Written by: Mr. Bubu
Source: Stem Cell Man said
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When exosomes are hot, many institutions like to put any project on exosomes, exosomes have earned enough eyeballs, and they are also vigorously sought after by capital, showing a thriving scene. When we see exosomes thriving, we must also be able to see all kinds of publicity on the market.
Stem cell therapy is one of the most cutting-edge and hottest directions in medical research today. Currently, most stem cell products are in the early stages of research, and their safety and efficacy still need to be tested in clinical trials. Although there are many studies and clinical trials in the field of stem cells, there are not many stem cell therapies or products approved for marketing.
On May 4, 2023, researchers from the Faculty of Pharmacy of the University of Reading and Universiti Sains Malaysia published an article at Stem Cell Research & Therapy describing the current state of the global commercialized stem cell exosomes market in 2023.
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Basic overview of stem cell exosomes
The scientific community generally believes that the beneficial effect of mesenchymal stem cell therapy is paracrine effects. To a large extent, the therapeutic effects of paracrine are attributed to the reduction of inflammatory response, immunomodulation, and activation of endogenous regeneration. All "paracrine effects" are mediated by soluble paracrine factors and extracellular vesicles. It is widely accepted that extracellular vesicles are a common way of communicating between cells. Thus, extracellular vesicles are involved in a variety of biological processes (e.g., immune system regulation, intratissue environment stability, inflammation regulation, and aging).
Extracellular vesicles are divided into three subtypes, microvesicles, exosomes and apoptotic bodies, which differ from each other in biogenesis, release mechanism, size, composition and function. Due to the actual extraction process, fully purified exosomes cannot be obtained. The International Society of Extracellular Vesicles (ISEV) recommends that exosomes and microvesicles are collectively referred to as small extracellular vesicles (sEVs).
Exovesicles three musketeers: apoptosomisomes, microvesicles, exosomes
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Global exosome therapy market research
In 2016, Turner and Knoepfler found that 351 companies in the United States alone directly marketed stem cell therapies. A follow-up study in 2021 showed that 1,480 U.S. businesses operated 2,754 stem cell clinics. The cells sold are mainly mesenchymal stem cells of various tissue sources.
Like stem cells, many companies are developing stem cell exosome therapies and offering exosome therapies directly to consumers. Of course, in science and industry, exosome products are also being used in various indications in clinical trials. As of November 2022, a total of 433 clinical trials have been registered in the US Clinical Trials Registry ClinicalTrials.gov, evaluating the efficacy and safety of exosomes. < for the convenience of interpretation, whether it is secretomes, exosomes, or extracellular vesicles (EVs), the following are collectively referred to as exosomes. >
(1) Global distribution of exosome therapy
114 businesses and clinics claim to provide stem cell exosomes directly. Most are located in the United States (34), followed by Mexico (10), United Arab Emirates (8), Malaysia (7), Germany and India (5 each), Spain, the United Kingdom and Turkey (4 each), Canada, Thailand, Singapore and Iran (3 each), Serbia, Russian Federation, Poland and South Korea (2 each), Ireland, Switzerland, Slovenia, Austria, Ukraine, Guatemala, Costa Rica, Philippines, South Africa, Ecuador and Cyprus (1 each). Among them, the United States, Mexico, the United Arab Emirates and Malaysia together have more than half of the world's exosome clinics.
Global distribution of exosome therapy
(2) The source of exosomes
About the source of exosomes: allogeneic stem cell exosomes (60), autologous cell exosomes (30), and stem cells of unknown origin (21). Regarding tissue origin of exosomes, most exosomes did not disclose cellular origin (38%), followed by blood cell sources (24%), amniotic fluid sources (10%), adipose tissue sources (9%), bone marrow sources (9%), hair papillae (1%), and umbilical cord sources (7%). Surprisingly, there are also plant stem cell exosomes (2%).
Exosome origin
(3) Types of exosomes to treat diseases
Skincare, anti-aging and hair loss are the most common indications. The most marketable type of intervention is skin care. The most common type of intervention was, of course, skin care (48), followed by anti-aging (42), hair loss (36), autism (32), arthritis and Parkinson's disease (30). In addition, other indications include diabetes (26), Lyme disease (9), chronic diseases (6), neuropathy (2), rare immune system diseases (1), new coronary pneumonia (1) and Alzheimer's disease (1).
Types of diseases treated by exosomes
(4) Market price of exosome therapy
Exosome treatment charges range from $99~$20,000. The lowest price is skin care and the highest price is arthritis.
Generally, skincare charges are lower, around $100. There are also claims that exosomes can treat Parkinson's disease, autism or diabetes, but the fees are higher, ranging from about 1310-20000 US dollars. Of course, Medicare can pay for all of this.
Fee range for exosome therapy
(5) Publicity of exosome therapy
Information on exosome therapy:
- Most companies can provide weak scientific evidence for exosome therapy (general science popularization and medical qualifications of medical staff)
- Most companies (more than 70%) can provide medical qualifications, exosome technology descriptions, and operational technical descriptions of medical personnel.
- Only about 20% and 30% of companies cite clinical trials and peer-reviewed scientific papers, respectively, and the scientific evidence is slightly higher.
- A small percentage (<5%) mentioned celebrities, borrowing celebrity effect propaganda and not scientific evidence.
Publicity of exosome therapy
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Exosome therapy market access dilemma
Exosome treatments on the market are currently unproven therapies, and efficacy and safety data are insufficient. The marketing of exosome therapy is mainly carried out online, and it is often carried out in institutions without medical qualifications. Most exosomes are administered intravenously. Studies show that the majority (>30%) of companies that directly provide exosome therapy are located in the United States.
The dilemma and challenges of exosome marketization:
(1) Lack of standardized preparation methods (exosome heterogeneity, resulting in differences in treatment effects) (2) Limited understanding of the mechanism of action (knowing the reason for it, efficacy evaluation to be solved) (3) Regulatory challenges (international regulatory gaps, heavy work and a long way) (4) Large-scale preparation (long preparation time, high cost, and difficulty in clinical-grade products) In the United States, exosome therapy is approved and regulated by the US FDA. On December 6, 2019, FDA issued a public safety notice regarding exosome products. In general, exosomes used to treat disease are regulated as drugs and biological products under the Public Health Service Act and the Federal Food, Drug and Cosmetic Act, and are subject to premarket review and approval requirements. In the EU, exosomal therapy is regulated by the European Medicines Agency (EMA); In the UK, exosome therapy is regulated by the UK Medicines and Healthcare Products Regulatory Agency (MHRA). In the European Union, stem cell exosomes are administered as advanced therapeutic products (ATMPs). Therefore, the number of companies engaged in the direct sale of exosome therapies in the US, EU and UK is shockingly high under their own regulations!
Exosome knowledge popularization:
Professor Cheng Ke: When exosome therapy meets stem cell therapy and rides on the rise of stem cells - the rise of hot "exosomes", how to view the role of exosomes in skin damage repair The "exosomes" you don't know: there are good and bad industry giants targeting, what are the hottest research and development directions of exosomes at present? Conclusion: Exosomes are a good thing, but without rigorous scientific research and effective supervision, it is difficult to exert their clinical value. At present, there is no regulatory approval for exosome drugs in any country in the world. When we see exosomes thriving, we must also be able to see all kinds of publicity on the market. The United States is the hardest hit area for the application of stem cell exosomes, please don't just laugh at China!
Further reading: https://doi.org/10.1186/s13287-023-03335-2
Nature · Review: The Role of T Cells in Aging
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