Stem Cell Therapy: The Truth Every Patient Deserves to Know

Stem Cell Therapy Truth:
Every week, patients with chronic pain, neurological conditions, spinal injuries, and degenerative diseases contact clinics around the world — in London, Mexico, Germany, Panama, Thailand, and online — having been told that stem cell therapy will change their life. Many of them have already spent tens of thousands of pounds. Some have been physically harmed. A number have died.. Stem Cell Therapy Truth. Exploring the Stem Cell Therapy Truth.

This is not a fringe issue. This is one of the most urgent patient safety crises in global medicine today.

As a Consultant at the London Sports and Rheumatology Imaging (LSRI), Dr Prashant Sankaye encounters patients who have either received unproven stem cell treatments or are considering them, often out of desperation after conventional medicine has not resolved their condition. This guide exists to provide the honest, evidence-based information that every patient deserves — before making a decision that could cost them financially, physically, and in some cases, fatally.

This is not an anti-science article. Stem cell research is one of the most exciting frontiers in medicine. But there is a vast and dangerous gap between what scientists are researching in controlled clinical trials and what commercial clinics are selling to vulnerable patients. That gap is what this guide is about.

What Are Stem Cells? The Stem Cell Therapy Truth

Stem cells are the body’s raw material — the foundational cells from which all specialised cells develop. Under the right conditions, stem cells divide to form daughter cells that become bone cells, brain cells, heart muscle cells, blood cells, or many other specialised cell types.

There are several types of stem cells relevant to medical treatment:

• Embryonic stem cells — derived from embryos; can become any cell type in the body (pluripotent). Ethically controversial and heavily regulated.
• Adult stem cells (somatic stem cells) — found in tissues throughout the body, including bone marrow and fat. More limited in what cell types they can become.
• Induced pluripotent stem cells (iPSCs) — adult cells reprogrammed to behave like embryonic stem cells. Discovered by Dr Shinya Yamanaka (Nobel Prize 2012). Enormous research potential.
• Haematopoietic stem cells (HSCs) — found in bone marrow; give rise to all blood cells. The basis of bone marrow transplantation and the Stem Cell Therapy Truth.
• Mesenchymal stem cells (MSCs) — found in fat, bone marrow, and connective tissue. Frequently used — and misused — in commercial stem cell clinics.

“Understanding the type of stem cell being offered is the very first question patients should ask — and most commercial clinics cannot answer it with clinical precision. When a clinic cannot tell you the source, the preparation method, the viability, and the evidence base for what they are injecting, that is a serious warning sign.”
— Dr Prashant Sankaye, Consultant, LSRI London

Stem Cell Therapy Truth: Proven Clinical Stem Cell Treatments

This is critically important. There ARE proven, safe, and clinically validated stem cell therapies. The problem is that they are vastly outnumbered by unproven commercial treatments.

Every other stem cell treatment being sold commercially today — for arthritis, back pain, autism, anti-ageing, neurological conditions, and dozens of other conditions — lacks the clinical trial evidence required for regulatory approval in the UK, EU, or US.

This does not mean the research is not happening. It means it has not yet been proven to be safe and effective in the rigorous, systematic way that responsible medicine requires.

The Stem Cell Therapy Truth: Global Industry Crisis

In 2021, the International Society for Stem Cell Research (ISSCR), the leading international professional body for stem cell scientists, updated its guidelines⁴. They state that marketing or providing stem cell-based treatments before their safety and effectiveness have been rigorously and independently reviewed, and before appropriate regulatory approval, is a breach of professional medical ethics. They also say that patients should generally not bear the cost of proving that an experimental treatment is safe and effective⁴.
Despite this, the commercial industry has grown quickly. A 2021 analysis in Cell Stem Cell found 1,480 businesses in the US, operating 2,754 clinics, selling stem cell treatments that are not FDA-approved. That is more than four times as many businesses as five years earlier⁵. Clinics in other countries also market directly to patients abroad, a practice often called ‘stem cell tourism’⁶.

Stem Cell Therapy Truth: What Clinics Claim to Treat

Commercial clinics market stem cell therapies for conditions including:

• Osteoarthritis and joint pain
• Chronic back and neck pain / degenerative disc disease
• Multiple Sclerosis (MS)
• Parkinson’s disease
• Motor Neurone Disease (MND/ALS)
• Autism Spectrum Disorder
• Cerebral Palsy
• Anti-ageing and cosmetic applications
• Erectile dysfunction
• Diabetes
• Heart failure
• Macular degeneration
• Sports injuries

For the vast majority of these conditions, there is no peer-reviewed evidence from Phase 3 randomised controlled trials — the gold standard of clinical proof — to support the use of commercially available stem cell treatments.

“I have seen patients with degenerative spinal conditions spend £20,000–£40,000 on stem cell injections abroad, only to return with no benefit and sometimes with new complications. The tragedy is that they were given hope that had no evidence base. These patients deserved better. They deserved honesty.”
— Dr Prashant Sankaye, Consultant, London Sports and Rheumatology Imaging (LSRI)

Stem Cell Therapy Truth: Seven Patient Red Flags

Stem Cell Therapy Truth: Evidence of Patient Harm

• 2018 (USA): The FDA stem cell enforcement and CDC reported 12 patients who developed serious bacterial infections (Mycobacterium abscessus) following unregulated stem cell injections at a Florida clinic.
• 2021 (JAMA): Documented cases of patients developing spinal tumours (teratomas) after intrathecal stem cell injections at overseas clinics.
• The Lancet Neurology: Multiple MS patients treated at unregulated overseas clinics experienced disease acceleration following unproven cellular interventions.
• Australia (TGA): Multiple prosecutions of clinics following patient deaths linked to fat-derived stem cell injections. [TGA Website]
• EMA: Repeated public warnings issued about unproven stem cell treatments noting post-treatment complications including infection, immune reactions, tumour growth, and death. [EMA on ATMPs]

“These are not rare theoretical risks. These are documented, reported cases of real patients who were harmed. When a patient comes to me for imaging after receiving an unregulated stem cell treatment, what I sometimes see on MRI is profoundly concerning — and entirely preventable.”
— Dr Prashant Sankaye, Consultant, LSRI London

Stem Cell Therapy Truth: The Global Regulatory Landscape

Stem Cell Therapy Truth in the United Kingdom

In the UK, cell-based products that are processed and used as medicines are regulated by the MHRA as advanced therapy medicinal products (ATMPs), and they need a marketing authorisation before they can be placed on the market¹⁵. Unlicensed ATMPs can be made available only through two routes: the ‘hospital exemption’, for products prepared on a non-routine basis and used in a hospital for a specific patient, and the ‘specials’ scheme. Under either route, the manufacturer needs an MHRA manufacturer’s licence¹⁵. The Human Tissue Authority is the licensing and inspection authority for tissues and cells, and the Human Fertilisation and Embryology Authority covers gametes and embryos¹⁵.

Stem Cell Therapy Truth in the European Union

In the EU, Regulation (EC) No 1394/2007 sets the overall framework for advanced therapy medicinal products, which are overseen by the European Medicines Agency¹⁶.

Stem Cell Therapy Truth in the United States

In the US, the FDA states that regenerative medicine products, including stem cell products, need FDA approval before they can be marketed to consumers, and that clinics often market them illegally as safe and effective³.

Global Picture

Countries including Mexico, Panama, Thailand, South Korea, Germany, and China have varying levels of regulation and are frequent stem cell tourism destinations. The ISSCR publishes international guidelines, last updated in 2021⁴.

“The regulatory system is trying. But it is fighting a multi-billion-dollar industry that operates faster than regulators can respond, across borders that national agencies cannot cross. That is precisely why patient education — not just regulation — is essential. An informed patient is their own best protection.”
— Dr Prashant Sankaye, London Sports and Rheumatology Imaging (LSRI)

What Legitimate Stem Cell Research Looks Like

A legitimate clinical trial will:

• Be registered on ClinicalTrials.gov, the ISRCTN registry, or the EU Clinical Trials Register
• Have received ethics committee approval
• Have a clearly defined patient population, treatment protocol, and endpoint
• Include fully informed consent, with patients aware they are in a research study
• Usually not charge participants for the experimental treatment⁴
• Have robust follow-up and adverse event reporting
• Publish results — positive or negative — in peer-reviewed journals

If someone is asking you to pay thousands of pounds to participate in what they call a “clinical trial” — that is not a legitimate clinical trial.

Genuine active trials advancing stem cell science include:

• MIST Trial (UK) — NHS-funded research into mesenchymal stem cells for treatment-resistant MS
• NEJM 2023 findings — haematopoietic stem cell transplantation in early relapsing MS
• Phase 1/2 trials at UCL, King’s College London, and Edinburgh for spinal cord injury
• iPS-derived cell therapies in early trials for macular degeneration (Japan) and Parkinson’s (USA)

Stem Cell Therapy for Spinal Conditions — A Specific Warning

At London Sports and Rheumatology Imaging (LSRI), Dr Prashant Sankaye and the clinical team will always discuss the full range of evidence-based treatment options with patients, including physiotherapy, guided injections, radiofrequency ablation, and surgical pathways where appropriate.

“Patients with back pain or degenerative spinal conditions are among the most aggressively targeted by stem cell clinic marketing. They have often tried everything else. Desperation is understandable — but it also makes patients targets. My responsibility is to give them honest information, not false hope.”
— Dr Prashant Sankaye, Consultant, LSRI London

Ten Questions Every Patient Must Ask

Before agreeing to any stem cell treatment, ask the following. Walk away if answers are evasive or incomplete.

1. Is this treatment approved by the MHRA, FDA, or EMA?
2. If not approved, is it part of a registered, ethics-approved clinical trial? What is the registry number?
3. What is the exact source of the stem cells? Autologous or allogeneic?
4. How are the cells processed, stored, and tested for viability and sterility?
5. What published, peer-reviewed evidence supports this for my specific condition?
6. What are the potential risks and documented adverse events?
7. What monitoring will take place after treatment?
8. Who do I contact if something goes wrong?
9. Is your clinic registered with the CQC?
10. Can I discuss this with my own NHS consultant before deciding?

Where to Get Help and Report Concerns

• MHRA (UK) — Report unregulated products: mhra.gov.uk
• ISSCR patient resources: isscr.org/patients
• NHS Stem Cell Transplant Information
• ClinicalTrials.gov — Find legitimate trials
• EU Clinical Trials Register
• EMA Website
• CQC — Check UK clinic registration

References

1. European Medicines Agency. EMA warns against using unproven cell-based therapies. EMA/CAT/94295/2020; 28 April 2020. https://www.ema.europa.eu/system/files/documents/public-statement/ema_communication_on_cell_based_therapies_en.pdf
2. European Medicines Agency. Holoclar: EPAR (medicine overview). https://www.ema.europa.eu/en/medicines/human/EPAR/holoclar
3. US Food and Drug Administration. Important patient and consumer information about regenerative medicine therapies. Content current as of 8 April 2024. https://www.fda.gov/vaccines-blood-biologics/consumers-biologics/important-patient-and-consumer-information-about-regenerative-medicine-therapies
4. Lovell-Badge R, Anthony E, Barker RA, et al. ISSCR Guidelines for Stem Cell Research and Clinical Translation: the 2021 update. Stem Cell Reports 2021;16(6):1398-1408. doi:10.1016/j.stemcr.2021.05.012
5. Turner L. The American stem cell sell in 2021: U.S. businesses selling unlicensed and unproven stem cell interventions. Cell Stem Cell 2021;28(11):1891-1895. doi:10.1016/j.stem.2021.10.008
6. Bauer G, Elsallab M, Abou-El-Enein M. Concise review: a comprehensive analysis of reported adverse events in patients receiving unproven stem cell-based interventions. Stem Cells Transl Med 2018;7(9):676-685. doi:10.1002/sctm.17-0282
7. Mautner K, Gottschalk M, Boden SD, et al. Cell-based versus corticosteroid injections for knee pain in osteoarthritis: a randomized phase 3 trial. Nat Med 2023;29(12):3120-3126. doi:10.1038/s41591-023-02632-w
8. Kim SH, Ha CW, Park YB, et al. Intra-articular injection of mesenchymal stem cells for clinical outcomes and cartilage repair in osteoarthritis of the knee: a meta-analysis of randomized controlled trials. Arch Orthop Trauma Surg 2019;139(7):971-980. doi:10.1007/s00402-019-03140-8
9. Kolasinski SL, Neogi T, Hochberg MC, et al. 2019 American College of Rheumatology/Arthritis Foundation guideline for the management of osteoarthritis of the hand, hip, and knee. Arthritis Care Res (Hoboken) 2020;72(2):149-162. doi:10.1002/acr.24131
10. American College of Rheumatology. 2026 update of the ACR recommendations for the management of osteoarthritis of the knee, hip, and hand: summary of recommendations (approved 8 September 2026). https://assets.contentstack.io/v3/assets/bltee37abb6b278ab2c/bltb3d12c34020da842/oa-guideline-summary-2026.pdf
11. Piuzzi NS, Ng M, Chughtai M, et al. The stem-cell market for the treatment of knee osteoarthritis: a patient perspective. J Knee Surg 2018;31(6):551-556. doi:10.1055/s-0037-1604443
12. Perkins KM, Spoto S, Rankin DA, et al. Notes from the field: infections after receipt of bacterially contaminated umbilical cord blood-derived stem cell products for other than hematopoietic or immunologic reconstitution, United States, 2018. MMWR Morb Mortal Wkly Rep 2018;67(50):1397-1399. doi:10.15585/mmwr.mm6750a5
13. Kuriyan AE, Albini TA, Townsend JH, et al. Vision loss after intravitreal injection of autologous “stem cells” for AMD. N Engl J Med 2017;376(11):1047-1053. doi:10.1056/NEJMoa1609583
14. Berkowitz AL, Miller MB, Mir SA, et al. Glioproliferative lesion of the spinal cord as a complication of “stem-cell tourism”. N Engl J Med 2016;375(2):196-198. doi:10.1056/NEJMc1600188
15. Medicines and Healthcare products Regulatory Agency. Advanced therapy medicinal products: regulation and licensing in UK. GOV.UK, updated 11 September 2026. https://www.gov.uk/guidance/advanced-therapy-medicinal-products-regulation-and-licensing
16. European Medicines Agency. Legal framework: advanced therapies. https://www.ema.europa.eu/en/human-regulatory-overview/advanced-therapy-medicinal-products-overview/legal-framework-advanced-therapies
17. Burt RK, Balabanov R, Burman J, et al. Effect of nonmyeloablative hematopoietic stem cell transplantation vs continued disease-modifying therapy on disease progression in patients with relapsing-remitting multiple sclerosis: a randomized clinical trial. JAMA 2019;321(2):165-174. doi:10.1001/jama.2018.18743
18. Brittain G, Petrie J, Duffy KEM, et al. Efficacy and safety of autologous haematopoietic stem cell transplantation versus alemtuzumab, ocrelizumab, ofatumumab or cladribine in relapsing remitting multiple sclerosis (StarMS): protocol for a randomised controlled trial. BMJ Open 2024;14(2):e083582. doi:10.1136/bmjopen-2023-083582
19. Mandai M, Watanabe A, Kurimoto Y, et al. Autologous induced stem-cell-derived retinal cells for macular degeneration. N Engl J Med 2017;376(11):1038-1046. doi:10.1056/NEJMoa1608368
20. Sawamoto N, Doi D, Nakanishi E, et al. Phase I/II trial of iPS-cell-derived dopaminergic cells for Parkinson’s disease. Nature 2025;641(8064):971-977. doi:10.1038/s41586-025-08700-0
21. Tabar V, Sarva H, Lozano AM, et al. Phase I trial of hES cell-derived dopaminergic neurons for Parkinson’s disease. Nature 2025;641(8064):978-983. doi:10.1038/s41586-025-08845-y