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

Completed · Phase 1/Phase 2

Conditions studied: Recovery Following Partial Medial Meniscectomy

In brief

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).

Key facts

Study ID

NCT00225095

Run by

Mesoblast International Sàrl

People needed

60

Starts

2005-09-01

Expected to finish

2008-04-01

Last updated by the study team

2021-12-27

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Southern California — Los Angeles, California, United States
• Orthopedic Center of Vero Beach — Vero Beach, Florida, United States
• Midwest Orthopaedics at Rush — Chicago, Illinois, United States
• Ortholndy — Indianapolis, Indiana, United States
• Greater Chesapeake Associates — Baltimore, Maryland, United States
• TRIA Orthopaedic Center — Bloomington, Minnesota, United States
• Triangle Orthopaedics Associates, P.A. — Durham, North Carolina, United States
• Unlimited Research — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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