Is Therapy Legal in the US? A Comparative Guide to Global Regulations

therapy is one of the most promising advancements in modern medicine. It is being hailed for its ability to regenerate tissues, reduce inflammation, and tackle medical conditions that were once thought untreatable. 

But as exciting as it sounds, navigating the legal status—especially in the US—can be tricky. Patients are often left wondering whether these breakthrough treatments are even allowed. In this article, we’ll untangle US regulations and look at other countries where you can find safe, legal treatments.

Table of Contents

1. Are Legal in the US?
2. Where Is Therapy Legal?
3. Protecting Yourself: Ethical and Safety Considerations for Patients
4. How to Choose a Reliable and Safe Cell Clinic
5. Key Takeaways

Are Legal in the US?

Short answer: Partly. Only certain therapies, like those for blood disorders, are FDA-approved and legal. Most treatments haven’t yet passed the necessary approval process.

FDA’s role in regulation

The Food and Drug Administration (FDA) regulates the safety and effectiveness of medical treatments, including therapies. treatments must undergo clinical trials and receive FDA approval to be legal. This ensures they meet safety and efficacy standards before being offered to the general public.

What are the FDA-approved therapies?

Currently, the only FDA-approved treatment in the US is hematopoietic transplantation (HSCT). This therapy uses from umbilical cord blood to treat certain cancers and disorders affecting the blood and immune sy, such as leukemia.

Still, there’s a lot of hope on the horizon. Although the FDA hasn’t greenlighted many treatments for general use, they do approve a significant number of clinical trials. In fact, over 5,000 registered clinical trials in the US are currently gathering proof of therapy’s safety and effectiveness. Clinical trials are a critical step in expanding the approved uses of in medicine.

Limitations of therapy in the US

Despite FDA regulations, almost 3,000 clinics in the US offer unproven therapies for a wide range of medical conditions. These clinics try to bypass FDA regulations by:

• Labeling treatments as “experimental”. Some clinics market their treatments as part of ongoing research. However, it may lack proper oversight or adherence to safety protocols.
• Using patient-funded trials. Some clinics offer treatments through so-called clinical trials where patients pay for the therapy, blurring the line between research and commercial services. 
• Operating under state-level laws. Some clinics take advantage of less stringent state regulations, allowing them to offer treatments that wouldn’t pass under federal FDA guidelines.
• Offering reduced dosages. Some clinics use reduced dosages of to circumvent FDA regulations, claiming their treatments are not technically “ products.”

While these methods enable clinics to offer unapproved treatments, choosing one of these clinics may come with real risks. Here’s why:

• Safety concerns. A key issue with unapproved therapies is the lack of quality control. Without FDA oversight, there is no guarantee that the are being correctly handled and processed. Some clinics may use from unproven sources, which could be less effective or even harmful.
• Ineffective dosages. Some clinics lower the amount of used in treatments to avoid FDA oversight. However, research shows that higher dosages often produce better results. Reduced doses may not be effective enough to repair or regenerate damaged tissue properly.

research and clinical trials in the US

The lack of FDA approval for treatments doesn’t mean they’re not considered effective by U.S. scientists. In fact, numerous FDA-approved clinical trials have shown that therapies are safe and effective in multiple application areas, such as orthopedic, neurological, and heart conditions. 

However, FDA approval is required to ensure that treatments in the US undergo rigorous testing before being marketed. This ensures that the therapies meet safety standards, are properly regulated, and provide reliable outcomes for patients.

Where Is Therapy Legal?

therapy is gaining traction worldwide, but the legal landscape varies significantly from one country to another. While the US has strict regulations, some nations have embraced treatments more fully. Here’s a quick overview of the most prominent destinations for legal therapy:

North and South America

✈️ Mexico

Mexico’s regulatory framework for therapies is more flexible than in the US. It allows clinics to offer treatments that are still in clinical trials elsewhere. The Federal Commission for Protection against Sanitary Risks (COFEPRIS) allows treatments in regenerative medicine, including orthopedic and neurological conditions. 

However, obtaining a COFEPRIS license for therapy takes work. The clinic must provide extensive documentation to prove its safety and compliance with regulations regarding the facility, equipment, procedures, and medical staff training.

To conduct therapy, clinics need to obtain specific licenses, such as:

• Cell Collection License (for harvesting cells mesenchymal );
• Surgery Room License (for performing procedures);
• Regenerative Medicine License (to legally offer treatments).

These licenses ensure clinics meet strict standards for safety, equipment, and medical expertise.

The Bookimed team has compared over 150 clinics worldwide according to the Ranking Policy. This policy takes into account the clinic’s accreditations, reputation, patient demand, and feedback. As a result, we have identified the top clinics in Mexico offering COFEPRIS-approved therapies:

✈️ Colombia

Colombia’s National Institute of Food and Drug Monitoring (INVIMA) governs the regulation of therapies. Several laws and decrees ensure that collection, storage, and clinical use meet high safety and ethical standards. Before conducting any treatment, clinics should rigorously test for diseases and disease agents.

Middle East

✈️ Turkey

therapy in Turkey is regulated by the Turkish Ministry of Health. Additionally, the Turkish Academy of Sciences and TÜBA Cell Work Group support research in the country. The group also organizes conferences, symposiums, and research projects to foster collaboration between national and international scientists.

Check out Turkey’s leading clinics licensed to provide therapies by the Ministry of Health:

✈️ Israel

Israel is a pioneer in research, with the Ministry of Health ensuring strict oversight of therapies. 

Israeli scientists played a pivotal role in developing CRISPR gene-editing technology, which can help create universal treatments without the risk of immune rejection.

✈️ Netherlands

In the Netherlands, research and treatments are regulated by the Dutch Healthcare Inspectorate and the Dutch Central Committee on Research Involving Human Subjects (CCMO). They allow only treatments that are proven safe. Therapies are closely monitored under clinical trial conditions. Most recently, the Dutch government approved treatment for multiple sclerosis (MS).

The country has a robust scientific community actively involved in research. In 2022, researchers from Leiden University Medical Center (LUMC) successfully used therapy to treat a baby with severe combined immunodeficiency (SCID)—the first successful case of its kind in history.

✈️ Switzerland

In Switzerland, therapies are tightly regulated by Swissmedic, the national regulatory body for therapeutic products. treatments must comply with the Transplantation Act and the Therapeutic Products Act.

Clinics offering treatments in Switzerland must hold an establishment license from Swissmedic. It ensures strict adherence to legal and medical standards.

✈️ Poland

treatments are legal in Poland. They are regulated directly by the Ministry of Health. The country is also home to the Polish Cell Bank PBKM, the head of Europe's largest network of .

Here are Poland’s most trusted clinics:

✈️ Ukraine

Ukraine has emerged as a hub for affordable and innovative treatments, with fewer regulatory hurdles than in other European countries. The Ukrainian Ministry of Health regulates treatments, products, and clinical trials. All medical staff and clinics involved in therapies must comply with the regulations developed by the Ministry.

Ukrainian clinics offer therapies that are still in trial stages in other countries. For instance, Ukraine is the only country that offers legal and regulated fetal therapy. It is home to the world’s first fully licensed fetal bank, owned by the EmTherapy Center. 

Here are the most prominent clinics in Ukraine offering licensed therapies:

Asia

✈️ Thailand

In Thailand, the Thai Food and Drug Administration (Thai FDA) regulates therapies. Doctors must obtain scientific and ethical approval from the Medical Council to provide therapies. 

The focus areas of research and application in Thailand include:

• treatments for diabetes;
• peripheral vascular disease;
• coronary artery disease;
• ischemic stroke;
• spinal cord injuries;
• amyotrophic lateral sclerosis (ALS);
• traumatic brain injuries.

Explore the best clinics in Thailand offering TFDA-regulated treatments:

✈️ South Korea

South Korea offers numerous treatments approved by the Ministry of Food and Drug Safety (MFDS). The Ministry of Health provides targeted funding to boost research in both rare diseases (such as spinal cord injuries) and common chronic conditions like arthritis.

South Korea is a leader in regenerative medicine, with the second-highest number of approvals for therapies worldwide. Its expedited approval process helps bring innovative treatments to market more quickly. Meanwhile, the process ensures patient safety through required long-term follow-ups. 

For world-class treatments, explore South Korea’s top clinics:

Protecting Yourself: Ethical and Safety Considerations for Patients

therapy is still a developing field, so it’s essential to be extra cautious and well-informed. Here are some critical points to keep in mind when considering treatment:

1. Consider ethical implications

Not all types of are viewed the same in terms of ethics. One of the most debated areas is the use of from human embryos, typically left over from () treatments. Since obtaining these cells destroys the embryo, this raises ethical concerns.

On the other hand, some argue that since these embryos would otherwise be discarded, using them for medical purposes serves the greater good. You need to decide where you stand on this issue and be aware of what your treatment will involve.

2. Consult a licensed medical professional first

Always consult a licensed and qualified doctor before considering any therapy. If you’re unsure where to start, Bookimed can connect you with reputable specialists and clinics worldwide for a free consultation.

3. Understand the regulations in the chosen country

Various countries have different regulations surrounding therapy. Make sure the country you're considering has a strong regulatory framework in place to protect patients and ensure treatments are scientifically validated.

4. Ensure scientific validation 

Make sure therapy for your condition is backed by peer-reviewed research and has been validated in clinical trials. You can check clinical trial data on platforms like ClinicalTrials.gov or search for published research on sites like PubMed. These platforms provide data on ongoing and completed research.

5. Beware of misleading claims

Be cautious of clinics promising miracle cures or claiming treatments for unapproved uses. therapies are still experimental treatments for many conditions, so verify whether the therapy is part of a legitimate clinical trial or simply unproven.

6. Understand potential complications

Although clinical trials indicate the relative safety of treatments, there can still be side effects depending on the type of and the treated condition. Ask your doctor about the short- and long-term risks of the specific treatment you are considering.

7. Don’t rush your decision—consider all alternatives

Take your time to evaluate whether therapy is the best course of action for you. Be cautious of any pressure to make quick decisions or commit to immediate treatment without exploring other options.

How to Choose a Reliable and Safe Cell Clinic

With various clinics and treatments available worldwide, here are key steps to help you make informed decisions about your health:

1. Research the clinic’s credentials and certifications for therapy

Ensure that the clinic complies with regulatory standards in the country, such as those set by the FDA in the U.S. or equivalent organizations elsewhere. Accredited clinics provide scientifically backed, safe treatments.

2. Verify safety protocols

Make sure the clinic follows strict safety protocols for handling, processing, and administering . Compliance with guidelines reduces risks such as contamination or infections.

3. Read reviews and patient onials

Investigate reviews from past patients and ask the clinic’s representatives for success stories. A clinic with a solid reputation will have a history of positive patient experiences that can provide you with a clearer picture of its reliability.

4. Check for informed consent procedures

A reputable healthcare provider will fully inform you about the risks, benefits, and alternative treatments before undergoing therapy. You should never feel rushed into a decision. Avoid clinics that skim over the risks or pressure you to sign paperwork without proper consultation.

5. Ask about post-treatment monitoring and follow-up care

Ethical providers will offer ongoing care after the procedure to monitor for potential side effects or complications. This reflects a commitment to patient well-being beyond just the treatment itself.

6. Look for transparency in pricing and treatment plans

Reliable clinics are upfront about the costs involved. They should offer clear, detailed treatment plans after evaluating your case. There should be no hidden fees or surprise charges after you begin treatment.

7. Avoid clinics that promise miraculous results

Be cautious of language that promises complete recovery or miracle cures without scientific evidence. Reputable providers set realistic expectations and make it clear that results may vary.

Key Takeaways

👉 therapy legality in the US. Only hematopoietic transplantation for blood disorders is FDA-approved and legal. 

👉 Limitations in the US. Many US clinics offer unproven therapies by bypassing FDA regulations. Without FDA approval, these therapies can pose safety risks due to improper handling.

👉 Global options for therapy. Mexico, Colombia, Turkey, Thailand, South Korea, Israel, Germany, Netherlands, Poland, Switzerland, and Ukraine offer therapies that are approved and regulated by FDA-equivalent bodies in these countries. These therapies are monitored for safety and effectiveness under stringent national standards.

👉 Ethical and safety considerations. Before seeking treatment, research types and available research regarding your condition. Make sure to consult a licensed doctor and learn about the benefits and risks associated with the treatment.

👉 Choosing a reliable clinic. Ensure the clinic is licensed by relevant regulatory bodies (e.g., COFEPRIS, INVIMA, Swissmedic) to perform therapies. Look for clinics with clear pricing, positive patient reviews, and post-treatment follow-up care to ensure your safety and well-being. Bookimed can connect you to accredited clinics worldwide.

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