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

Osteoarthritis, Knee Clinical Trial

— ACT-OA Knee  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02326961
• Other study ID #: ACT-OA Knee
• Status: Completed
• Phase: Phase 2
• First received: November 19, 2014
• Last updated: October 26, 2016
• Start date: January 2015
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: Cytori Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review BoardUnited States: Data and Safety Monitoring Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: October 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 69 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Celution Device
ADRCs Prepared using the Celution Device

Other:
• Placebo
Inactive Placebo

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Cytori Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse Events, Serious Adverse Events, and UADEs		48 Weeks	Yes
Primary	Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain on Walking		12 Weeks	No
Secondary	Observed Pain Scores on 50-foot Walk Test		48 Weeks	No
Secondary	Number of Observed OARS130 Responders		48 Weeks	No
Secondary	Knee Injury and Osteoarthritis Outcome Score (KOOS)		48 Weeks	No
Secondary	VAS Assessments		48 Weeks	No
Secondary	Patient Global Assessment		48 Weeks	No
Secondary	Use of Rescue Medication		48 Weeks	No
Secondary	SF-36 Questionnaire		48 Weeks	No
Secondary	MRI Osteoarthritis Knee Score		48 Weeks	No