Title: A phase I/II, randomized, controlled, double-blind, study of chondrogen—adult universal cell delivered by intra-articular injection following meniscectomy in patients 18–60 years
ClinicalTrials.gov Identifier: NCT00225095
Sponsor: Mesoblast International Sàrl
Purpose: The purpose of this study is to determine whether chondrogen is a safe and effective postoperative treatment of the knee following meniscectomy (the surgical removal of all or part of a torn meniscus)
Primary outcome measures: Meniscal volume
Secondary outcome measures: Quality of life; immunological endpoints; safety
Status: Completed
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
ClinicalTrials.gov Identifier: NCT00702741
Sponsor: Mesoblast International Sàrl
Purpose: 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)
Primary outcome measures: Comparison of treatment adverse event rates
Secondary outcome measures: Concomitant medications; visual analog scale
Status: Completed
Title: Phase 2 study to assess safety and tolerability of a single injection into the knee joint of two different doses of MSB-CAR001 combined with hyaluronan compared to hyaluronan alone in patients who have undergone an ACL reconstruction
ClinicalTrials.gov Identifier: NCT01088191
Sponsor: Mesoblast, Ltd.
Purpose: The purpose of this study is to evaluate safety and preliminary efficacy of MSB-CAR001 in subjects who have recently undergone an anterior cruciate ligament reconstruction
Primary outcome measures: To determine the overall safety of stem cell injections (MSB-CAR001) plus carrier using physical examinations, vital signs, treatment-emergent adverse events, and results of clinical lab tests (hematology, serum chemistry, inflammation, and immunology)
Secondary outcome measures: To evaluate the overall efficacy with MSB-CAR001 plus hyaluronan compared to hyaluronan alone using MRI scans and X-ray of the involved knee joint and access the change in outcomes (KOOS, SF-36) and pain (VAS)
Status: This study is ongoing, but not recruiting participants
PTA serves as an attractive target for the development of novel therapeutic approaches such as the use of stem and progenitor cells. Interestingly, a majority of the preclinical work in the field of osteoarthritis has utilized animal models that are more representative of PTA as compared to primary OA [5]. In this regard, novel therapies may arise from a better understanding of molecular mechanisms involved in the development of PTA after joint injury, combined with a better understanding of the intra-articular action of stem cells. Increasing evidence suggests that the regenerative capabilities of stem cells may be through their influence on the inflammatory environment [28, 29]. Given the emerging body of evidence that stem cell therapies lessen the development of PTA after a wide range of joint injuries, it is likely that human clinical trials will be initiated to assess the ability of stem cell therapies to improve outcomes in carefully selected patient populations.
Acknowledgments
Supported in part by the Arthritis Foundation, the Department of Defense, the Collaborative Research Center, AO Foundation, Davos Switzerland, and NIH grants AR48182, AR48852, AG15768, AR50245, and AG46927.
References
1.
Anderson DD, Chubinskaya S, Guilak F, Martin JA, Oegema TR, Olson SA, Buckwalter JA. Post-traumatic osteoarthritis: improved understanding and opportunities for early intervention. J Orthop Res. 2011;29(6):802–9.PubMedCentralPubMedCrossRef
2.
3.
Frobell RB, Roos HP, Roos EM, Roemer FW, Ranstam J, Lohmander LS. Treatment for acute anterior cruciate ligament tear: five year outcome of randomised trial. BMJ. 2013;346:f232.PubMedCentralPubMedCrossRef
4.
Marsh JL, Buckwalter J, Gelberman R, Dirschl D, Olson S, Brown T, Llinias A. Articular fractures: does an anatomic reduction really change the result? J Bone Joint Surg Am. 2002;84-A(7):1259–71.PubMed
5.
6.
Evans CH, Kraus VB, Setton LA. Progress in intra-articular therapy. Nat Rev Rheumatol. 2014;10(1):11–22.PubMedCentralPubMedCrossRef
7.
Diekman BO, Guilak F. Stem cell-based therapies for osteoarthritis: challenges and opportunities. Curr Opin Rheumatol. 2013;25(1):119–26.PubMedCentralPubMedCrossRef
8.
9.
Iyer SS, Rojas M. Anti-inflammatory effects of mesenchymal stem cells: novel concept for future therapies. Expert Opin Biol Ther. 2008;8(5):569–81.PubMedCrossRef
Related posts:
Arthritis That Develops After Joint Injury: Is It Post-Traumatic Arthritis or Post-Traumatic Osteoarthritis?
Post-Traumatic Arthritis: Definitions and Burden of Disease
Potential Mechanisms of PTA: Cell Death
Closed Joint ACL Disruption Murine Model of PTA
Biomarkers of PTA
Instability: Dynamic Loading Models
Stay updated, free articles. Join our Telegram channel
Full access? Get Clinical Tree
