StemCell Therapy

Researchers atAirlangga University (Unair) and the State Intelligence Agency (BIN) released on June 12what appeared to be an encouraging statement:the discovery of five combination drug therapies and two stem cell therapies for treating COVID-19.

The acute respiratory disease caused by the SARS-CoV-2 virus has claimed at least 2,000 lives in Indonesia to date.

The joint statementattributed to Unair andBIN also said that themedicines were ready for distributionin treating COVID-19 patients.

Drug combinations

The five combination therapiesfor COVID-19 are: lopinavir/ritonavir with azithromycin, lopinavir/ritonavir with doxycycline, lopinavir/ritonavir with clarithromycin, hydroxychloroquine with azithromycin, and hydroxychloroquine with doxycycline.

In addition, the statementclaimed that the researchers had identified two types of isolated stemcells that inhibitedSARS-CoV-2 activity:hematopoietic stem cells (HSCs) and natural killer (NK) cells.

Their goodwill to bring an end tothe pandemic should be appreciated. Unfortunately, their conclusions seem premature and could lead to more damaging consequences for the public.

In theory, the drug combinationsrecommended by Unair and BIN have the potentialto inhibit SARS-CoV-2. Lopinavir and ritonavir are protease inhibitors that are currently used to treat people with HIV/AIDS. Hydroxychloroquine is a malarial treatment, while azithromycin, doxycyclineand clarithromycin are antibiotics that can fight secondary bacterial (not viral) infections in COVID-19 patients who have developed pneumonia.

However, theory does not necessarily work inpractice. Noneof these drugs have been provenin any clinical study to bea safe and effective treatmentfor COVID-19. The World Health Organization (WHO) has started clinical trials involving thousands of patients in dozens of countries to test the efficacy and safety of these drugs. So far, there has been no clear indication that these drugs, whether individually or in combination,are effective in treating COVID-19.

In fact, evidence exists that hydroxychloroquine may worsen the condition of patients, which led the WHO to suspend the clinical trial of the drug.

Unair and BIN are correct in conducting in vitro (test tube) experiments to verify the effect and toxicity of the drugs for SARS-CoV-2. Unfortunately, they have not communicated in any clear way on how they designed, executedand analyzed their experiments.

We do not know how they cultured the virus, what kind of negative controls they used, what kind of cells they testedor whether the cells they usedcontained the necessary receptors for SARS-CoV-2 to enter a human cell. More importantly, it is crucial to note thatthe results of in vitro experiments(however encouraging) cannot be assumed to be safe and effectivetreatments for direct use in human patients. For example, the United States Food and Drug Administration (FDA) on averageapprovedless than 10 percent of drugs that performed well in vitroas safe for humanprescription.

The human lungs contain millions of cells comprising dozens of different types that perform intricate interactions. The proposed drugs can also affect other organs in the human body and cause adverse reactions.

Instead of announcing that these five combination therapiesare ready for treating COVID-19, Unair and BIN should first run arandomizedcontrolled trial (RCT) to confirm their findings.Recruiting diverse patient populations is also critical to ensuring thefairness and robustness of the study.

Despite their good intentions, all the drugs that Unair and BIN researchers have proposedare strong medicines, whether individually or in combination, that can potentially cause unwanted sideeffects and even death. Surely none of us want to rush into an unproven treatmentin order to avoid developing even more overwhelming health problems in the future.

Stem cell therapy

Stem cell therapy is another COVID-19treatment that Unair and BIN researchers have proposed. Stem cells are undifferentiated cells thathas the potential to develop into many different types of cells in human body. One type of stem cell they have proposed is hematopoietic stem cells (HSCs), whichdevelop into blood cells, includingimmune cells that help the body fight pathogens and infections.

However, stem cell therapy is still considered very risky, expensiveand limited to treating a few cancers, such as leukemia. No evidence exists that stem cell therapy is efficient in treating viral infections in the human bodysuch asCOVID-19.

As with the drug therapies, the Unair and BIN researchers did not say how they performed their stem cell experiment. We have no information oncrucial aspects likestem cell culturing protocol, the stem cell's differentiation status, tumorigenic potential, proliferation capacity orexcretion patterns, and how they tested stem cell activity against SARS-CoV-2.

Even if the researchersestablished a sound experimentalprotocol for their in vitro experiments, administering stem cell therapy to COVID-19 patients is an extremely dangerous procedure that can result in undesirable costs, such as malignancy, the stem cells attacking other healthy cellsand possibly death.

Injecting stem cells into the human body carries a huge risk of immuno-rejection (think of a blood type A patient receivinga bloodtype B infusion, but witha much more severe reaction). The doctors administering the treatment must isolate autologousstem cells from the individual patient or allogenic stem cells froma separate donor, culture them, and reinject the treated cells into the patient. These processes are extremely laborious, time-consumingand expensive, and there is no clear indication that the treatment will produce a safe and successful outcome against viral infection.

This is hardly a sound strategy to use during a pandemic. Furthermore, thecommon procedureis to administer powerful immunosuppressants to reduce the strength of thepatients immune system, particularly in the allogenic scenario, which would minimizethe risk of immuno-rejection. However, it would be unwise to shut down a COVID-19patient's immune system that is neededto work properly for their body to fight SARS-CoV-2.

Unair and BIN's valiant effortsshould still be applauded, as they are committed to treating COVID-19 and ending the pandemic. The public is waiting impatiently for the health crisis to subside so they canresume their normal lives.

However, everyone should realize that discovering treatments and developing a potential vaccine for a disease that was virtually unknown six months ago takes a lot of time and resources.

Unair and BIN said that they had submitted their research to at least seven peer-reviewed internationaljournals, but this does not mean that their research is validated immediately. It still needs reviewing and questioned by their scientific peers.

It is necessary for the researchers to publish their findings onan open access, preprint repository for biological or medical research papers like BiorXiv or MedrXiv, so that scientists and people around the worldcan scrutinize and engage in healthy scientific discourse.

We absolutely deserve good news during the pandemicon safe medical treatmentsand vaccines. We also deserve complete, clear and transparent public communications from all COVID-19 stakeholders, including researchers and governments, to ensure that all actions are evidence-based, safeand effective.

The writer is a research scientist with a PhD in biochemistryfrom the University of Cambridge, which he earned as a recipient of the 2015-2019 Gates Cambridge Scholarship program.

Disclaimer: The opinions expressed in this article are those of the author and do not reflect the official stance of The Jakarta Post.

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This entry was posted on June 17, 2020 at 11:44 am and is filed under Death by Stem Cells. You can follow any responses to this entry through the RSS 2.0 feed. Both comments and pings are currently closed. |