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

January 7, 2022 updated by: Mesoblast International Sàrl

A Long-Term Follow-up Study of Chondrogen - Adult Human Stem Cells Delivered by Intra-articular Injection Following Meniscectomy in Subjects 18-60 Years

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States
        • University of Southern California Keck School of Medicine
    • Indiana
      • Indianapolis, Indiana, United States
        • OrthoIndy
    • Minnesota
      • Bloomington, Minnesota, United States
        • TRIA Orthopaedic Center
    • Texas
      • San Antonio, Texas, United States
        • Unlimited Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparison of treatment adverse event rates
Time Frame: Through 3 years
Through 3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Concomitant Medications
Time Frame: Through 3 years
Through 3 years
Visual Analog Scale
Time Frame: Through 3 years
Through 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mesoblast International Sàrl

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (ACTUAL)

September 1, 2011

Study Completion (ACTUAL)

September 1, 2011

Study Registration Dates

First Submitted

June 19, 2008

First Submitted That Met QC Criteria

June 19, 2008

First Posted (ESTIMATE)

June 20, 2008

Study Record Updates

Last Update Posted (ACTUAL)

January 11, 2022

Last Update Submitted That Met QC Criteria

January 7, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 551

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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