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Are Stem Cells Legal in Medicine?

Find out if pluripotent mesenchymal stem cells are legal in regenerative medicine. Find out what federal regulations and certifications your provider needs to make their application of stem cells legal.

Yes, pluripotent mesenchymal stem cells are legal in medicine. Holistic Bio Spa provides 100% legal and certified stem cells from Latin America’s top stem cell banks licensed by the COFEPRIS (Mexico’s Federal Health Ministry equivalent to the FDA).

In our sterilized clinical environments, quality and safety are the #1 priority. We follow international standards that are more rigorous than North American standards to ensure superior results.


Quality standards and federal licenses for stem cell treatment

In the list to follow, view our labs’ stem cell medical licenses confirmed in the Federal Health Ministry directory and Holistic Bio Spa’s international-standard quality control of treatments with mesenchymal stem cells (which is based on the following regulations and licenses) for ethical cell therapy and a safe clinical environment.

  • Passed COFEPRIS (Mexico’s FDA-equivalent authority) regulations for extraction, harvesting, processing, storage, and application of ethically-sourced mesenchymal stem cells that never harm the baby or mother.
  • License #14-TR-14-039-0009 for transplanting stem cells.
  • License #18-TR-02-004-0001 for use of stem cells in regenerative medicine.
  • License #18-TR-14-039-0002 for safe storage and processing of stem cells.
  • License #18-TR-14-039-0003 for screening, collection, and harvesting stem cells.
  • CAT Standards for the Obtention, Processing, Storage, and Distribution of Blood Umbilical Cord.
  • FACT-JACIE International standards for the collection, processing, and administration of hematopoietic cell therapy products.
  • ISO 14644: 2016 Standard Air quality in controlled environments.
  • ISO 9001: 2015 Standard Quality Management Systems.
  • GMP Spanish Agency of Medicines and Health Products.


Here are the results of our third-party labs’ screening tests:

  • Cellular concentration per dose (vial): 100×106
  • DNA expression potential of each stem cell per batch: 99.46%
  • Mycoplasmas (antibiotic-resistant bacteria): NEGATIVE
  • HIV antibodies: NEGATIVE
  • Hepatitis B: NEGATIVE
  • Hepatitis C: NEGATIVE
  • Syphilis: NEGATIVE
  • Trypanosomiasis: NEGATIVE


Patient Testimonials: Does Stem Cell Therapy Work?

I had a bike accident and I had been living my life with enormous pain in my hip. We made the decision ... treatment with stem cells. I didn't really know about it, but Dr. Zoli explained in such a great way. And the therapy ended with such a great, great thing, I just got back my life! I'm not living my life with constant, 24-hour pain in my hip!

Szilveszter • European stem cell therapy patient at Holistic Bio Spa

Came here for stem cell treatment and we are enjoying many of their other services. Love this place and the staff. All very kind, caring and professional. I highly recommend them to everyone!

Mary Reichert • patient review of Holistic Bio Spa on Facebook

Frequently Asked Questions About Stem Cells Used Legally in Medicine

Federal Health Ministry Certifications


Our labs’ quality control is based on the highest international clinical standards and they are active members of the Stem Cell Association of Latin America.

Stem cells are legal to use in regenerative medicine if your provider has FDA or equivalent approval to transfuse or transplant stem cells. At our stem cell therapy clinics in Puerto Vallarta and Nuevo Vallarta, we use 100% ethically-sourced stem cells that are approved by the federal health ministry for use in regenerative medicine.

We obtain all our mesenchymal stem cells from these cryobanks for use in intravenous stem cell therapy and implanting compatible tissue with stem cells. As you can see in the accompanying documents, all of our labs have licenses to extract, harvest, store, and administer stem cells for medical purposes.


What types of stem cells are safe to use in medicine?

  • + Self-extracted stem cells
    iPSCs are adult stem cells extracted from your own body, such as those involved in bone marrow transplants or various forms of prolotherapy, but these are limited to becoming that specific type of cell; in other words, an extracted red blood cell cannot become a brain cell, heart cell, nor a lung cell.

    Autologous stem cells are extracted, cultivated, and harvested from your own bone marrow. These marrow-derived mesenchymal stromal cells (BM-MSCs) have a high success rate because they are already programmed to your DNA.


  • + Allogeneic Donor stem cells
    Allogeneic stem cells are extracted from a qualifying donor (usually a relative), cultivated, and harvested to generate high-quality stem cells for your body.
  • + Pluripotent mesenchymal stem cells
    Mesenchymal stem cells are responsible for the proper formation of organs, bones, cartilage, skin, hair, nerves, and more. With just one injection, we administer a dose of millions of stem cells! These mobilize quickly in the body looking for areas that need help and regenerates into those specific types of tissue or nerves. Almost instantly, the causes of pain, autoimmune diseases, and chronic degenerative disorders (like Parkinson’s and Alzheimer’s) begin to reverse. And that’s just one dose in the treatment protocol.

    Umbilical cord and placenta stem cells are ethically sourced from the placenta and umbilical cord (never harming the embryo itself) of a healthy, carefully screened new mother within her 1st trimester. All stem cells have restorative properties that can be applied in treating medical conditions. These stem cells especially are teeming with 100% natural growth potential thanks to the wondrous processes during pregnancy and can:

    • Heal cancer-infected organs and tissues.
    • Speed up the recovery time from injuries or surgeries, even preventing the formation of scar tissue.
    • Reduce pain—especially joint pain caused by chronic disease.
    • Increase range of motion, flexibility, and sleep quality.
    • Repair nerve damage and regenerate brain cells.
    • Increase collagen—when used for aesthetic procedures.
    • Reduce and restore hair loss.

The COFEPRIS granted these federal licenses recognizing our labs as legal Stem Cell Banks nationwide and authorizing the ethical collection and management of stem cells in Mexico.


Are stem cells legal? Stamped and signed COFEPRIS Stem Cell Bank Legal Certification in Mexico Are stem cells legal? Stamped and signed COFEPRIS Stem Cell Bank Legal Certification in Mexico

Are stem cells legal? Stamped and signed COFEPRIS Stem Cell Bank Legal Certification in Mexico Are stem cells legal? Stamped and signed COFEPRIS Stem Cell Bank Legal Certification in Mexico


Video Testimonials About Stem Cell Therapy

Click play and watch what respected peers in the world medical community and real patients say about the healing power contained in stem cells.

‘‘Robert looked at me like I was crazy and said, ‘But Sandrine, these are adult patients—adults do not grow new nerve cells.’ And much to his surprise, I said, ‘Well, actually, we do.' Robert isn't a neuroscientist..."

– Neuroscientist Sandrine Thuret

‘‘He said there is no cure, and I was pregnant with twins. It was absolutely devastating to know that I would be a mom and that I would eventually go blind.”

– Rosie Barrero, recovering her sight thanks to stem cell therapy

‘‘I was diagnosed with cancer in March of 2015. They said, ‘You’ve got cancer and unfortunately it’s metastasized to your liver and it’s also moved to your lungs as well.’"

– Tom Howing, stage 4 cancer vanished thanks to stem cell therapy

What Medical Conditions Can Stem Cells Treat?

  • Sports Injury
  • Skin & Facial Rejuvenation
  • Orthopedic Conditions
  • Neurological Disorders
  • Sexual Wellness
  • Anti-Aging and Preventative
  • Diabetes
  • Macular Degeneration
  • Chronic Fatigue
  • Chronic Pain
  • Multiple Sclerosis
  • Stroke
  • Heart Disease
  • Kidney Disease
  • Liver Disease
  • Lung Disease
Patients consulting with one of our health experts about alternative medicine treatments and financing

FREE Telemedicine Evaluation!

Zero commitments, zero judgments, and zero risk — just a free virtual case evaluation where you will meet with one of our Patient Advisors to make sure we can provide the right treatments for your condition (before you jump on a plane).

Subsequently, one of our doctors may conduct a medical review of your case:

  • HIPAA compliant review of medical history and lab results

  • Virtual consultation with an expert matched to your needs

  • Proposed treatment plan PDF with timeline and budget

So, are you ready to take control of your health?

Contact Our Doctors For Stem Cell Treatments

Our doctors work only with certified cryobanks to get the right type of stem cells for your condition. Schedule a consultation to talk about how you can harness the healing power of stem cells!
  • United States
  • Canada
  • Australia
  • Europe
  • Central America
  • Puerto Vallarta
  • Bucerias
  • Punta Mita
  • Marina Vallarta
  • Nuevo Vallarta
  • Mismaloya
  • Amapas