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After several clinical trials and research, Scientists find that stem cell therapy can treat different medical conditions and injuries because it uses the regenerative ability of stem cells. This therapy can also show some side effects like any other medical treatment.

With the help of this article, we will confront you with some possible risks and side effects of stem cell treatment and mention to you some points to avoid them.

Potential Side Effects and Complications of Stem Cell Treatments

Stem cell therapy is the best treatment option due to its ability to restore or replace damaged tissues and cells with the new ones. This therapy harnesses the regenerative potential of stem cells that can differentiate into different special types of cells. But, this therapy also has various risks and concerns. Let’s check it out:

Risk 1: One of the biggest risks of stem cell therapy is that it can cause tumors to develop. Stem cells might turn into cancer if they start dividing too much or change into abnormal cells. This is true for embryonic or fetal stem cells, and also for reprogrammed stem cells, because the risk is due to their ability to become any type of cell. Stem cell treatment clinics mostly use mesenchymal stem cells (MSCs) because they are safe and well-tolerated.

Risk 2: Immune rejection is another complication of stem cell therapy. The body might see foreign stem cells as a danger and attack them, causing inflammation and damage. This is more likely to happen in hematopoietic stem cells (HSCs), which are stem cells that turn into blood cells.

Risk 3: Sometimes, stem cell therapy can lead to infections or other problems that happen with invasive medical treatments. If stem cells are injected in the wrong spot or the needle isn’t put in right, it can cause harm. That’s why only trained nurses with a specialist in regenerative medicine overseeing them should do this procedure.

Risk 4: Also, stem cell therapy might not work well with other medicines someone takes, which could cause bad reactions.

Risk 5: Some people worry about the ethics of using stem cells from embryos. They think about what’s right and wrong when it comes to stem cell therapy.

Risk 6: Some doctors might offer treatments using stem cells that haven’t been proven to work or tested properly. These treatments could be dangerous and might not even help.

Risk 7: Patients need to know that stem cell treatment might not always work. It’s not a sure fix, and sometimes, it might not work. Sometimes, stem cell therapy might not last a long time, so the patient might need more treatment later on.

Risk 8: Stem cell therapy might cost a lot, and insurance might not pay for it. This means the patient might have to pay a lot of money themselves.

Difference Between Hematopoietic Stem Cell Transplantation and Mesenchymal Stem Cell Therapy

The oldest and most well-known way of treating stem cells, called hematopoietic stem cell transplantation (HSCT), has the most serious side.

Hematopoietic stem cells have lots of HLA proteins on their surface. This can make the recipient’s immune system think the transplanted cells are invaders, so it fights against them.

When someone gets a bone marrow transplant from someone else (called an allogenic transplant), the donor’s bone marrow needs to match the recipient’s. During this process, the recipient’s immune system may need to be suppressed to avoid rejection. This can lead to many negative side effects because of the high levels of HLA expression on the donor’s stem cells.

Many of the bad effects of HSCT happen because the transplanted cells attack the body’s own cells. This happens because the transplanted cells see the body’s cells as foreign. It happens in about 22% of all patients.Sometimes, when treating certain conditions, the immune system is weakened a lot, which can lead to infections. Other bad effects can happen too.

  • graft rejection.
  • Graft failure (when the cells that are transplanted into someone’s body don’t do what they’re supposed to do.)
  • relapse of the disease.

Doctors only use HSCT when the good things it can do are more than the bad things it might cause. They use it for diseases like leukemia, other blood cancers, and certain blood problems people are born with, like sickle-cell anemia and spherocytosis. New treatments are being used for very bad cases of multiple sclerosis (MS) and when autoimmune diseases get really bad.

The special stem cells we use in our clinics have very few HLAs on their surface. They also naturally decrease the amount of HLAs on their surface over time. This means that the MSCs could be used safely for various medical treatments without needing to find a perfect match between the donor and the recipient. MSCs are often used to treat many diseases because they can heal quickly. Investigators and regulators always pay attention to the safety of this treatment.

The FDA mentioned some worries about using MSCs for treatment. They include:

  • Reactions at the treatment site.
  • Stem cells moving from where they’re put and turning into the wrong type of cells or growing too much.
  • Not working as hoped.
  • Tumor growth.

The outcomes of trials on people with various health issues show that it’s safe to use MSCs as long as the procedures are done carefully by trained experts and meet the standard requirements.

Is Stem Cell Therapy Safe?

There are two types of publications about the safety of treatments using mesenchymal stem cells: one is a big study that looks at lots of other studies to see what they found, and the other is reports about what happened in specific trials. In many experiments, they check how often bad side effects happen in patients who get MSC treatment compared to those who get fake treatment or no treatment at all.

Manoj M. Lalu did a big study in 2012, and Yang Wang did another big study in 2021. They looked at lots of other studies from 2004 to 2021.

  • The 2012 study had 36 tests with 1,005 patients in 14 countries.
  • In 2021, there were 62 studies with over 3,546 patients, covering more than 20 different health problems.

Impacts of Stem Cell Treatment

The most common side effects that happen often with stem cell therapy are as follows:.

  • Administration site adverse events;
  • Mild anemia;
  • Fatigue and sleeplessness.
  • Constipation;
  • Transient fever;

Side Effects From the Stem Cell Therapy Process

In trials, the highest rate of reactions after receiving MSC-based drugs was 8%. Here are some of the findings.

  • There wasn’t much difference in heart rhythm problems and other heart effects between the group treated with MSCs and the group that didn’t get treatment. The highest rate of non-rhythmic effects was 7%.
  • They didn’t find a big difference in stomach issues between patients who got MSCs and those who didn’t. But in one study, they found that 11% of patients had higher bilirubin levels.
  • The doctors found that one patient had phlebitis.
  • The number of lung problems varied from none to 3% – 13%. These included mild lung issues, a condition called bronchiolitis obliterans, and good improvement in lung function.

The rare, serious side effects of MSC administration, like problems with metabolism and nutrition, infections, death, irregular heartbeats, and issues with the central nervous system and blood vessels, stayed the same regardless of whether patients got the treatment or a placebo.

MSC treatment was shown to be safe in trials specific to certain diseases.

Stem Cell Therapy’s Safety in Autoimmune Disorders

In 9 studies about systemic sclerosis involving 133 people, there were side effects in 16 cases. These side effects were mostly mild and connected to the treatment process, like local pain, swelling, and redness. They got better or went away within a week. One person had a skin infection near their mouth from an injection, but it got better after taking antibiotics by mouth.

In 10 studies involving 231 patients with systemic lupus erythematosus, those who received treatment with MSCs experienced fewer severe side effects compared to those who didn’t receive any treatment or were given a placebo.Both groups had respiratory infections. In the group treated with MSCs, only one person got low white blood cell count, pneumonia, and an abscess under the skin. In the group not treated with MSCs, one person had a stroke and fluid buildup in the abdomen.

None of the 557 COVID-19 participants in 13 clinical trials who received MSC therapy reported any significant adverse effects. Not many people had mild side effects. Some had a slight fever, but it went away on its own.

A big study with lots of people who have heart problems found that there wasn’t any big difference in bad side effects between the people who got treatment and those who got fake treatment.

  1. An analysis of 12 trials including 823 participants..
  2. The analysis of six trials including 625 heart failure patients.
  3. As well as a previous analysis of 23 randomized studies including 1,255 people.

Patients who got MSCs had fewer deaths. In one review, out of 1,255 patients, only four events were thought to be because of the treatment. These events included a local bruise, a temporary problem with the heart’s electrical system during the procedure, fluid around the heart, and fluid in the lungs during the procedure.

The Safety of Stem Cell Treatment for Neurological Disorders

The review looked at clinical trials for spinal cord injury, multiple sclerosis (MS), and ischemic stroke. It included 1,044 patients.

  • Spinal cord injury has 25 studies.
  • MS has 14 studie.
  • Ischemic strokes has 9 studies.

Researchers found out that one person with a spinal cord injury died after doctors put cells straight into their spine. In some situations, 8 out of 100 patients had a fever, and others had a slight headache. One person had seizures because of epilepsy and needed to go to the hospital. Two people got meningitis after getting injections in their spine, but they got better quickly.

In 7 studies from 2016 to 2022, no serious bad effects were found in people with multiple sclerosis. The research looked at 6 trials with 86 patients and one study that followed patients for 10 years. They didn’t find any big problems linked to MSC treatment. In a study about multiple sclerosis (MS) that lasted for 4 years and involved 24 MS patients, some patients experienced mild and moderate symptoms like headaches, slight fevers, and backaches. There were no serious side effects reported during the study.

A study about autism looked at 325 people. They found 16 people had minor problems because of the study.

  • Headache
  • Low fever
  • Lumbar pain
  • Nausea and vomiting
  • Fatigue

Some worries were about tumors possibly growing. This could be because MSCs can reproduce a lot and release many growth substances. The FDA talked about these things too. The tumor grew more in animal tests where some animals got cancer or where MSCs were put in at the same time as cancer cells.

In the last few years, people are talking a lot about how MSCs could help treat cancer. However, because of how MSCs work, this method can be both good and bad. It’s important to be careful and do a lot of research before using it. Tumors tend to grow more often with embryonic stem cells, which come from embryos or materials used in test-tube fertilization. We can’t use these cells much in medicine because people worry about whether it’s right to use them.

Concluding Thoughts 

Many patients worry that stem cell treatment might cause bad side effects. The outcomes vary depending on the type of cells and how the treatment is done. Injections into the eye, heart, or heart muscle have higher risks. Right now, MSCs are the safest, most studied, and easiest to predict in cell-based therapy.

Stem cell therapy can help treat many illnesses and injuries, but it might also have some bad effects. It’s important for patients to know about these risks. Before deciding, people should talk with their doctor about the good and bad things that could happen with this treatment.

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