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Scientific Articles   |    
Adult Human Mesenchymal Stem Cells Delivered via Intra-Articular Injection to the Knee Following Partial Medial MeniscectomyA Randomized, Double-Blind, Controlled Study
C. Thomas Vangsness, Jr., MD1; Jack Farr, II, MD2; Joel Boyd, MD3; David T. Dellaero, MD4; C. Randal Mills, PhD5; Michelle LeRoux-Williams, PhD5
1 University of Southern California Orthopaedic Surgery Associates, Keck School of Medicine, 1520 San Pablo Street, Suite 2000, Los Angeles, CA 90033. E-mail address: vangsness@usc.edu
2 OrthoIndy, 5255 East Stop 11 Road, Suite 300, Indianapolis, IN 46237
3 TRIA Orthopaedic Center, 8100 Northland Drive, Bloomington, MN 55431
4 Triangle Orthopaedic Associates, PA, 120 William Penn Plaza, Durham, NC 27704
5 Osiris Therapeutics, Inc., 7015 Albert Einstein Drive, Columbia, MD 21046
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  • Disclosure statement for author(s): PDF

A commentary by Henry B. Ellis, MD, is linked to the online version of this article at jbjs.org.

Investigation performed at the University of Southern California Orthopaedic Surgery Associates, Keck School of Medicine, Los Angeles, California, Unlimited Research, San Antonio, Texas, Triangle Orthopaedic Associates, Durham, North Carolina, Orthopaedic Center of Vero Beach, Vero Beach, Florida, OrthoIndy, Indianapolis, Indiana, TRIA Orthopaedic Center, Bloomington Minnesota, and Greater Chesapeake Orthopaedic Associates, Baltimore, Maryland



Disclosure: One or more of the authors received payments or services, either directly or indirectly (i.e., via his or her institution), from a third party in support of an aspect of this work. None of the authors, or their institution(s), have had any financial relationship, in the thirty-six months prior to submission of this work, with any entity in the biomedical arena that could be perceived to influence or have the potential to influence what is written in this work. Also, no author has had any other relationships, or has engaged in any other activities, that could be perceived to influence or have the potential to influence what is written in this work. The complete Disclosures of Potential Conflicts of Interest submitted by authors are always provided with the online version of the article.

Copyright © 2014 by The Journal of Bone and Joint Surgery, Inc.
J Bone Joint Surg Am, 2014 Jan 15;96(2):90-98. doi: 10.2106/JBJS.M.00058
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Abstract

Background: 

There are limited treatment options for tissue restoration and the prevention of degenerative changes in the knee. Stem cells have been a focus of intense preclinical research into tissue regeneration but limited clinical investigation. In a randomized, double-blind, controlled study, the safety of the intra-articular injection of human mesenchymal stem cells into the knee, the ability of mesenchymal stem cells to promote meniscus regeneration following partial meniscectomy, and the effects of mesenchymal stem cells on osteoarthritic changes in the knee were investigated.

Methods: 

A total of fifty-five patients at seven institutions underwent a partial medial meniscectomy. A single superolateral knee injection was given within seven to ten days after the meniscectomy. Patients were randomized to one of three treatment groups: Group A, in which patients received an injection of 50 × 106 allogeneic mesenchymal stem cells; Group B, 150 × 106 allogeneic mesenchymal stem cells; and the control group, a sodium hyaluronate (hyaluronic acid/hyaluronan) vehicle control. Patients were followed to evaluate safety, meniscus regeneration, the overall condition of the knee joint, and clinical outcomes at intervals through two years. Evaluations included sequential magnetic resonance imaging (MRI).

Results: 

No ectopic tissue formation or clinically important safety issues were identified. There was significantly increased meniscal volume (defined a priori as a 15% threshold) determined by quantitative MRI in 24% of patients in Group A and 6% in Group B at twelve months post meniscectomy (p = 0.022). No patients in the control group met the 15% threshold for increased meniscal volume. Patients with osteoarthritic changes who received mesenchymal stem cells experienced a significant reduction in pain compared with those who received the control, on the basis of visual analog scale assessments.

Conclusions: 

There was evidence of meniscus regeneration and improvement in knee pain following treatment with allogeneic human mesenchymal stem cells. These results support the study of human mesenchymal stem cells for the apparent knee-tissue regeneration and protective effects.

Level of Evidence: 

Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Peer Review 

This article was reviewed by the Editor-in-Chief and one Deputy Editor, and it underwent blinded review by two or more outside experts. It was also reviewed by an expert in methodology and statistics. The Deputy Editor reviewed each revision of the article, and it underwent a final review by the Editor-in-Chief prior to publication. Final corrections and clarifications occurred during one or more exchanges between the author(s) and copyeditors.

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    References

    Accreditation Statement
    These activities have been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of the American Academy of Orthopaedic Surgeons and The Journal of Bone and Joint Surgery, Inc. The American Academy of Orthopaedic Surgeons is accredited by the ACCME to provide continuing medical education for physicians.
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