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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 : December 27, 2021
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 )

Study Description
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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).

Condition or disease Intervention/treatment Phase
Recovery Following Partial Medial Meniscectomy Drug: Mesenchymal Stem Cells Drug: Hyaluronan Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2005
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Chondrogen - dose 1
Chondrogen - 50 million cells
 Drug: Mesenchymal Stem Cells
Active Comparator: Chondrogen - dose 2
Chondrogen - 150 million cells
 Drug: Mesenchymal Stem Cells
Vehicle Control
Vehicle Control
 Drug: Hyaluronan


Outcome Measures
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Primary Outcome Measures :
  1. Meniscal Volume [ Time Frame: 6 months ]
    Changes in meniscal volume over the course of the study as determined by MRI


Secondary Outcome Measures :
  1. Quality of Life Questionnaire [ Time Frame: 2 years ]
    Determination of Quality of Life will be measured by the KOOS instrument (Knee injury and Osteoarthritis Outcome Score).

  2. Visual Analog Scale (VAS) [ Time Frame: Baseline to 2 years ]
    Patient perception of pain will be documented using a single VAS pain scale.

  3. Lysholm Knee Scale [ Time Frame: 2 years ]
    Lysholm knee score will be determined according to the questionnaire

  4. Safety Assessment Adverse Event [ Time Frame: 2 years ]
    Number of participants with Adverse Events.

  5. Safety Assessment Immunological [ Time Frame: 2 years ]
    Number of participants with clinically significant abnormalities in immunological measures

  6. Safety Assessment Laboratory [ Time Frame: 2 years ]
    Number of participants with clinically significant abnormalities in laboratory assessments

  7. Safety Assessment Physical Exam [ Time Frame: 2 years ]
    Number of participants with clinically significant abnormalities in physical examinations.

  8. Safety Assessment Magnetic Resonance Imaging (MRI) [ Time Frame: 2 years ]
    Number of participants with clinically significant abnormalities in Magnetic Resonance Imaging (MRI).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00225095


Locations
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United States, California
University of Southern California
Los Angeles, California, United States, 90033
United States, Florida
Orthopedic Center of Vero Beach
Vero Beach, Florida, United States, 32960
United States, Illinois
Midwest Orthopaedics at Rush
Chicago, Illinois, United States, 60612
United States, Indiana
Ortholndy
Indianapolis, Indiana, United States, 46237
United States, Maryland
Greater Chesapeake Associates
Baltimore, Maryland, United States, 21218
United States, Minnesota
TRIA Orthopaedic Center
Bloomington, Minnesota, United States, 55431
United States, North Carolina
Triangle Orthopaedics Associates, P.A.
Durham, North Carolina, United States, 27704
United States, Texas
Unlimited Research
San Antonio, Texas, United States, 78233
Sponsors and Collaborators
Mesoblast International Sàrl
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
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Study Director: Michelle Williams, Ph.D. Osiris Therapeutics, Inc.
More Information
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Mesoblast International Sàrl
ClinicalTrials.gov Identifier: NCT00225095    
Other Study ID Numbers: Osiris 550
First Posted: September 23, 2005    Key Record Dates
Last Update Posted: December 27, 2021
Last Verified: December 2021
Keywords provided by Mesoblast, Ltd. ( Mesoblast International Sàrl ):
meniscectomy
Chondrogen
Mesenchymal Stem Cells
Osiris
Additional relevant MeSH terms:
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Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
 Physiological Effects of Drugs
Viscosupplements
Protective Agents