Adverse Effects of Stem Cell Therapy

After numerous clinical trials and research, scientists have found that stem cell therapy can treat various medical conditions and injuries, thanks to its regenerative properties. However, like any other medical treatment, this treatment may have some side effects.

With the help of this article, we will introduce you to some of the potential risks and side effects of stem cell treatment and mention some points to avoid.

• Potential side effects and complications of stem cell treatments:

Stem cell therapy is an ideal option due to its ability to repair damaged tissues and cells or replace them with new ones. This treatment harnesses the regenerative potential of stem cells, which are capable of differentiating into specific cell types. However, this treatment also carries various risks and concerns. Let’s take a look at it:

• Risk 1 : One of the biggest risks of stem cell therapy is the potential for tumor growth. Stem cells can develop into cancer if they begin to divide excessively or transform into abnormal cells. This applies to embryonic stem cells as well as reprogrammed stem cells, as the risk stems from their ability to develop into any type of cell. Stem cell therapy clinics mostly use mesenchymal stem cells (MSCs) because they are safe and well-tolerated.

• The second risk : Immune rejection is a complication of stem cell treatment. The body may perceive foreign stem cells as a threat and attack them, causing inflammation and damage. This is most likely to occur in hematopoietic stem cells (HSCs), which are stem cells that develop into blood cells.

• Risk 3 : Sometimes, stem cell therapy can lead to infections or other problems that occur with invasive medical treatments. If the stem cells are injected in the wrong place or the needle is inserted incorrectly, it can cause harm. Therefore, it is recommended that this procedure be performed only by trained nurses, under the supervision of a specialist in regenerative medicine.

• Risk 4 : Also, stem cell therapy may not work well with other medications a person is taking, which may cause adverse reactions.

• Fifth risk : Some people fear the ethics of using embryonic stem cells, questioning the right and wrong aspects of stem cell therapy.

• Risk 6 : Some doctors may suggest stem cell treatments that have not been proven effective or properly tested. These treatments can be dangerous and may not work.

Risk 7 : Patients should be aware that stem cell therapy may not always be effective. It is not a sure solution, and it may not always be effective. Stem cell therapy may not last long, so the patient may require further treatment later.

Risk 8 : Stem cell therapy can be very expensive and may not be covered by insurance. This means the patient may have to pay large sums out of pocket.

• The difference between hematopoietic stem cell transplantation and mesenchymal stem cell therapy

The oldest and most popular method of stem cell treatment, called hematopoietic stem cell transplantation (HSCT), has the most risky side.

Hematopoietic stem cells contain large amounts of HLA proteins on their surface. This can cause the recipient’s immune system to mistake the transplanted cells for invaders and attack them.

When a bone marrow transplant is performed from another person (called an allogeneic transplant), the donor’s bone marrow must be a match for the recipient’s bone marrow. During this process, the recipient’s immune system may need to be suppressed to avoid rejection. This can lead to several negative side effects due to the high levels of human leukocyte antigen (HLA) expression in the donor’s stem cells.

Many adverse effects of hematopoietic stem cell transplantation (HSCT) occur because the transplanted cells attack the body’s own cells. This occurs because the transplanted cells perceive the body’s cells as foreign invaders. This occurs in approximately 22% of patients. Sometimes, during treatment for certain conditions, the immune system is significantly weakened, which can lead to infection. Other adverse effects can also occur:

• Refuse the bait.
• Graft failure (when transplanted cells in a person’s body don’t do what they’re supposed to do.)
• Relapse of the disease.

Doctors use hematopoietic stem cell transplants only when the benefits outweigh the potential risks. They use them to treat diseases such as leukemia, other types of blood cancer, and certain blood problems people are born with, such as sickle cell anemia and polycythemia. New treatments are also used for severe cases of multiple sclerosis (MS) and when autoimmune diseases worsen.

The specialized stem cells we use in our clinics have very few human leukocyte antigens (HLA) on their surfaces. They also naturally reduce the amount of HLA on their surfaces over time. This means that mesenchymal stem cells can be safely used in various medical treatments without the need to find a perfect match between donor and recipient. Mesenchymal stem cells are often used to treat many diseases due to their rapid recovery. Researchers and regulatory authorities are constantly concerned about the safety of this treatment.

The U.S. Food and Drug Administration has raised some concerns about the use of mesenchymal stem cells for treatment. These concerns include:

• Reactions at the treatment site.

1. Stem cells move from their location and turn into the wrong type of cell or grow too large.
2. Not working as expected.
3. Tumor growth.

Results of experiments conducted on people with various health conditions show that it is safe to use mesenchymal stem cells as long as the procedures are carefully performed by trained experts and meet standard requirements.

• Is stem cell therapy safe?

There are two types of publications on the safety of mesenchymal stem cell treatments: one is a large review of many other studies to determine their results, and the other is a report of what happened in specific trials. In many trials, the frequency of adverse side effects is investigated in patients receiving mesenchymal stem cell treatment compared to those receiving a placebo or no treatment at all.

Manoj M. Lalu conducted a large study in 2012, and Yang Wang conducted another large study in 2021. They looked at several other studies from 2004 to 2021.

The study, conducted in 2012, included 36 trials on 1,005 patients in 14 countries.

In 2021, there were 62 studies involving more than 3,546 patients, covering more than 20 different health issues.

Effects of stem cell treatment

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

Adverse events at the management site;

1. mild anemia;
2. Fatigue and insomnia.
3. holding
4. transient fever

• Side effects of stem cell therapy

In trials, the highest rate of reactions after receiving mesenchymal stem cell-based drugs was 8%. Here are some of the results.

No significant difference in arrhythmias and other cardiac effects was observed between the MSC-treated group and the untreated group. The highest incidence of arrhythmic effects was 7%.

They found no significant difference in stomach problems between patients who received mesenchymal stem cells and those who did not. However, in one study, they found that 11% of patients had higher bilirubin levels.

Doctors found that one of the patients had phlebitis.

The incidence of lung problems ranged from 0% to 3%, and included mild lung problems, a condition called bronchiolitis obliterans, and significant improvements in lung function.

Rare but serious side effects of mesenchymal stem cell administration, such as metabolic and nutritional problems, infections, death, cardiac arrhythmias, and central nervous system and vascular problems, remained the same regardless of whether patients received the treatment or a placebo.

Mesenchymal stem cell therapy has been shown to be safe in trials for certain diseases.

Safety of stem cell therapy in autoimmune disorders:

In nine studies on systemic sclerosis, involving 133 people, side effects occurred in 16 cases. These side effects were mostly mild and related to the treatment process, such as localized pain, swelling, and redness. These effects improved or disappeared within a week. One person developed a skin infection near his mouth as a result of an injection, but it improved after taking oral antibiotics.

In ten studies involving 231 patients with systemic lupus erythematosus, those treated with mesenchymal stem cells experienced fewer severe side effects than those who received no treatment or a placebo. Both groups developed respiratory infections. In the mesenchymal stem cell-treated group, only one person experienced a drop in white blood cell count, pneumonia, and a subcutaneous abscess. In the non-mesenchymal stem cell-treated group, one person experienced a stroke and abdominal fluid accumulation.

None of the 557 COVID-19 participants in 13 clinical trials who received mesenchymal stem cell therapy reported any major side effects. Many people experienced only mild side effects. Some experienced a mild fever, but it cleared up on its own.

A large study of people with heart problems found that there was no significant difference in adverse side effects between people who received the treatment and those who received a placebo.

Analysis of 12 trials involving 823 participants.

Analysis of six trials involving 625 patients with heart failure.

In addition to a previous analysis of 23 randomized studies involving 1,255 people.

The number of deaths among patients who underwent mesenchymal stem cell transplantation was lower. In one review, out of 1,255 patients, only four events were believed to have been due to the treatment. These events included local bruising, a temporary problem with the heart’s electrical system during the procedure, fluid accumulation around the heart, and fluid in the lungs during the procedure.

Safety of stem cell treatment for neurological disorders

The review examined clinical trials for spinal cord injuries, multiple sclerosis, and ischemic stroke, and included 1,044 patients.

Spinal cord injury has 25 studies.

MS has 14 studies.

Ischemic strokes have 9 studies.

Researchers discovered that a person with a spinal cord injury died after doctors implanted cells directly into their spine. In some cases, 8 out of 100 patients experienced a fever, while others experienced mild headaches. One person suffered seizures due to epilepsy and required hospitalization. Two people developed meningitis after spinal injections, but they recovered quickly.

In seven studies conducted between 2016 and 2022, no serious side effects were observed in MS patients. The research included six trials involving 86 patients, and one study followed patients for 10 years. No major problems associated with pluripotent stem cell therapy were observed. In another four-year study on MS involving 24 patients, some patients experienced mild to moderate symptoms, such as headache, low-grade fever, and back pain. No serious side effects were recorded during the study.

• A study on autism was conducted on 325 people. Researchers found that 16 people experienced minor problems as a result of the study.

1. headache
2. low fever
3. lower back pain
4. nausea and vomiting
5. exhaustion

There have been some concerns about the potential for tumor growth. This may be due to the ability of mesenchymal stem cells to proliferate prolifically and release numerous growth factors. The FDA has also addressed these concerns. Tumor growth increased in animal experiments where some animals developed cancer, or where mesenchymal stem cells were placed in conjunction with cancer cells.

In recent years, there has been much talk about how mesenchymal stem cells can help treat cancer. However, given how they work, this approach can be both good and bad. It’s important to be cautious and conduct extensive research before using them. Tumors tend to grow more rapidly with embryonic stem cells, which come from embryos or materials used in in vitro fertilization. We can’t use these cells much in medicine because people are concerned about their safety.

• Concluding thoughts

Many patients fear that stem cell treatment may cause adverse side effects. Results vary depending on the type of cells and how they are administered. Injections into the eye, heart, or myocardium carry higher risks. Currently, mesenchymal stem cells (MSCs) are the safest, most studied, and most predictable cell-based therapy.

Stem cell therapy can help treat many diseases and injuries, but it can also cause some side effects. It is important for patients to be aware of these risks. Before making a decision, patients should consult their physician about the potential side effects and risks of this treatment.