Clinical trial NCT00225095: A Phase I/II Study of Chondrogen Delivered by Intra-Articular Injection Following Meniscectomy
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Recovery Following Partial Medial Meniscectomy
Keywords: meniscectomy
Chondrogen
Mesenchymal Stem Cells
Osiris
Lead sponsor: Mesoblast, Ltd.
Sponsor class: INDUSTRY
Collaborators: name: University of Southern California
name: Midwest Orthopedics at Rush - Chicago, IL
name: Unlimited Research - San Antonio, TX
name: Triangle Orthopaedic Associates, P.A.
name: Orthopedic Center of Vero Beach - Vero Beach, FL
name: OrthoIndy
name: TRIA Orthopaedic Center
name: Greater Chesapeake Orthopaedic Associates, LLC
First posted: 2005-09-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Meniscal Volume
timeFrame: 6 months
Secondary outcomes:
measure: Quality of Life Questionnaire
timeFrame: 2 years
measure: Visual Analog Scale (VAS)
timeFrame: Baseline to 2 years
measure: Lysholm Knee Scale
timeFrame: 2 years
measure: Safety Assessment Adverse Event
timeFrame: 2 years
measure: Safety Assessment Immunological
timeFrame: 2 years
measure: Safety Assessment Laboratory
timeFrame: 2 years
measure: Safety Assessment Physical Exam
timeFrame: 2 years
measure: Safety Assessment Magnetic Resonance Imaging (MRI)
timeFrame: 2 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Vero Beach
country: United States
facility: Orthopedic Center of Vero Beach
state: Florida
city: Chicago
country: United States
facility: Midwest Orthopaedics at Rush
state: Illinois
city: Indianapolis
country: United States
facility: Ortholndy
state: Indiana
city: Baltimore
country: United States
facility: Greater Chesapeake Associates
state: Maryland
city: Bloomington
country: United States
facility: TRIA Orthopaedic Center
state: Minnesota
city: Durham
country: United States
facility: Triangle Orthopaedics Associates, P.A.
state: North Carolina
city: San Antonio
country: United States
facility: Unlimited Research
state: Texas
Study officials:
affiliation: Osiris Therapeutics, Inc.
name: Michelle Williams, Ph.D.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.