Abstract

Focal and degenerative lesions of articular cartilage greatly reduce the patient’s quality of life. Various therapies including surgical treatment have been developed, but a definitive therapy is not yet known. Several cell therapy products have already been developed and are available in the market. In this study, we examined the clinical research trends related to cell therapy products in the cartilage repair field based on data obtained from the ClinicalTrial.gov website. Although this website does not provide comprehensive results of clinical trials, it offers information on prospective clinical trials, including work in progress, and thus allows for chronological analysis of the data. We selected 203 studies related to the field of cartilage regeneration from ClinicalTrial.gov. The results showed a shift in the clinical translational trend in utilized cells from cartilage- and bone marrow- to adipose tissue-based cells. Whereas the studies that used cartilage as the cell source included many phase III trials, fewer studies using bone marrow and adipose tissue cells progressed to phase III, suggesting that most clinical developments using the latter sources have not been successful so far. One product covered the entire period from the start of phase I to the completion of phase III, with a time to completion of more than 100 months. Translational trends in autologous chondrocyte implantation were also discussed. The use of ClinicalTrials.gov as the sole data source can yield a perspective view of the global clinical translational trends, which has been difficult to observe up to this point.

Highlights

  • ClinicalTrials.gov[1] is the clinical trial registration database of the United States, which provides information on the implementation status of more than 260 000 clinical trials from over 200 countries and is the world’s largest clinical trial registration site

  • In this article, focusing on cell therapy products for cartilage repair, which require manufacturing and marketing approval by national authorities, based on the data obtained from ClinicalTrials.gov, we aimed to grasp a big picture of the global translational trend, which has far been difficult to decipher

  • There are already two interesting studies that provided comprehensive analysis relevant to regenerative medicine based on data from ClinicalTrials.gov

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Summary

Introduction

ClinicalTrials.gov[1] is the clinical trial registration database of the United States, which provides information on the implementation status of more than 260 000 clinical trials from over 200 countries and is the world’s largest clinical trial registration site. There are already several early cell therapy commercial products on the market in the United States, Europe, Korea, and Japan.[2,3,4,5,6,7] Several excellent reviews have been published of products developed in this field so far.[8,9,10,11,12,13,14,15] to the best of our knowledge, there are no scientific reports that have comprehensively analyzed and examined the clinical research trends on cell therapy for articular cartilage regeneration based on the ClinicalTrials.gov data registry. In this article, focusing on cell therapy products for cartilage repair, which require manufacturing and marketing approval by national authorities, based on the data obtained from ClinicalTrials.gov, we aimed to grasp a big picture of the global translational trend, which has far been difficult to decipher

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