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CompletedNCT00225095Updated Dec 27, 2021

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

A Phase 1/2 interventional study of Mesenchymal Stem Cells and Hyaluronan in Recovery Following Partial Medial Meniscectomy, sponsored by Mesoblast International Sàrl. Completed at 8 sites in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2021-12-27.

Sponsored by Mesoblast International Sàrl · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Recovery Following Partial Medial Meniscectomy

Keywords

  • meniscectomy
  • Chondrogen
  • Mesenchymal Stem Cells
  • Osiris
03

In context

Lead sponsor

Mesoblast International Sàrl is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • 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

  • Other
    Vehicle Control

    Vehicle Control

    Drug: Hyaluronan

Interventions

  • DrugMesenchymal Stem Cells
  • DrugHyaluronan
06

What researchers measure

Primary outcomes

  1. Meniscal Volume

    Changes in meniscal volume over the course of the study as determined by MRI

    Time frame: 6 months

Secondary outcomes

  1. Quality of Life Questionnaire

    Determination of Quality of Life will be measured by the KOOS instrument (Knee injury and Osteoarthritis Outcome Score).

    Time frame: 2 years

  2. Visual Analog Scale (VAS)

    Patient perception of pain will be documented using a single VAS pain scale.

    Time frame: Baseline to 2 years

  3. Lysholm Knee Scale

    Lysholm knee score will be determined according to the questionnaire

    Time frame: 2 years

  4. Safety Assessment Adverse Event

    Number of participants with Adverse Events.

    Time frame: 2 years

  5. Safety Assessment Immunological

    Number of participants with clinically significant abnormalities in immunological measures

    Time frame: 2 years

  6. Safety Assessment Laboratory

    Number of participants with clinically significant abnormalities in laboratory assessments

    Time frame: 2 years

  7. Safety Assessment Physical Exam

    Number of participants with clinically significant abnormalities in physical examinations.

    Time frame: 2 years

  8. Safety Assessment Magnetic Resonance Imaging (MRI)

    Number of participants with clinically significant abnormalities in Magnetic Resonance Imaging (MRI).

    Time frame: 2 years

07

Study locations

8 sites
  • University of Southern California
    Los Angeles, California 90033, United States
  • Orthopedic Center of Vero Beach
    Vero Beach, Florida 32960, United States
  • Midwest Orthopaedics at Rush
    Chicago, Illinois 60612, United States
  • Ortholndy
    Indianapolis, Indiana 46237, United States
  • Greater Chesapeake Associates
    Baltimore, Maryland 21218, United States
  • TRIA Orthopaedic Center
    Bloomington, Minnesota 55431, United States
  • Triangle Orthopaedics Associates, P.A.
    Durham, North Carolina 27704, United States
  • Unlimited Research
    San Antonio, Texas 78233, United States
08

References and documents

Publications

  • Pittenger MF, Mackay AM, Beck SC, Jaiswal RK, Douglas R, Mosca JD, Moorman MA, Simonetti DW, Craig S, Marshak DR. Multilineage potential of adult human mesenchymal stem cells. Science. 1999 Apr 2;284(5411):143-7. doi: 10.1126/science.284.5411.143. PubMed 10102814 ↗
  • Murphy JM, Fink DJ, Hunziker EB, Barry FP. Stem cell therapy in a caprine model of osteoarthritis. Arthritis Rheum. 2003 Dec;48(12):3464-74. doi: 10.1002/art.11365. PubMed 14673997 ↗
  • Vangsness CT Jr, Farr J 2nd, Boyd J, Dellaero DT, Mills CR, LeRoux-Williams M. Adult human mesenchymal stem cells delivered via intra-articular injection to the knee following partial medial meniscectomy: a randomized, double-blind, controlled study. J Bone Joint Surg Am. 2014 Jan 15;96(2):90-8. doi: 10.2106/JBJS.M.00058. PubMed 24430407 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 27, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00225095
Lead sponsor
Mesoblast International Sàrl
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
Responsible party
Sponsor
First posted
Sep 23, 2005
Start date
Sep 2005
Primary completion
Apr 2008
Completion
Apr 2008
Last update
Dec 27, 2021

Study contacts

Michelle Williams, Ph.D.
study director · Osiris Therapeutics, Inc.
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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