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Completed

NCT Number: NCT00702741

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

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).

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Key information

Conditions

Recovery Following Partial Medial Meniscectomy

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Southern California Keck School of Medicine, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chondrogen

Drug

Intra-articular injection of ex vivo cultured adult human mesenchymal stem cells

Placebo

Drug

Intra-articular injection of Hyaluronan

Primary outcomes

  1. Comparison of treatment adverse event rates

    Time frame: Through 3 years

Secondary outcomes

  1. Concomitant Medications

    Time frame: Through 3 years

  2. Visual Analog Scale

    Time frame: Through 3 years

Sponsors and collaborators

Lead sponsor

Mesoblast International Sàrl

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jun 20, 2008
Registry last updated
Jan 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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