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

Sponsor

Mesoblast International Sàrl (Industry)

Overall Status

Completed

CT.gov ID

NCT00702741

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

13.8

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Recovery Following Partial Medial Meniscectomy	Drug: Chondrogen Drug: Chondrogen Drug: Placebo	Phase 1/Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

55 participants

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

Study Start Date :

Jun 1, 2008

Actual Primary Completion Date :

Sep 1, 2011

Actual Study Completion Date :

Sep 1, 2011

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Comparison of treatment adverse event rates [Through 3 years]

Secondary Outcome Measures

Concomitant Medications [Through 3 years]
Visual Analog Scale [Through 3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country
1	University of Southern California Keck School of Medicine	Los Angeles	California	United States
2	OrthoIndy	Indianapolis	Indiana	United States
3	TRIA Orthopaedic Center	Bloomington	Minnesota	United States
4	Unlimited Research	San Antonio	Texas	United States