NCT02326961

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 30, 2014

Completed
2 days until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

October 28, 2016

Status Verified

October 1, 2016

Enrollment Period

1.4 years

First QC Date

November 19, 2014

Last Update Submit

October 26, 2016

Conditions

Osteoarthritis, Knee

Keywords

osteoarthritiskneeadipose derived regenerative cellsADRCCelutionarthritis

Outcome Measures

Primary Outcomes (1)

  • Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain on Walking

    12 Weeks

Secondary Outcomes (8)

  • Observed Pain Scores on 50-foot Walk Test

    48 Weeks

  • Number of Observed OARS130 Responders

    48 Weeks

  • Knee Injury and Osteoarthritis Outcome Score (KOOS)

    48 Weeks

  • VAS Assessments

    48 Weeks

  • Patient Global Assessment

    48 Weeks

  • +3 more secondary outcomes

Other Outcomes (1)

  • Adverse Events, Serious Adverse Events, and UADEs

    48 Weeks

Study Arms (3)

Celution ADRCs; Low Dose

EXPERIMENTAL

Adipose Derived Regenerative Cells (ADRCs) processed by the Celution Device 20,000,000 ADRCs per single intraarticular administration

Device: Celution Device

Celution ADRCs; High Dose

EXPERIMENTAL

Adipose Derived Regenerative Cells (ADRCs) processed by the Celution Device 40,000,000 ADRCs per single intraarticular administration

Device: Celution Device

Placebo

PLACEBO COMPARATOR

Sterile Lactated Ringers Solution (5mL) mixed with ≤ 0.20 ml of the study subject's own freshly drawn blood.

Other: Placebo

Interventions

Celution DeviceDEVICE

ADRCs Prepared using the Celution Device

Celution ADRCs; High DoseCelution ADRCs; Low Dose
PlaceboOTHER

Inactive Placebo

Placebo

Eligibility Criteria

Age40 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Arizona Arthritis and Rheumatology Research, PLLC

Mesa, Arizona, 85202, United States

Location

Baptist Health Center for Clinical Research

Little Rock, Arkansas, 72205, United States

Location

BioSolutions Clinical Research Center

La Mesa, California, 91942, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Heartland Research Associates

Wichita, Kansas, 67207, United States

Location

Central Kentucky Research Associates

Lexington, Kentucky, 40509, United States

Location

Covington Orthopedic and Sports Medicine Institute

Covington, Louisiana, 70433, United States

Location

Arthritis Treatment Center

Frederick, Maryland, 21702, United States

Location

Center for Pharmaceutical Research

Kansas City, Missouri, 64114, United States

Location

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritisArthritis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Steven Kesten, MD

    Cytori Therapeutics

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2014

First Posted

December 30, 2014

Study Start

January 1, 2015

Primary Completion

June 1, 2016

Study Completion

October 1, 2016

Last Updated

October 28, 2016

Record last verified: 2016-10

Locations

US(11)