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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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Recovery Following Partial Medial Meniscectomy

Intervention / Treatment
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* Drug: Chondrogen
* Drug: Chondrogen
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Chondrogen (low dose) | Drug: Chondrogen<br>* Intra-articular injection of ex vivo cultured adult human mesenchymal stem cells<br>|
| Experimental: B<br>Chondrogen (high dose) | Drug: Chondrogen<br>* Intra-articular injection of ex vivo cultured adult human mesenchymal stem cells<br>|
| Placebo Comparator: C<br>Hyaluronan | Drug: Placebo<br>* Intra-articular injection of Hyaluronan<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of treatment adverse event rates |  | Through 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concomitant Medications |  | Through 3 years | 
| Visual Analog Scale |  | Through 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Knee, Meniscus, Meniscectomy, Mesenchymal Stem Cells, MSCs, Adult Human Stem Cells, Osiris, Chondrogen