Celution Prepared Adipose Derived Regenerative Cells in the Treatment of Osteoarthritis of the Knee (ACT-OA Knee)

• ClinicalTrials.gov Identifier: NCT02326961
• Recruitment Status: Completed
• First Posted: December 30, 2014
• Last Update Posted: October 28, 2016
• Sponsor: Cytori Therapeutics
• Information provided by (Responsible Party): Cytori Therapeutics

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Osteoarthritis, Knee	Device: Celution Device; Other: Placebo	Phase 2

Detailed Description:

The ACT - OA Knee Clinical Trial is a prospective, randomized, multi-center device trial intended to assess safety and feasibility of intraarticular administration of Celution processed Adipose Derived Regenerative Cells (ADRCs). The study will include 90 patients in up to 15 sites in the United States.

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 94 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Celution Prepared Adipose Derived Regenerative Cells in the Treatment of Osteoarthritis of the Knee: A Double-blind, Placebo Controlled, Multi-center Safety and Feasibility Study
• Study Start Date: January 2015
• Actual Primary Completion Date: June 2016
• Actual Study Completion Date: October 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: Celution ADRCs; Low Dose; Adipose Derived Regenerative Cells (ADRCs) processed by the Celution Device 20,000,000 ADRCs per single intraarticular administration	Device: Celution Device; ADRCs Prepared using the Celution Device
Experimental: Celution ADRCs; High Dose; Adipose Derived Regenerative Cells (ADRCs) processed by the Celution Device 40,000,000 ADRCs per single intraarticular administration	Device: Celution Device; ADRCs Prepared using the Celution Device
Placebo Comparator: Placebo; Sterile Lactated Ringers Solution (5mL) mixed with ≤ 0.20 ml of the study subject's own freshly drawn blood.	Other: Placebo; Inactive Placebo

Outcome Measures

Primary Outcome Measures :

1. Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain on Walking [ Time Frame: 12 Weeks ]

Secondary Outcome Measures :

1. Observed Pain Scores on 50-foot Walk Test [ Time Frame: 48 Weeks ]
2. Number of Observed OARS130 Responders [ Time Frame: 48 Weeks ]
3. Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: 48 Weeks ]
4. VAS Assessments [ Time Frame: 48 Weeks ]
5. Patient Global Assessment [ Time Frame: 48 Weeks ]
6. Use of Rescue Medication [ Time Frame: 48 Weeks ]
7. SF-36 Questionnaire [ Time Frame: 48 Weeks ]
8. MRI Osteoarthritis Knee Score [ Time Frame: 48 Weeks ]

Other Outcome Measures:

1. Adverse Events, Serious Adverse Events, and UADEs [ Time Frame: 48 Weeks ]

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 69 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Males or females ≥ 40 and < 70 years of age
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:

1. Any major injury to the target knee within the 12 months prior to the screening visit
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

Contacts and Locations

Locations

United States, Arizona

Arizona Arthritis and Rheumatology Research, PLLC

Mesa, Arizona, United States, 85202

United States, Arkansas

Baptist Health Center for Clinical Research

Little Rock, Arkansas, United States, 72205

United States, California

BioSolutions Clinical Research Center

La Mesa, California, United States, 91942

United States, Illinois

Rush University Medical Center

Chicago, Illinois, United States, 60612

United States, Kansas

Heartland Research Associates

Wichita, Kansas, United States, 67207

United States, Kentucky

Central Kentucky Research Associates

Lexington, Kentucky, United States, 40509

United States, Louisiana

Covington Orthopedic and Sports Medicine Institute

Covington, Louisiana, United States, 70433

United States, Maryland

Arthritis Treatment Center

Frederick, Maryland, United States, 21702

United States, Missouri

Center for Pharmaceutical Research

Kansas City, Missouri, United States, 64114

United States, New York

Hospital for Special Surgery

New York, New York, United States, 10021

United States, Pennsylvania

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States, 16635

Sponsors and Collaborators

Cytori Therapeutics

Investigators

• Study Director: Steven Kesten, MD; Cytori Therapeutics

More Information

• Responsible Party: Cytori Therapeutics
• ClinicalTrials.gov Identifier: NCT02326961
• Other Study ID Numbers: ACT-OA Knee
• First Posted: December 30, 2014
• Last Update Posted: October 28, 2016
• Last Verified: October 2016

Keywords provided by Cytori Therapeutics:

osteoarthritis; knee; adipose derived regenerative cells; ADRC; Celution; arthritis

Additional relevant MeSH terms:

Osteoarthritis; Osteoarthritis, Knee; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases