Trends in clinical trials for articular cartilage repair by cell therapy

Тенденции клинических исследований клеточной терапии для восстановления суставного хряща
Takaharu Negoro, Yuri Takagaki, Hanayuki Okura, Akifumi Matsuyama
2018-10-05

articular cartilage repairautologous chondrocyte implantationcartilage regenerationcell therapyclinical trials
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.
1
Analysis of 203 ClinicalTrials.gov studies characterized global clinical research trends in cell-based articular cartilage regeneration.
2
Cartilage-derived cell studies included many phase III trials, whereas fewer bone-marrow and adipose-cell studies reached phase III.
3
Cell sources shifted chronologically from cartilage- and bone-marrow-derived cells toward adipose-tissue-derived cells.
4
ClinicalTrials.gov enables chronological, perspective-level analysis of global translational trends despite not providing comprehensive trial results.
5
Limited progression of bone-marrow- and adipose-derived cell therapies to phase III suggests that many developments from these sources have not yet succeeded.
6
One product required more than 100 months to progress from phase I initiation through phase III completion.

Clinical trials of cell therapy products for articular cartilage repair and regeneration

Global clinical translational trends, including cell-source shifts, trial-phase progression, and development timelines

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2018-10-05
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Takaharu Negoro
Yuri Takagaki
Hanayuki Okura
Akifumi Matsuyama
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