Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
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 Associates - Baltimore, MD
Information provided by:
Osiris Therapeutics
ClinicalTrials.gov Identifier:
NCT00225095
First received: September 21, 2005
Last updated: January 26, 2010
Last verified: March 2009

September 21, 2005
January 26, 2010
September 2005
Not Provided
  • meniscal volume
  • adverse events
Same as current
Complete list of historical versions of study NCT00225095 on ClinicalTrials.gov Archive Site
  • quality of life
  • immunological endpoints
Same as current
Not Provided
Not Provided
 
A Phase I/II Study of Chondrogen Delivered by Intra-Articular Injection Following Meniscectomy
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

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).

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Recovery Following Partial Medial Meniscectomy
Drug: Mesenchymal Stem Cells
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
February 2008
Not Provided

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00225095
Osiris 550
Not Provided
Not Provided
Osiris Therapeutics
  • 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 Associates - Baltimore, MD
Study Director: Michelle Williams, Ph.D. Osiris Therapeutics, Inc.
Osiris Therapeutics
March 2009

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