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A Phase I/II Study of Chondrogen Delivered by Intra-Articular Injection Following Meniscectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00225095
Recruitment Status : Completed
First Posted : September 23, 2005
Last Update Posted : June 2, 2020
Sponsor:
Collaborators:
University of Southern California
Midwest Orthopedics at Rush - Chicago, IL
Unlimited Research - San Antonio, TX
Triangle Orthopaedic Associates, P.A.
Orthopedic Center of Vero Beach - Vero Beach, FL
OrthoIndy
TRIA Orthopaedic Center
Greater Chesapeake Orthopaedic Associates, LLC
Information provided by (Responsible Party):
Mesoblast, Ltd. ( Mesoblast International Sàrl )

Tracking Information
First Submitted Date  ICMJE September 21, 2005
First Posted Date  ICMJE September 23, 2005
Last Update Posted Date June 2, 2020
Study Start Date  ICMJE September 2005
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 2, 2014)
meniscal volume [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 21, 2005)
  • meniscal volume
  • adverse events
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2014)
  • quality of life [ Time Frame: 2 years ]
  • immunological endpoints [ Time Frame: Baseline to 2 years ]
  • Safety [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2005)
  • quality of life
  • immunological endpoints
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase I/II Study of Chondrogen Delivered by Intra-Articular Injection Following Meniscectomy
Official Title  ICMJE A Phase I/II, Randomized, Controlled, Double Blind, Study of Chondrogen - Adult Universal Cell Delivered by Intra-Articular Injection Following Meniscectomy in Patients 18-60 Years
Brief Summary The purpose of this study is to determine whether Chondrogen is a safe and effective post-operative treatment of the knee following menisectomy (the surgical removal of all or part of a torn meniscus).
Detailed Description

Chondrogen is a preparation of adult mesenchymal stem cells (MSCs) in a solution containing hyaluronic acid. Preclinical studies have shown that injection of Chondrogen aids in the repair of meniscal tissue following meniscectomy. In Chondrogen treated subjects, surgically removed meniscal tissue was regenerated, cartilage surface was protected, and joint damage was decreased in comparison to control subjects. These benefits persisted at least one year.

Three groups of recent meniscectomy patients will be followed in this study, including patients that will receive placebo and patients that will be treated with one of two possible doses of Chondrogen.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Recovery Following Partial Medial Meniscectomy
Intervention  ICMJE
  • Drug: Mesenchymal Stem Cells
  • Drug: Hyaluronan
Study Arms  ICMJE
  • Active Comparator: Chondrogen - dose 1
    Chondrogen - 50 million cells
    Intervention: Drug: Mesenchymal Stem Cells
  • Active Comparator: Chondrogen - dose 2
    Chondrogen - 150 million cells
    Intervention: Drug: Mesenchymal Stem Cells
  • Vehicle Control
    Vehicle Control
    Intervention: Drug: Hyaluronan
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 21, 2005)
60
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2008
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 18 to 60, inclusive
  • In need of medial meniscectomy
  • Normal axial alignment
  • Stable knee- previous ligament reconstruction, if stable
  • Removal of at least 50% of the affected portion of the medial meniscus
  • Intact articular cartilage in posterior meniscal weight-bearing zone
  • Willingness to follow normal post-operative rehabilitation
  • Willingness to participate in follow-up for two years from the time of meniscectomy surgery
  • Ability to understand and willingness to sign consent form

Exclusion Criteria:

  • Pregnant or lactating
  • ACL or other support structure damage confirmed at surgery
  • Grade III or IV cartilage damage (Cartilage loss greater than 50% thickness in area >15mm on weight-bearing aspect of femoral condyle or tibial plateau)
  • Synvisc, steroid, or corticosteroid injections in preceding 3 months
  • Diffuse synovitis at time of arthroscopy
  • Inflammatory arthritis
  • Oral steroid, methotrexate therapy
  • Unable to follow post-operative exercise regimen or return for evaluations
  • Active alcohol or substance abuse within 6 months of study entry
  • Current and active tobacco product use
  • Patient is positive for HIV
  • Patient is positive for hepatitis (past history of Hepatitis A is allowed)
  • Any medical condition, which in the opinion of the clinical investigator, would interfere with the treatment or outcome of the patient
  • Indwelling pacemaker
  • Cerebral aneurysm clips
  • Ear, eye and penile implants with avian components
  • Electrical indwelling device such as bone stimulator
  • Indwelling magnets as tissue expander for future implants
  • Known allergy to avian, bovine or porcine protein
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00225095
Other Study ID Numbers  ICMJE Osiris 550
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mesoblast, Ltd. ( Mesoblast International Sàrl )
Study Sponsor  ICMJE Mesoblast International Sàrl
Collaborators  ICMJE
  • University of Southern California
  • Midwest Orthopedics at Rush - Chicago, IL
  • Unlimited Research - San Antonio, TX
  • Triangle Orthopaedic Associates, P.A.
  • Orthopedic Center of Vero Beach - Vero Beach, FL
  • OrthoIndy
  • TRIA Orthopaedic Center
  • Greater Chesapeake Orthopaedic Associates, LLC
Investigators  ICMJE
Study Director: Michelle Williams, Ph.D. Osiris Therapeutics, Inc.
PRS Account Mesoblast, Ltd.
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP