Is Stem Cell Therapy Safe?

Stem cell therapy is transforming modern medicine, offering treatments for conditions once thought untreatable — from restoring vision to helping people with diabetes produce insulin.

But here’s the catch: while the results can be groundbreaking, the safety of stem cell therapy depends on factors that aren’t always obvious. How can you tell if a treatment is truly safe and effective? Keep reading to discover the facts, debunk myths, and find out how to ensure you’re in the best hands for this revolutionary treatment.

Table of Contents

What Research Says About the Safety of Stem Cell Therapy

Human stem cell research shows that the therapy is safe when performed by reliable healthcare providers in controlled clinical settings. Here are insights from research on some of the most popular stem cell applications:

• Osteoarthritis. A large two-year case series demonstrated that adult stem cells are safe for treating knee osteoarthritis. It can delay or even prevent the need for knee joint replacement surgery.
• Parkinson’s disease. A clinical trial by BlueRock Therapeutics found stem cell therapies to be safe for patients with advanced Parkinson’s disease, with minimal side effects. Imaging confirmed that the injected stem cells could survive and successfully integrate with the existing brain cells.
• Autism. Reviews of multiple clinical trials showed that stem cell therapy does not cause severe adverse effects and can measurably reduce autism symptoms (according to the Childhood Autism Rating Scale (CARS)).
• Eye diseases. In a large study involving nearly 500 eyes, 97.8% of treatments had no side effects. When adverse events were reported, they were not serious or systemic.
• Back pain. Studies spanning up to 6 years confirm that adult stem cells are safe for back pain, with very few adverse events. Minor side effects, such as headaches and musculoskeletal pain, are temporary and resolved with over-the-counter medications.
• Spinal cord injuries. A study by the Mayo Clinic revealed that adult stem cells are safe for treating traumatic spinal cord injury. The research also indicated improvements in sensation and movement.
• Diabetes. Stem cell therapy for diabetes has shown a strong safety profile, with most side effects being mild and temporary. Moreover, human stem cells restore insulin production, with some patients reducing external insulin use by 91% or becoming completely insulin-independent.

Are Stem Cell Therapies Safer in Some Countries Than Others?

Where you receive treatment can make all the difference. Different countries have approved different therapies based on their regulatory standards. Opting for a stem cell treatment in a country where it is not official will leave you less protected against risks.

🗽 Regulations in the USA

In the United States, the Food and Drug Administration (FDA) has approved only a limited number of treatments—mainly for blood-related disorders such as leukemia. Most other applications of stem cells have not yet passed the approval process in the US.

Although nearly 3,000 clinics across the US offer unproven treatments for a wide range of conditions, they carry significant risks:

• No guarantee of quality control. Clinics may use improperly sourced or processed stem cells.
• Ineffective dosages. Lower doses used to bypass regulations may not provide the desired therapeutic effects.

🌍 Regulations abroad

The global regulatory landscape for stem cell therapy is diverse, with some countries embracing the treatment more fully than the US. These include:

• Mexico. Stem cell therapies are regulated by the Federal Commission for Protection against Sanitary Risks (COFEPRIS).
• Colombia. Governed by the National Institute of Food and Drug Monitoring (INVIMA), which oversees treatment safety and efficacy.
• Turkey. Regulated by the Turkish Ministry of Health.
• Thailand. Controlled by the Thai Food and Drug Administration (Thai FDA).
• South Korea. Overseen by the Ministry of Food and Drug Safety (MFDS).
• Israel. Managed by the Ministry of Health, with a strong focus on clinical trials.
• Poland. Regulated by the Ministry of Health, ensuring compliance with EU medical standards.
• Ukraine. Overseen by the Ministry of Health, with growing recognition for innovative stem cell applications, including fetal stem cells.

While these countries have varied regulatory approaches, they allow treatments that remain unapproved in the US.

Stem Cell Types and Their Safety

Different types of stem cells have varied sources, functions, and safety profiles. Stem cells most often used in treatments are:

1. Mesenchymal stem cells (MSCs)

• Source: Bone marrow, fat tissue, umbilical cord blood and tissue, amniotic fluid.
• Description: A subtype of adult stem cells that can differentiate into cartilage, fat, and bone cells. Mesenchymal stem cell therapy is based on their anti-inflammatory and regenerative properties.
• Safety: Highly safe, especially when derived from the patient (autologous), with a low risk of immune rejection. Mesenchymal stem cells are widely used in clinical applications.

2. Human embryonic stem cells (ESCs)

• Source: Stem cells derived from early-stage human embryos, usually discarded after unsuccessful in vitro fertilization (IVF).
• Description: Pluripotent stem cells that can become almost any cell type in the body, extremely versatile.
• Safety: While promising, human embryonic stem cells carry risks such as immune rejection and tumor formation (teratomas), as well as some ethical concerns. They are still primarily used in research.

3. Induced pluripotent stem cells (iPSCs)

• Source: Created by reprogramming adult stem cells (e.g., skin or blood) to behave like embryonic stem cells.
• Description: Pluripotent stem cells with embryonic-like properties. Since they are created from a patient’s adult stem cells, this eliminates the risk of an immune response and ethical concerns.
• Safety: Experimental, with risks of genetic instability and tumor formation. These stem cells are not yet widely used in clinical therapies.

Stem Cell Administration Methods and Their Safety

The method used to deliver stem cells is critical for the therapy's safety and effectiveness. Here’s an overview of the most common methods:

1️⃣ Stem cell injections

• How it works: Stem cells are injected directly into the affected area.
• Safety: It is generally safe and minimally invasive. Precision is crucial to avoid complications such as infection, bleeding, or incorrect placement.
• Applications: Joint repair (e.g., arthritis), tendon injuries, and localized tissue regeneration.

2️⃣ Intravenous administration

• How it works: Stem cells are delivered into the bloodstream through an IV. They travel throughout the body and target multiple areas.
• Safety: Low risk if administered properly, though potential side effects include mild immune responses or blood clots if the cells are not adequately processed.
• Applications: Autoimmune diseases, systemic inflammation, and general regenerative therapies.

3️⃣ Intrathecal (spinal) administration

• How it works: Stem cells are injected into the cerebrospinal fluid via the spine for targeted delivery to the central nervous system.
• Safety: Requires high precision and expertise, as improper technique can cause nerve damage or infection.
• Applications: Neurological conditions like multiple sclerosis, spinal cord injury, or ALS (amyotrophic lateral sclerosis).

4️⃣ Surgical implantation

• How it works: Stem cells are implanted directly into an organ, tissue, or scaffold during surgery to promote regeneration.
• Safety: Carries higher risks due to the surgical nature of the procedure, including infection, scarring, or complications from anesthesia.
• Applications: Organ regeneration, repairing large tissue defects, and advanced treatments for spinal injuries.

Potential Side Effects and Risks of Stem Cell Therapy

As with any medical treatment, it carries certain risks. However, most side effects are mild and temporary, especially when the therapy is delivered under proper protocols.

Common side effects

1. Reactions at the injection site. Patients may experience mild redness, swelling, or discomfort at the site of injection. These usually resolve within a few days without further complications.

2. Temporary pain or stiffness. Some patients report mild joint or muscle soreness following treatment, which improves with time or over-the-counter medication.

3. Fatigue and discomfort. Common after therapy as the body adapts to the regenerative process.

Less common risks

1. Immune system response. Although this is rare, stem cells derived from a donor (allogeneic) could cause immune reactions with symptoms like fever or inflammation. This can be mitigated through proper screening or by using the patient’s adult stem cells.

2. Infection. Any procedure involving injections or surgical implantation carries a minor risk of infection, which can be minimized with proper sterilization. Using high-quality stem cells and following proper aftercare instructions will also help prevent infections.

Contraindications for Stem Cell Therapy

While stem cell therapy has proven safe and effective for many conditions, it’s not suitable for everyone. Certain health conditions or circumstances can increase the risks associated with the treatment.

1️⃣ Active infections

If you’re dealing with a bacterial or viral infection, stem cell treatment should be postponed. Treating the infection first helps prevent complications during or after the medical procedure.

2️⃣ Cancer or recent history of cancer

Stem cell therapies designed to treat cancer, such as bone marrow transplants, are well-established and effective. They are specifically designed to replace damaged blood cells and rebuild the immune system after chemotherapy or radiation.

However, other types of stem cell treatments are not suitable for individuals with active cancer or a recent history of cancer. Stem cells promote growth and repair by releasing signals that encourage cell regeneration. In people with cancer, these signals can accidentally stimulate the growth of cancer cells nearby.

3️⃣ Uncontrolled health conditions not targeted by the therapy

For stem cell treatment to be safe and effective, patients must have stable overall health. If you have uncontrolled health conditions that aren’t the focus of the therapy, the risks can outweigh the potential benefits.

For example, while stem cell therapy may target joint repair or neurological recovery, underlying issues like poorly managed chronic conditions or systemic inflammation could complicate the procedure or recovery process. Stabilizing these conditions beforehand is essential to ensure the best possible outcomes from the therapy.

4️⃣ Pregnancy and breastfeeding

There’s simply not enough research to say stem cell therapy is safe during pregnancy or breastfeeding, so it’s best to wait until after.

5️⃣ Allergies to medications or anesthesia

If you have known allergies to medications used during the procedure, your doctor must assess and adjust the approach to minimize risks.

Other considerations

Stem cell treatment may not be recommended for:

• Elderly patients with significant frailty. Advanced age alone isn’t necessarily a contraindication, but weakness and poor health can make the procedure unsafe or less effective.
• Obese patients, as obesity can increase complications during the procedure.
• Smokers, due to impaired tissue regeneration and healing.

How to Prepare for Stem Cell Therapy

Although stem cell treatment doesn’t require extensive preparation, it doesn’t come down to just about showing up for the procedure. By preparing correctly, you can get the most out of the therapy and lower potential risks. Here’s how to get ready:

1️⃣ Undergo a full check-up

Your doctor will need to understand your overall health before recommending stem cell treatment. Be honest about your medical history and undergo any necessary tests.

2️⃣ Adjust lifestyle habits

• Quit smoking. Smoking reduces your body’s ability to heal and can compromise the effectiveness of stem cells. Aim to quit at least several weeks before the procedure.
• Improve nutrition. Focus on a diet rich in fruits, vegetables, lean proteins, and healthy fats to boost your body’s natural regenerative abilities.
• Exercise regularly. If your condition allows, light to moderate exercise can improve circulation and help your body prepare for recovery. Even a daily walk can make a difference but always check with your doctor first.

3️⃣ Keep your health conditions in check

If you have conditions like diabetes or high blood pressure, make sure they’re under control. Follow your doctor’s recommendations to keep these conditions under control.

4️⃣ Double-check your meds

Some medications, like anti-inflammatory drugs or blood thinners, might interfere with the treatment. Your doctor will let you know if you need to stop or adjust anything beforehand.

5️⃣ Stay hydrated

Drink plenty of water in the days leading up to your treatment. Staying hydrated helps your cells function better and sets you up for a smoother recovery.

6️⃣ Plan for recovery

Arrange for transportation and prepare your home for a comfortable recovery. Stock up on things you might need, such as ice packs or over-the-counter pain relievers.

7️⃣ Follow your doctor’s instructions

Every stem cell treatment is different, and your clinic will give you specific guidelines for your case. These instructions will optimize the therapy’s effectiveness and ensure your safety, so make sure to follow them closely.

How to Choose a Safe Stem Cell Therapy Clinic

Finding the right stem cell clinic is arguably the most important factor determining the safety and success of therapy. With so many options out there, it’s easy to feel overwhelmed. Here are some tips to help you make an informed choice:

1️⃣ Verify licensing and accreditation

Check that the clinic is licensed and accredited by the relevant health authorities in its country. Clinics operating under regulatory oversight offer properly processed stem cells and follow strict safety protocols.

2️⃣ Research the clinic’s track record

Look for reviews and testimonials from patients who have undergone similar medical treatments. Use reputable platforms like Google Reviews or check the Bookimed website. Be cautious of clinics that lack verifiable patient feedback.

3️⃣ Confirm the type of stem cells

Ask the clinic to specify the source (autologous or allogeneic) and type of stem cells they use (e.g., mesenchymal stem cells, embryonic stem cells, etc.). Ensure these stem cells are appropriate for your condition. Verify that the clinic sources and handles them according to regulatory standards.

4️⃣ Look into the medical team’s credentials

A reputable clinic will have experienced and qualified doctors specializing in regenerative medicine. Don’t hesitate to ask about the team’s training and expertise in stem cell-based procedures.

5️⃣ Ask about the treatment protocol

A trustworthy clinic will clearly explain its step-by-step treatment process. Be wary of clinics that avoid providing details or seem vague about the procedure.

6️⃣ Check if the clinic conducts a medical evaluation

Reputable clinics will perform a thorough medical evaluation to assess your suitability for the therapy. If a clinic offers immediate approval without reviewing your health history, it’s a red flag.

7️⃣ Ask about post-treatment support

Good clinics provide comprehensive follow-up care to monitor your progress and address any complications. This shows they are invested in your long-term results.

8️⃣ Pay attention to communication

Doctors who take the time to answer your questions are more likely to prioritize your safety and satisfaction. Poor or rushed communication can be a sign of disorganization or lack of professionalism.

9️⃣ Beware of false promises

Be skeptical of stem cell clinics that guarantee miraculous results or claim their therapy is a “cure-all.” Legitimate institutions will set realistic expectations based on your condition. Research their claims and look for evidence from peer-reviewed studies or reputable medical sources.

Top Clinics for Safe Stem Cell Therapy

Bookimed has compiled its top 10 verified clinics for stem cell therapy to help you make a safe decision. Guided by our Ranking Policy, we considered clinics’ accreditations, availability of comprehensive treatment programs, patient reviews, and efficiency.

1. Cellular Hope Institute

📍 Cancún, Mexico

🌟 Why this clinic:

• Accredited by the Mexican General Health Council and the Canadian Accreditation Council.
• Over 12 years of experience in regenerative medicine.
• Equipped with a state-of-the-art cell culture lab and cryopreservation unit.
• Trusted by high-profile patients like Mike Tyson and Cristiano Ronaldo.
• Uses different types of stem cells, including allogeneic and autologous mesenchymal stem cells and umbilical cord blood stem cells.

💵 Cost: $7,000-$30,000.

🎯 Best for: Autoimmune diseases, orthopedic conditions, neurodegenerative disorders.

2. ID Clinic Bangkok

📍 Bangkok, Thailand

🌟 Why this clinic:

• Accredited by the Royal College of Surgeons Thailand.
• Uses mesenchymal stem cells from rigorously screened umbilical cord donors.
• Led by experienced specialists, including Dr. Wuttiphan (>20 years in stem cell treatments) and Dr. Kraisornphongsakul (>30 years in aesthetic medicine).
• Treats over 4,000 international patients annually.

💵 Cost: $1,200-$7,500.

🎯 Best for: Autoimmune diseases, joint pain, hair loss, rejuvenation.

3. Memorial Şişli Hospital

📍 Istanbul, Turkey

🌟 Why this clinic

• Turkey’s largest multidisciplinary medical center.
• 1st hospital in Turkey to receive JCI accreditation.
• Treats over 1.6 million patients from 92 countries annually.

💵 Cost: $3,500-$8,000.

🎯 Best for: Oncology, neurology, orthopedics.

4. Liv Hospital Ulus

📍 Istanbul, Turkey

🌟 Why this clinic:

• Licensed by the Turkish Ministry of Health to cultivate and use stem cells.
• Offers innovative therapies, including stem cell-based facial fillers and post-cancer breast reconstruction.
• Holds GMP certification and complies with global quality standards.

💵 Cost: $8,000-$15,500.

🎯 Best for: Orthopedic conditions, skin treatments, breast reconstruction.

5. Immunotherapy Regenerative Medicine

📍 Puerto Vallarta, Mexico

🌟 Why this clinic:

• Over 20 years of experience in regenerative medicine.
• Uses fresh, non-frozen adult stem cells for enhanced treatment effectiveness.
• A multidisciplinary team of internationally recognized biologists, biochemists, and nutritionists.

💵 Cost: $4,000-$28,000.

🎯 Best for: Immunology, chronic diseases, anti-aging, sports injuries.

6. Medical Center Juventa

📍 Playa del Carmen, Mexico

🌟 Why this clinic:

• Led by Dr. Isabella Bernaschina, an expert certified by RCG, Mexico’s leading regenerative medicine association.
• Its patient-centric approach and focus on individualized care set it apart.

💵 Cost: $7,000-$11,000.

🎯 Best for: Orthopedics, diabetes, Parkinson’s disease, HIV treatment, alopecia, rejuvenation.

7. Medipol Mega University Hospital

📍 Istanbul, Turkey

🌟 Why this clinic:

• One of Turkey’s largest and most advanced hospitals with a JCI accreditation.
• Treats over 1,200 patients daily and 1 million patients yearly.
• A leader in joint disorder treatments.

💵 Cost: $4,000-$10,000.

🎯 Best for: Joint diseases, bone marrow transplants.

8. Giostar

📍 Cancún, Mexico

🌟 Why this clinic:

• An international leader in stem cell research, headquartered in San Diego, California, and certified by COFEPRIS.
• Founded by leading U.S. researchers and connected to prestigious institutions, including the University of California.

💵 Cost: $8,000-$9,000.

🎯 Best for: Anti-aging, muscular injuries, degenerative diseases, arthritis, sports injuries.

9. Reju Medical Clinic

📍 Medellín, Colombia

🌟 Why this clinic:

• Uses mesenchymal stem cells sourced from a COFEPRIS-licensed lab.
• Employs a highly experienced medical team with over 15 years in regenerative medicine.

💵 Cost: From $5,000

🎯 Best for: Orthopedics, chronic diseases, diabetes, autism, autoimmune diseases, neurodegenerative disorders.

10. R3 Life Wellness Center

📍 Bangkok, Thailand

🌟 Why this clinic:

• Accredited by the Thai Cell Therapy Association and the American Board of Anti-Aging and Regenerative Medicine (ABAARM).
• Collaborates with global stem cell banks for high-quality stem cell sourcing.

💵 Cost: $3,500 - $16,500

🎯 Best for: Facial and body rejuvenation, inflammation, hair growth, erectile dysfunction.