposuction under local anesthesia. Lipoaspirate will be processed in the Celution System to isolate and concentrate ADRCs for immediate intraarticular administration. A dose escalation approach has been designed wherein the study is divided into two double-blind, randomized, placebo-controlled parts as follows:
Part A:
Low Dose (20,000,000 cells): 30 patients OR Placebo: 15 patients
Part B:
High Dose (40,000,000 cells): 30 patients OR Placebo: 15 patients
Subjects randomized to placebo will undergo fat harvest and intraarticular injection of a placebo that has been visually matched to the active test substance. All subjects will undergo imaging studies, clinical evaluations, and laboratory testing prior to and after the procedure; patients will be followed for 48 weeks after intraarticular injections are performed.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Celution ADRCs; Low Dose
Adipose Derived Regenerative Cells (ADRCs) processed by the Celution Device 20,000,000 ADRCs per single intraarticular administration
Celution Device
ADRCs Prepared using the Celution Device
Celution ADRCs; High Dose
Adipose Derived Regenerative Cells (ADRCs) processed by the Celution Device 40,000,000 ADRCs per single intraarticular administration
Celution Device
ADRCs Prepared using the Celution Device
Placebo
Sterile Lactated Ringers Solution (5mL) mixed with ≤ 0.20 ml of the study subject's own freshly drawn blood.
Placebo
Inactive Placebo
Interventions
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Celution Device
ADRCs Prepared using the Celution Device
Placebo
Inactive Placebo
Eligibility Criteria
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Inclusion Criteria
2. Able to provide written informed consent
3. Diagnosis of osteoarthritis in one or both knees by American College of Rheumatology (ACR) criteria
4. Kellgren and Lawrence grade 2 or 3 (standing AP x-ray) of the target knee within the preceding 6 months
5. Pain due to osteoarthritis in the target knee ≥ 6 months
6. Minimum score of "moderate" from KOOS question about pain on walking on a flat surface.
7. Minimum score of "moderate" from KOOS question about degree of difficulty during walking on a flat surface.
8. Continued knee pain and limitations in knee function despite prescription of conservative therapy for at least 6 months.
9. Ability to safely undergo liposuction that will result in the harvest of a sufficient quantity of adipose tissue (approximately 300 mL)
10. 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).
11. Ability to perform procedures required of the pain index evaluations (unassisted walking 50 feet on a flat surface and going up and down stairs)
Exclusion Criteria
2. Need for cane or other assistance device for walking
3. 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
4. Prior articular transplant procedures
5. Prior ligament reconstruction to the target knee within 12 months prior to the screening visit
6. Inflammatory arthropathies such as rheumatoid arthritis, lupus arthropathy, or psoriatic arthritis
7. Gout or calcium pyrophosphate (pseudogout) diseases that have flared within the previous 6 months prior to the screening visit
8. 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)
9. Fibromyalgia, pes anserine bursitis, lumbar radiculopathy, and/or neurogenic or vascular claudication
10. Primary knee pain due to diagnosed isolated patella-femoral arthritis or chondromalacia in the target knee
11. Significant target knee joint infection or skin disorder/infection within the previous 6 months prior to the screening visit
12. Symptomatic OA of the hips, spine, or ankle, if it would interfere with the evaluation of the target knee
13. Any condition requiring immunosuppressive medication or use of systemic steroids
14. 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
15. 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
16. Participation in any experimental drug or device study within the 6 months prior to the screening visit
17. Obesity defined as BMI \> 35 kg/m2
40 Years
69 Years
ALL
No
Sponsors
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Cytori Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Steven Kesten, MD
Role: STUDY_DIRECTOR
Cytori Therapeutics
Locations
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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
Countries
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Other Identifiers
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ACT-OA Knee
Identifier Type: -
Identifier Source: org_study_id