As exosomes become recognized for their benefits as cell-free therapeutics, exosome clinical trials are increasing in number. Exosomes are small vesicles ranging from 30-100nm in size that are found in nearly all eukaryotic fluids and facilitate a range of important cellular functions. They transfer DNA, RNA, and proteins to other cells, altering the function of target cells.
Exosome Clinical Trials
In addition to increasing in number, exosome clinical trials are tightly concentrated within specific regions of the world.
There are now 92 trials listed on ClinicalTrials.gov that contain the term “exosome” or “exosomes.”
Interestingly, the bulk of these exosome clinical trials are occurring within the United States (32 of 92 trials or 35%). Although trends in Canada often follow the U.S., the exosome market is an exception with only one trial underway in Canada at this time.
The next most active region for exosome clinical trial activity is Europe (30 trials) and then East Asia (15 trials).
A table of these exosome clinical trials is presented below.
| Region Name | Number of Studies | |
|---|---|---|
| World | 92 | |
| Africa [map] | 2 | |
| East Asia [map] | 15 | |
| Japan | 2 | [studies] |
| Europe [map] | 30 | |
| Middle East [map] | 2 | |
| North America | 33 | |
| Canada [map] | 1 | [studies] |
| United States [map] | 32 | [studies] |
| South Asia [map] | 1 | |
Exosome Therapeutics
Exosomes are valuable, because they reduce many of the risks associated with traditional cell therapies. It has been long known that stem cells have the potential to exert therapeutic effects, but it has only recently been recognized that exosomes play an important role how they may exert their effects.
To solidify the clinical trial data that is being collected, it will be necessary to further clarify the mechanisms for the healing function of the exosomes. It will also be important to maximize production of exosomes, as well as identify the optimal dose and time course and route of administration.
Ideally, exosome clinical trials will experience geographic distribution over time, with clinical trial activity spreading to new continents. For now, two-thirds (67%) of exosome trials remain concentrated in the U.S. and Europe, with East Asia claiming an additional 16%.
To learn more, view the “Market for Stem Cell Exosomes.”
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