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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00702741
First Posted: June 20, 2008
Last Update Posted: December 4, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mesoblast, Ltd. ( Mesoblast International Sàrl )
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 Mesoblast, Ltd. ( Mesoblast International Sàrl ):

Primary Outcome Measures:
  • Comparison of treatment adverse event rates [ Time Frame: Through 3 years ]

Secondary Outcome Measures:
  • Concomitant Medications [ Time Frame: Through 3 years ]
  • Visual Analog Scale [ Time Frame: Through 3 years ]

Enrollment: 55
Study Start Date: June 2008
Study Completion Date: September 2011
Primary Completion Date: September 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Mesoblast International Sàrl
  More Information

Responsible Party: Mesoblast International Sàrl
ClinicalTrials.gov Identifier: NCT00702741     History of Changes
Other Study ID Numbers: 551
First Submitted: June 19, 2008
First Posted: June 20, 2008
Last Update Posted: December 4, 2014
Last Verified: December 2014

Keywords provided by Mesoblast, Ltd. ( Mesoblast International Sàrl ):
Knee
Meniscus
Meniscectomy
Mesenchymal Stem Cells
MSCs
Adult Human Stem Cells
Osiris
Chondrogen