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
  Purpose

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 Intervention Phase
Recovery Following Partial Medial Meniscectomy
Drug: Mesenchymal Stem Cells
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Further study details as provided by Osiris Therapeutics:

Primary Outcome Measures:
  • meniscal volume
  • adverse events

Secondary Outcome Measures:
  • quality of life
  • immunological endpoints

Estimated Enrollment: 60
Study Start Date: September 2005
Estimated Study Completion Date: February 2008
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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00225095

Locations
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
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
Investigators
Study Director: Michelle Williams, Ph.D. Osiris Therapeutics, Inc.
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00225095     History of Changes
Other Study ID Numbers: Osiris 550
Study First Received: September 21, 2005
Last Updated: January 26, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Osiris Therapeutics:
meniscectomy
Chondrogen
Mesenchymal Stem Cells
Osiris

ClinicalTrials.gov processed this record on July 20, 2014