Frequently Asked Questions About Safety and Guarantees

Dozens of clinical trials conducted by researchers in more than a dozen nations have demonstrated the safety of using mesenchymal stem cell (MSC) therapy. Thus, we can be certain that stem cells will not in any way harm the patient.

We are sure both of the general safety of stem cells and of the safety of MSC obtained from umbilical cord blood and placentas, which we use in our clinic:

Safety of stem cells in general. MSCs have immunomodulatory properties, which means they can reduce inflammation and inhibit immune reactions that could lead to tissue damage or rejection. They also typically lack MHC Class II molecules, making them less likely to trigger an immune response.

It’s important to notice that although stem cell therapy is considered safe, an overdose can prove quite harmful: the possible consequences include vascular overload, blood clots, and retention in the lungs, which may result in respiratory failure. That is why, for safety reasons, we determine the dose for every patient individually, never exceeding the maximum safe dose.

Safety of the product that we use. MSCs derived from umbilical cords and placentas are harvested in a sterile environment, ensuring there is no risk of contamination. These tissues are usually discarded after childbirth, making the harvesting process ethically straightforward and non-invasive. Before donating the cells, the donors undergo a complete medical examination to ensure their health, lack of infections, and possible aggravating factors.

Before being used in treatments, MSCs undergo a series of rigorous tests to ensure their purity, viability, and sterility. This includes checks for bacterial, fungal, and viral contamination, as well as genetic and vitality testing to confirm their identity and function.

You can learn more about the safety of stem cells in our article.

Here’s how this process typically works:

Cell expansion: Stem cells are initially obtained from a donor or patient. These cells are then cultured and expanded in a controlled environment. This involves providing the cells with appropriate growth factors, nutrients, and conditions to encourage them to multiply.

Cell viability: Throughout the expansion process, the viability of the cells is monitored. Viability assessments determine the percentage of live, functional cells in the culture. Techniques like trypan blue exclusion or flow cytometry can help determine cell viability.

Cell counting: Regular cell counting is performed to track the number of cells as they multiply. Various methods, such as automated cell counters or manual hemocytometers, can be used to count cells accurately.

Proliferation rate: Monitoring the proliferation rate helps determine how quickly the cells are dividing. Adjusting growth conditions can control the rate of expansion to achieve the desired cell quantity.

Quality control: The cells are assessed for quality, which includes characteristics like surface markers, genetic stability, and differentiation potential. Quality control ensures that the cells maintain their therapeutic potential.

Safety control: Numerous tests are performed to check cells for sterility and possible infections, including HIV, hepatitis B, C, herpes, CMV, toxoplasma, mycoplasma, and endotoxins.

Storage and injection: Once tested, the cells are cryopreserved in liquid nitrogen until they are needed. Cells are then administered into the patient’s body in the sterile conditions of the clinic. Since we have our own laboratory in the clinic, there are no concerns regarding transportation.

There is a lot of conflicting information about the safety and effectiveness of stem cells, which generates many myths. Additionally, the doctors adhere to the current guidelines, which do not yet include recommendations for the use of stem cells.

If you wish to speak with a specialist in regenerative medicine, we offer a free online consultation option. During this consultation, we do not sell stem cell therapy; in fact, we sometimes have to decline the applications for therapy due to contraindications or the low potential efficacy of the therapy in a particular case. But we go into extensive explanations about how stem cell therapy works, what research backs it up, and whether it can prove beneficial in your particular case.

Immediate reactions to the treatment may include fever, headache, chills, or a rash. There can also be localized swelling or redness at the site of the injection. All of these are mostly solved with painkillers or having a rest after the procedure, and disappear within 24 hours.

There are no long-term side effects to stem cell therapy.

While stem cell therapy is generally well-tolerated and associated with no serious side effects, there are certain contraindications to consider.

Several possible contraindications include: active oncology, acute infections, prior negative experiences with cell-based treatments, age, body weight, and mental disorders.

However, we assess each case individually. In a consultation, we look at each patient’s medical history and individual suitability for the therapy to ensure optimal safety and efficacy.

The risk of cancer is an important point to consider. However, such a risk is only present when using embryonic or fetal stem cells.

At our clinic, we exclusively use mesenchymal stem cells (MSCs) for therapy. These stem cells are derived from adult tissues and not from fetuses or embryos. Consequently, MSCs do not possess the capacity for uncontrolled differentiation and tumor formation. Extensive research has demonstrated the safety profile of MSCs, providing reassurance regarding their use in therapeutic applications.

MSCs are known for their genomic stability and limited capacity for self-renewal and proliferation. This means they cannot divide and transform uncontrollably, like cancer cells do.

Additionally, before being used in treatments, MSCs undergo rigorous testing to ensure their purity, viability, and sterility, including checks for any genetic mutations that could lead to cancer.

The FDA’s approval process is extensive and time-consuming, so it is currently a work in progress. However, that does not automatically mean stem cell therapy is unsafe or poorly researched—it just has not yet made its way into the official United States recommendations.

Despite not yet being included in official treatment guidelines, mesenchymal stromal cells are already considered safe for use in specific medical contexts. Numerous clinical trials and research studies have demonstrated their safety and potential efficacy for various conditions. Many countries and regions around the world, including Europe, have already recognized the safety and therapeutic potential of MSCs and have established regulatory pathways for their use.

In Serbia, as well as in many European countries, regenerative medicine is subject to strict regulations and oversight to ensure patient safety and treatment efficacy. Our clinic adheres to all applicable European and Serbian healthcare standards and regulations.

Like all medicine, stem cell therapy can’t be 100% effective for everyone.

Rather, it is an alternative approach worthy of consideration. For hard-to-treat and rare conditions, it can contribute to symptom alleviation, enhance overall quality of life, and slow down disease progression. For more common health conditions, it has the potential to improve the symptoms significantly.

Although up to 80% of our patients experience improvements both during and after the treatment, we cannot guarantee that this will be the case for each individual patient. The success of the treatment largely depends on the diagnosis, overall health, age, and many other factors.

This, however, is what we can guarantee:

• the safety and quality of stem cells products;
• the qualifications of our medical professionals;
• holistic approach, with the treatment program tailored specifically for your needs;
• all-inclusive treatment, with all the necessary check ups and additional procedures;
• safe, comfortable, and homely atmosphere in the clinic;
• free follow-up check ups from our doctors and advisers to ensure the maximum result.

To find out whether stem cell therapy is likely to yield significant improvements in your case, please contact us to book a free, in-depth consultation with our doctors.

All reviews on our YouTube channel feature real patients who have been in our clinic and agreed to share their experience.

If you are interested in speaking to some of them, please contact us. We will first ensure that the patient doesn’t object to sharing their experience further. If they give their consent, we will be able to share their contact information with you so you can make sure they aren’t actors and ask further questions.