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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2011-09-30

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).

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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.

Conditions

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Recovery Following Partial Medial Meniscectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

Chondrogen (low dose)

Group Type EXPERIMENTAL

Chondrogen

Intervention Type DRUG

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

B

Chondrogen (high dose)

Group Type EXPERIMENTAL

Chondrogen

Intervention Type DRUG

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

C

Hyaluronan

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Intra-articular injection of Hyaluronan

Interventions

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Chondrogen

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

Intervention Type DRUG

Chondrogen

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

Intervention Type DRUG

Placebo

Intra-articular injection of Hyaluronan

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No