Follow-up Study of Chondrogen® Delivered by Intra-Articular Injection Following Meniscectomy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Osiris Therapeutics.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Osiris Therapeutics
ClinicalTrials.gov Identifier:
NCT00702741
First received: June 19, 2008
Last updated: August 24, 2010
Last verified: August 2010
  Purpose

The objective of the present study is to establish the long-term safety of an intra-articular injection of human mesenchymal stem cells (hMSCs) (Chondrogen).


Condition Intervention Phase
Recovery Following Partial Medial Meniscectomy
Drug: Chondrogen
Drug: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Long-Term Follow-up Study of Chondrogen - Adult Human Stem Cells Delivered by Intra-articular Injection Following Meniscectomy in Subjects 18-60 Years

Further study details as provided by Osiris Therapeutics:

Primary Outcome Measures:
  • Comparison of treatment adverse event rates [ Time Frame: Through 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Concomitant Medications [ Time Frame: Through 3 years ] [ Designated as safety issue: No ]
  • Visual Analog Scale [ Time Frame: Through 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: June 2008
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Chondrogen (low dose)
Drug: Chondrogen
Intra-articular injection of ex vivo cultured adult human mesenchymal stem cells
Experimental: B
Chondrogen (high dose)
Drug: Chondrogen
Intra-articular injection of ex vivo cultured adult human mesenchymal stem cells
Placebo Comparator: C
Hyaluronan
Drug: Placebo
Intra-articular injection of Hyaluronan

Detailed Description:

The long-term safety of human mesenchymal stem cells (hMSCs) (Chondrogen) has not yet been established. This 3-year follow-up study will provide additional data to gain understanding of the safety of the investigational agent. This study is designed to determine the safety of a single intra-articular injection of 50 million donor-derived hMSCs or 150 million donor-derived hMSCs in suspension with commercial sodium hyaluronan compared to an injection of vehicle (diluted hyaluronan) alone. The injections were performed under the initial study, Protocol No. 550.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject must have received an injection in Protocol No. 550
  • Subject must have completed the 6-month and final 2-year visit in Protocol No. 550
  • Subject must provide written informed consent for entry into the extension study
  • Subject must provide authorization for use and disclosure of protected health information for entry into the extension study
  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: NCT00702741

Locations
United States, California
University of Southern California Keck School of Medicine
Los Angeles, California, United States
United States, Indiana
OrthoIndy
Indianapolis, Indiana, United States
United States, Minnesota
TRIA Orthopaedic Center
Bloomington, Minnesota, United States
United States, Texas
Unlimited Research
San Antonio, Texas, United States
Sponsors and Collaborators
Osiris Therapeutics
  More Information

No publications provided

Responsible Party: Sharron McCulloch, Osiris Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00702741     History of Changes
Other Study ID Numbers: 551
Study First Received: June 19, 2008
Last Updated: August 24, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Osiris Therapeutics:
Knee
Meniscus
Meniscectomy
Mesenchymal Stem Cells
MSCs
Adult Human Stem Cells
Osiris
Chondrogen

ClinicalTrials.gov processed this record on September 16, 2014