Cell therapy for severe COVID-19 patients: clinical trials and cost-effectiveness

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Cell therapy for severe COVID-19 patients: clinical trials and cost-effectiveness

Cell therapy for severe COVID-19 patients: clinical trials and cost-effectiveness.  The race between countries and companies to develop effective vaccines and therapies against COVID-19 is proceeding rapidly, and many trials are ongoing.

Among them, cell-based therapies mainly target the moderate to severe stages of COVID-19, and have achieved gratifying results. Mesenchymal stem cells (MSCs) are due to their promotion/anti-inflammatory and immune regulation behaviors, natural killer cells (NK) are due to their ability to dissolve virus-infected cells and regulate the resulting immune response, and dendritic cells are due to immunotherapy and Cell-based vaccine engineering.

SARS-CoV2-specific T cells stimulate and promote the immune system, as well as mesenchymal stem cell-derived exosomes due to cell-free therapy and beneficial manufacturing aspects, which bring the application of cell therapy for the treatment of COVID-19 and similar virus infections. Great hope.

In addition, recently, an innovative method for COVID-19 based on engineered human mesenchymal stem cells has been launched. During the antigen recognition process, the human immune system will continue to evacuate and degrade.

However, the economic conditions of the government and the country, as well as the cost of treatment drugs, affect the clinical methods of managing and exiting this pandemic. This summary describes the cost-effective aspects of cell-based clinical trials and cell therapy.

In this regard, limited clinical studies have been reported; at the same time, several clinical trials have been approved to start its second and third phase trials for the treatment of patients with COVID-19 acute respiratory distress syndrome.

Regarding the cost of cell therapy, many people believe that the high cost of cell-based therapy will drop significantly. Therefore, it is hoped that cell therapy will soon be approved for the treatment of viral diseases such as COVID-19.

The concept of cell therapy makes the field of regenerative medicine develop in the direction of natural physiological processes. Currently, several cell-based therapies are undergoing clinical trials to obtain approved treatments for COVID-19. So far, stem cells, natural killer (NK), dendritic cells (DN) and exosomes are the main drug candidates for the treatment of COVID-19. As shown in Figure 1, cell-based products are used as potential therapeutic strategies for the prevention and treatment of COVID-19 patients.

The individual’s monocyte-DCs are pulsed with SARS-CoV-2 (the causative virus of COVID-19) peptide, and then used to cultivate T cells from the same individual to generate SARS-CoV-2 specific immune cells. These lymphocytes can be cryopreserved or injected into vulnerable individuals as a prevention or treatment for COVID-19.

In addition, an innovative method based on engineered human mesenchymal stem cells has recently been introduced. During the antigen recognition process, the body’s immune system will continue to evacuate and degrade COVID-19. Chinese researchers claim that the antibody response of this vaccine is effective and rapid. This method opens up a new perspective for the research of COVID-19 vaccine.

Recently, various types of cell therapy (CBT) have been introduced. However, despite the massive increase in the demand for CBT, especially stem cell therapies, these methods are still quite expensive. For example, the cost of a simple combined injection is about US$1,000, and depending on the condition, the cost of advanced treatment may be as high as US$100,000. Although according to the US Centers for Disease Control and Prevention’s plan, through approved drugs and supportive therapies, the mild to moderate stages of COVID-19 are manageable, even if advanced technology therapies such as cell therapy are used here, they may There are still many worries about COVID-19 severely ill patients.

Figure 1 A schematic diagram of DC and monocyte therapy that can be used for COVID-19 treatment.

Generally speaking, cell-based therapies can be divided into two categories, including autologous and allogeneic. Both of these two groups can be used in clinical applications with minimal manipulation. One of the main challenges of autologous cell therapy is that it cannot make full use of the target scale and cost-effectiveness to provide a complete treatment process; the preparation of autologous cell therapy drugs is very manual and labor-intensive, requiring too many production workers and long The culture time and contamination increase the risk of failure of treatment based on autologous cells.

The production process of allogeneic cell therapy is similar to that of other biological agents. Existing scalable technologies can be used to increase and expand its sources, and store them through cryopreservation for future applications. Therefore, allogeneic cell therapy is used to produce a larger cell volume at a lower treatment cost. However, cell stability requires a long shelf life, which may be an obstacle. The traditional biological preparation process has an average of 15 unit operations.

According to the cost of each patient, labor and materials are allocated as the highest cost, as well as other parameters. The cell preparation medium components must be provided in accordance with GMP-level guidelines. After one use, the remaining content is invalid. Therefore, cell therapy is expensive in clinical applications. However, there are several suggestions that when cell therapy becomes the mainstream treatment method, its cost can be drastically reduced.

Among cell-based treatments, there are more clinical trials registered for mesenchymal stem cell therapy, and there are more opportunities to approve the treatment of COVID-19 and even other similar viral infections. MSCs (Figure 2a) and iPSC are at the forefront of stem cell-based research and treatment.

In this regard, bone marrow mesenchymal stem cells have some advantages, such as inherent clinical characteristics, sufficient clinical basic research, and unique capabilities. The ability to obtain sources and store as a cell bank. Due to the storage capacity, allogeneic bone marrow mesenchymal stem cells are often used in clinical applications (Figure 2b); however, the clinical application of these cells and other cell-based methods require new prototypes and Labor ability to show the best clinical results. Therefore, we see that most cell-based clinical trials are conducted in wealthy and developed countries (Figure 2c).

Figure 2 Summary report of cell-based COVID-19 treatment clinical trials

In cell-based therapy, MSCs have migration and homing capabilities, immunomodulatory functions, anti-inflammatory effects and multi-lineage differentiation potential. These characteristics make these cells the first choice for stem cell therapy. In addition, the potential benefits of MSC in the treatment of COVID-19, especially in ARDS patients, support the rapid start of clinical trials. Together with the bidding application of MSC (Figure 3), these have obtained safety documents from FDA-approved clinical trials. . We know that MSC treatment does not have any adverse side effects on patients.

Several clinical studies have published the results of MSC treatment in patients with ARDS, its safety and/or no serious adverse events (Table 1). Case reports on MSC treatment of severe COVID-19 patients indicate that MSC transplantation provides COVID-19 treatment. Valuable clinical data may be an alternative method for the treatment of COVID-19, especially in ARDS patients. MSCs can play a role in the treatment of COVID-19 in two important ways, including immune regulation and differentiation potential. Therefore, a literature review shows that treatment based on mesenchymal stem cells can significantly reduce the cytokine storm in patients with severe COVID-19.

Figure 3 Overview of the treatment process of mesenchymal stem cells for COVID-19 patients (1: source and extraction, 2: minimal laboratory operation, 3: patient intravenous drip).

Table 1 List of published clinical studies on COVID-19 treatment based on mesenchymal stem cells

A study showed that drugs for the treatment of COVID-19 can be produced at the lowest price, from US$1 to US$29 per course of treatment. They reported that as the main drug for the treatment of COVID-19[24], the lowest estimated production cost of remdesivir may be US$0.93 per day, favibivir is US$1.45 per day, hydroxychloroquine is US$0.08 per day, and chloroquine is US$0.08 per day. $0.02 per day.

Despite this, the current prices of these drugs are significantly higher than the stated costs, especially in the United States. Of course, different countries and companies are independent in this regard; in fact, countries and people, especially low-income and middle-income countries, must consider the economic aspects of medicine and choose the most effective and economical treatment.

The topics discussed in this article can be summarized into two propositions, including cell therapy for COVID-19 patients and the cost of these treatments. In recent months, more than 80 cell-based clinical trials for the treatment of COVID-19 have been initiated. This shows that this field is one of the current and future medical development trends. So far, MSCs and their derived exosomes, NK cells and DN cells are the main drug candidates for the treatment of COVID-19.

However, cost efficiency is one of the main parameters of clinical services, and currently, cell-based therapies are considered expensive drugs. However, there are some suggestions and agreements to reduce costs. The cell tissue bank plays a significant role in reducing the cost of cell therapy and is the basic way to promote the clinical application of cell therapy. In short, it is necessary to promote safe and accessible COVID-19 treatment for low-income/middle-income countries.

(source:internet, reference only)

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