Safety and Adverse Effects of Stem Cell Therapy: A Comprehensive Overview

For many patients, deciding in favor of stem cell therapy can be a daunting task. It’s understandable, given that it’s a burgeoning field of medicine that has yet to receive FDA approval.

Rather than obscuring or overhyping these treatments, this article aims to address safety concerns and potential side effects candidly and directly.

The Main Risks of Stem Cell Treatments and Stem Cell Safety

The Food and Drug Administration (FDA) emphasized the primary concerns about the risks of MSC treatment:

• Immune rejection
• Possibility of stimulating tumor growth
• Site reactions
• Overdose or failure to function as intended

Let us take a closer look at them and see in which cases patients may experience adverse reactions of stem cell therapy.

Is It Possible That My Body Rejects Stem Cells? 

Stem cell effectiveness and safety depends on the types of stem cells used. The confusion surrounding stem-cell treatments has led to the widespread misconception that stem-cell therapy is dangerous. 

The most common side effects are associated with hematopoietic stem cell therapy (HSCT), or stem cell transplantation.

HSCs are a type of stem cell found in the bone marrow that can give rise to all types of blood cells in the body. They are crucial for the production of red blood cells, white blood cells, and platelets. Because of this, HSCT has been employed in the treatment of diseases relating to the blood and bone marrow, such as leukemia, autoimmune diseases, and specific genetic disorders.

However, HSCs have a high expression of the human leukocyte antigens (HLA) on their surface. HLAs are proteins that help the immune system distinguish between its own cells and foreign substances.

This means that when HSCs from a donor are transplanted into a recipient during a hematopoietic stem cell transplant (HSCT), they begin to attack the patient’s cells. 

To avoid negative outcomes, it is necessary to match the HLA of the donor and recipient as closely as possible. In addition, patients often receive medicines that lower their immune system’s activity.

Why It Won’t Happen To You at Swiss Medica

Swiss Medica does not perform hematopoietic stem cell transplants. Instead, we use mesenchymal stem cells (MSCs). 

Mesenchymal stem cells have a low expression of HLA, making them less likely to trigger an immune response and eliminating the need for donor matching. 

MSCs, along with other types of stem cells, have several mechanisms that minimize rejection:

• Low major histocompatibility complex (MHC) molecules expression: This makes cells less recognizable as foreign.
• Immunomodulatory effects: They can suppress the immune system, further reducing rejection.
• Targeted migration: They move to inflamed areas, where they can exert therapeutic effects.

Stem cells from certain sources, like umbilical cords, have even stronger immunomodulatory properties. 

MSCs also have a high potential for tissue regeneration and differentiation, which can help treat a variety of diseases.

 However, safety remains a top priority for researchers and regulators.

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Can Stem Cells Trigger Cancer?

A big concern with stem cell therapy is the chance of tumors forming. This risk mainly comes from certain types of stem cells that can divide too much or change into abnormal cells, like embryonic or fetal stem cells.

At Swiss Medica, we only use mesenchymal stem cells because they’re safer and people’s bodies handle them well. Multiple clinical trials demonstrated that no malignancies occurred after application of MSCs. 

Furthermore, studies have demonstrated that MSCs may also inhibit tumor growth in certain cases, such as breast cancer, Kaposi’s sarcoma, hepatoma, and melanoma models.

When MSCs and tumor cells mix, it causes more white blood cells to go to the area, like monocytes, granulocytes, and T-lymphocytes. This increase in immune cells allows them to communicate with nearby tissues. The immune cells and inflamed tissues produce certain chemicals that attract more active lymphocytes, which help boost the body’s ability to fight cancer. However, this method seems to have both benefits and risks and requires cautious and precise implementation.

The mixed findings about how mesenchymal stem cells affect tumor growth could be due to experimental factors, like where the cells come from, the route of cell administration, and the type of tumor studied. Some studies on animals showed tumor growth, but these animals either had cancer already or had cancer cells injected at the same time as the MSCs. 

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How High Is the Risk of a Potential Infection?

One of the concerns with stem cell effectiveness and safety is the risk of contracting hepatitis, HIV, and other viruses and bacteria from donor cells. To mitigate this risk, it is necessary to:

• Screen the donor’s materials.
• Check the cells before preparation in the laboratory.
• Ensure a safe and clean environment in the laboratory.
• Monitor and examine cells during cultivation and prior to injection.

Swiss Medica achieved this by following all necessary processes to prevent contamination and maintaining a sterile environment in its laboratory, where cells are created and cultured throughout all testing and sampling. 

• Our laboratory and equipment meet international Grade A cleanliness standards. 
• Our donors undergo thorough medical screenings to confirm their health status and the absence of infections.
• Before use, our stem cells go through rigorous testing to ensure purity, viability, and sterility. This includes checks for bacterial, fungal, and viral contamination, as well as genetic testing to verify their identity and function.

With all of these requirements met, there is no risk of contamination. Since 2011, we have not had any infection complications at Swiss Medica.

Can I Have an Overdose?

Stem cell safety is confirmed by clinical trials. MSCs, which we use at Swiss Medica, possess immunomodulatory properties, meaning they can lower inflammation and hinder immune reactions that might cause tissue harm or rejection. 

However, it’s crucial to note that excessive doses can be harmful. Potential risks include:

• Vascular overload,
• Blood clots, 
• Lung retention, leading to respiratory issues. 

To prioritize safety, we tailor the dosage for each patient individually, never surpassing the maximum safe limit. 

If It’s Safe, Why Wouldn’t the FDA Approve MSC Transplants?

The FDA has approved several stem cell-based products. Thanks to the 21st Century Cures Act, the FDA established clear guidelines for which stem-cell treatments it oversees in 2017. This includes bone marrow transplantation to treat certain cancers as well as blood and immune system disorders.

Secondly, the journey from stem cell science to medicine is long and costly. While rigorous FDA evaluation is crucial for safety and efficacy, some clinics have undermined genuine research by offering unproven therapies, diverting patients from legitimate studies. These clinics argue that FDA regulations, which require costly toxicology and animal studies, are excessively burdensome and force them down an impractical and unethical drug development path.

As you can see, it’s a work in progress.

What Are Real Side Effects of Stem Cells?

Possible side effects of the treatment include the following:

• Short-term fever
• Headaches
• Malaise
• Aches and pains in muscles
• Nausea
• Vomiting is possible in children

All of them happen quite rarely in our experience. The majority of these symptoms last only a few hours following the injection. Pain relievers or rest after the surgery may help alleviate the discomfort.

How Does Swiss Medica Prevent Side Effects Risks?

1. By conducting thorough preparation and investigation into the patient’s history. We conclude detailed consultations, along with surveys and tests, to ensure that stem cell therapy is effective for each patient. We may advise against receiving stem cell therapy because of certain conditions.

2. By ensuring the safety of stem cell products. Our stem cells, sourced from umbilical cords and placentas, are carefully collected in a sterile environment to prevent contamination. These tissues, typically discarded after birth, are ethically harvested without invasive procedures and closely monitored and checked for each stage until successful administration.

3. By having our laboratory located in the same facility as the clinic. Our on-site cell laboratory‌, with facilities for flow cytometry and cryopreservation for long-term storage of patients’ stem cells, allows us to handle the entire stem cell therapy process in-house.

It also ensures tight quality control and coordination throughout the stem cell therapy process. The specialist staff can closely monitor and optimize each step, providing a high level of care and stem cell safety for the patient.

4. By hiring only highly skilled professionals who are extensively trained in stem cell therapy procedures and adhere to strict protocols to minimize any potential risks, including infections. They possess the expertise necessary to calculate precise dosages of stem cell products and execute treatments with care.

What Scientific Studies Have To Say about Stem Cells’ Safety

To ensure transparency, we will provide a thorough overview of the official information derived from scientific studies, confirming stem cell safety, along with links for readers interested in delving deeper into the topic.

Safety of stem cell therapy is studied through wide-ranging analyses and specific trial reports. These studies often compare the number of side effects in patients who receive MSC treatment to those who receive a fake treatment or no treatment at all.

What Are the Most Frequent Side Effects?

Two big analyses, one in 2012 by Manoj M. Lalu and another in 2021 by Yang Wang, looked at research from 2004 to 2021. The 2012 study reviewed 36 trials with 1005 patients in 14 countries, while the 2021 study included 62 trials with 3546 patients covering over 20 health conditions.

Common Side Effects:

• Temporary fever
• Mild anemia
• Site reactions
• Constipation
• Fatigue
• Sleep disturbances

Some uncommon but serious adverse effects of stem cell therapy like metabolism issues, infections, death, heart rhythm problems, and disorders of the nervous system and blood vessels were not affected by MSC treatment. There wasn’t a big difference in how often these side effects happened between patients who got MSC treatment and those who got a placebo.

Since most of the side effects seen in stem cell treatments are mild, it confirms safety of stem cell therapy.

With our vast experience at Swiss Medica, we’ve come across similar side effects. Rather than simply sending patients away after treatment, we provide support and assistance if any adverse effects occur post-therapy. This sets us apart from many clinics offering similar treatments.

Other interesting findings from the studies:

• Overall, the most common reactions experienced during treatment were reported by 8% of the people.

• There wasn’t much difference in heart issues between those who got MSC treatment and those who didn’t.
• Gastrointestinal problems didn’t show a big difference between MSC-treated and non-treated patients. Only one study found bilirubin elevation in 11% of patients. Bilirubin is a yellowish pigment produced during the breakdown of red blood cells. Normally, it is processed by the liver and excreted from the body through bile.
• The rate of lung issues ranged from 3% to 13%, including mild problems like trouble breathing and more severe conditions like bronchiolitis obliterans, as well as significant improvements in lung function.

What About MSC Treatment Safety in Disease-Specific Trials?

Trials focusing on specific diseases also confirmed that MSC treatment is safe.

Important Note: This information is for general knowledge and should not be taken as medical advice. Please consult with a healthcare professional for personalized recommendations regarding MSC treatment.

Autoimmune Conditions: Systemic Sclerosis

In 9 clinical trials involving 133 participants with systemic sclerosis, most reported side effects were mild and related to the procedure: 

• local pain,
• swelling, 
• redness, which usually improves within a week,
• one case had a moderate reaction (skin infection), but no severe adverse effects were reported.

Infectious Issues: COVID-19 

In 13 clinical studies of COVID-19 involving 557 patients, no severe adverse effects related to MSCs were reported. Rare, non-severe effects included mild fever, which resolved on its own.

Cardiovascular Conditions: Heart failure

In studies involving a large number of patients with heart failure (823-1255), researchers didn’t find a significant difference in severe side effects between those who received MSC treatment and those who received a placebo.

However, the rate of death was noticeably lower among patients who received MSC treatment. In one review, out of 1255 patients, only four adverse events were suspected to be related to the treatment:

• local hematoma,
• temporary bundle branch block (the bundle branches are part of the electrical conduction system of the heart),
• pericardial effusion (it refers to the accumulation of fluid in the pericardial sac that surrounds the heart and helps protect it), 
• pulmonary edema  (fluid buildup in the lungs while a medical procedure is being performed) during the procedure.

Neurological Conditions

There was a big review of studies about neurological conditions, involving a total of 1044 patients. 

Spinal cord injury 

The majority had mild issues like fever and headaches. Some severe effects included:

• one case of seizures needing hospital care;
• two cases of meningitis after injections into the spine.
  

But these problems got better quickly. One patient died after getting cells implanted directly into the cord.

Multiple sclerosis

Seven trials from 2016 to 2022 didn’t report any serious side effects from MSC treatment. Another review covering six trials with 86 patients, including one study that followed patients for 10 years, also didn’t find any serious issues related to MSC treatment.

Autism 

With 325 patients, there were 16 minor side effects like low fever, headaches, and fatigue.

Swiss Medica Research Study

Mesenchymal Stem Cell Infusions for Children with ASD

Read Research

Conclusion: Stem Cell Therapy is Safe With Treatment Protocols

As studies have shown, most side effects were either absent or mild, once again proving safety and efficacy of stem cell therapy. 

However, to ensure stem cell injections safety, it’s important for doctors to understand the risks associated with them. They can then create strong safety plans and keep a close eye on patients to make sure everything goes smoothly.

Swiss Medica’s medical staff addresses these challenges by staying current with research, adhering to strict safety protocols, and communicating openly with patients. Here, we maximize the incredible potential of regenerative medicine while keeping patients safe and healthy.  

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Make informed decisions about your health. Swiss Medica is committed to providing you with the safest treatment options available. Fill out the form to schedule a free consultation and receive personalized guidance.

Dr. Aleksandra Fetyukhina, MD

Medical Advisor, Swiss Medica doctor

Your Name Please fill out this field Phone Please fill out this field E-mail Please fill out this field

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