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Adult human mesenchymal stem cells delivered via intra-articular injection to the knee following partial medial meniscectomy: a randomized, double-blind, controlled study.
J Bone Joint Surg Am. 2014 Jan 15; 96(2):90-8.JB

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.

Authors+Show Affiliations

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.OrthoIndy, 5255 East Stop 11 Road, Suite 300, Indianapolis, IN 46237.TRIA Orthopaedic Center, 8100 Northland Drive, Bloomington, MN 55431.Triangle Orthopaedic Associates, PA, 120 William Penn Plaza, Durham, NC 27704.Osiris Therapeutics, Inc., 7015 Albert Einstein Drive, Columbia, MD 21046.Osiris Therapeutics, Inc., 7015 Albert Einstein Drive, Columbia, MD 21046.

Pub Type(s)

Clinical Trial, Phase I
Clinical Trial, Phase II
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24430407

Citation

Vangsness, C Thomas, et al. "Adult Human Mesenchymal Stem Cells Delivered Via Intra-articular Injection to the Knee Following Partial Medial Meniscectomy: a Randomized, Double-blind, Controlled Study." The Journal of Bone and Joint Surgery. American Volume, vol. 96, no. 2, 2014, pp. 90-8.
Vangsness CT, Farr J, Boyd J, et al. Adult human mesenchymal stem cells delivered via intra-articular injection to the knee following partial medial meniscectomy: a randomized, double-blind, controlled study. J Bone Joint Surg Am. 2014;96(2):90-8.
Vangsness, C. T., Farr, J., Boyd, J., Dellaero, D. T., Mills, C. R., & LeRoux-Williams, M. (2014). Adult human mesenchymal stem cells delivered via intra-articular injection to the knee following partial medial meniscectomy: a randomized, double-blind, controlled study. The Journal of Bone and Joint Surgery. American Volume, 96(2), 90-8. https://doi.org/10.2106/JBJS.M.00058
Vangsness CT, et al. Adult Human Mesenchymal Stem Cells Delivered Via Intra-articular Injection to the Knee Following Partial Medial Meniscectomy: a Randomized, Double-blind, Controlled Study. J Bone Joint Surg Am. 2014 Jan 15;96(2):90-8. PubMed PMID: 24430407.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Adult human mesenchymal stem cells delivered via intra-articular injection to the knee following partial medial meniscectomy: a randomized, double-blind, controlled study. AU - Vangsness,C Thomas,Jr AU - Farr,Jack,2nd AU - Boyd,Joel, AU - Dellaero,David T, AU - Mills,C Randal, AU - LeRoux-Williams,Michelle, PY - 2014/1/17/entrez PY - 2014/1/17/pubmed PY - 2014/3/13/medline SP - 90 EP - 8 JF - The Journal of bone and joint surgery. American volume JO - J Bone Joint Surg Am VL - 96 IS - 2 N2 - 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. SN - 1535-1386 UR - https://wwww.unboundmedicine.com/medline/citation/24430407/Adult_human_mesenchymal_stem_cells_delivered_via_intra_articular_injection_to_the_knee_following_partial_medial_meniscectomy:_a_randomized_double_blind_controlled_study_ L2 - http://dx.doi.org/10.2106/JBJS.M.00058 DB - PRIME DP - Unbound Medicine ER -