Stem cell therapies are generating increasing interest due to their regenerative potential. However, many of these applications are not authorised and lack clinical trials to support their effectiveness. This guide will help you assess whether a stem cell treatment is safe, legal and scientifically validated.
What are stem cell therapies and how do they work?
A stem cell therapy uses these cells — or their derivatives — to attempt to repair damaged tissues. But not all cell-based therapies lead to true regeneration. Only advanced therapy medicinal products (ATMPs) authorised by agencies such as the AEMPS (Spain) or the EMA (Europe) have demonstrated efficacy in clinical trials involving human patients.
What types of stem cells exist, and which ones are used at ITRT?
Cultured mesenchymal cells (CMC) are the most commonly used cell type in authorised regenerative medicine. Unlike same-day procedures, CMCs are expanded in the lab under GMP conditions until they reach an effective therapeutic dose. This process ensures their safety, viability and capacity to integrate into the tissue.
What conditions does ITRT treat with cell therapy?
At ITRT, we apply CMCs approved by the AEMPS to treat six main groups of musculoskeletal and glandular conditions:
- Tendinopathies: chronic injuries to the patellar, Achilles, hamstring and supraspinatus (shoulder) tendons.
- Osteoarthritis and cartilage injuries: including knee (gonarthrosis), hip (coxarthrosis), shoulder (omarthrosis), ankle, wrist and fingers.
- Discopathies: lumbar and cervical spine degeneration with persistent pain.
- Pseudarthrosis: non-healing bone fractures, especially in the tibia, femur and humerus.
- Osteonecrosis: involving the femoral head, humeral head or talus.
- Xerostomia: dysfunction of the salivary glands (parotid and submandibular).
How can you tell if a stem cell therapy is legal and safe?
For a cell therapy to be considered safe and legal, it must:
- Be approved by the AEMPS as an advanced therapy medicinal product (ATMP).
- Have demonstrated safety and efficacy in clinical trials.
- Be manufactured under GMP standards in a certified clean room.
- Be administered by a licensed professional with proper clinical follow-up.
What is a clinical trial and why is it essential?
A clinical trial is a regulated medical procedure designed to evaluate the safety, feasibility and effectiveness of a treatment in patients. It can only be conducted if it has been approved by an ethics committee and authorised by the AEMPS. It must also be registered on official platforms such as ClinicalTrials.gov.
It is the only legally recognised process to prove that a cell therapy works and can be offered with proper guarantees.
What should informed consent include?
The informed consent is a legal document that ensures you understand:
- Risks and benefits
- Available alternatives
- Duration and follow-up of the treatment
- Procedures and monitoring involved
It must be clear, comprehensive and approved by an ethics committee — especially if the treatment is experimental.
Guide to asking your doctor — and not being misled
Before starting any stem cell treatment, make sure you receive clear and documented answers. These 10 questions will help you verify whether the therapy is legal, safe and clinically supported:
1. Is what they’re going to inject an advanced therapy medicinal product (ATMP)?
An ATMP must be approved by the relevant health authorities and manufactured under controlled conditions. Not all products labelled “stem cells” meet this standard.
2. Has a clinical trial demonstrated its feasibility, safety and efficacy?
Insist that the treatment has undergone authorised clinical trials — not just preliminary studies or anecdotal reports.
3. Is it regulated by the AEMPS (Spanish Agency for Medicines and Medical Devices)?
Only products registered with the AEMPS offer legal guarantees, quality control and adverse event monitoring.
4. Was the product manufactured in a certified clean room with standard operating procedures (SOPs)?
A clean room is a highly controlled lab environment that prevents contamination. SOPs ensure every step is carried out safely and consistently.
5. Does this treatment have specific authorisation from the AEMPS?
Ask for the authorisation document or the clinical trial registration number.
6. Do you have the official authorisation to administer this treatment?
The doctor or clinic must be expressly authorised to apply advanced therapy medicinal products.
7. Does the product have an official information leaflet?
It should include:
- The dose to be administered
- Manufacturing and expiry dates
- Cell viability
- Confirmation that the product contains cultured mesenchymal cells, including their genetic characteristics
8. How many days pass between cell extraction and application?
The answer depends on the type of cells:
- Autologous cells (from the patient): must be cultured, which takes at least 21 days.
- Allogeneic cells (from a donor): may come from an ongoing culture (1–2 weeks) or from cryopreserved cells, which are prepared in 10 to 15 days.
If they tell you the cells will be administered on the same day they’re extracted — walk away. That is not a legally authorised medicinal product.
9. Will I receive clinical follow-up to assess pain improvement?
A legitimate treatment includes regular medical check-ups and standardised clinical scales to measure pain relief and functional progress.
10. Will imaging tests be used to evaluate regeneration?
MRI is the key tool to confirm whether the treatment has promoted regeneration of cartilage, tendon or other damaged tissues. Imaging follow-up must be part of the clinical protocol.
Warning signs: when to be suspicious
Be cautious if:
- No published scientific evidence is provided.
- The same treatment is offered for very different conditions.
- The origin and processing of the cells are not explained.
- There is no clinical protocol or ethical committee review.
- You’re told there are “no risks”.
- The cost is high without clear technical justification.
What risks can stem cell therapy involve?
Even authorised treatments may carry risks such as:
- Immune or inflammatory reactions
- Infections if GMP conditions are not met
- Lack of therapeutic effect
- Pain or discomfort at the application site
That’s why it is essential for the treatment to be legally authorised and clinically supervised.
Is it advisable to seek a second medical opinion?
Yes. Whenever you are offered a cell therapy, ask for an independent second opinion. Request the clinical documentation, treatment protocol, consent forms and all relevant information.
Where can you find reliable information?
Always demand clinical evidence and legal authorisation
Not all stem cell treatments are the same. Make sure to ask for:
- Evidence from clinical trials in humans
- Official authorisation from the AEMPS
- GMP-compliant manufacturing with full traceability
- Rigorous medical follow-up
At ITRT, all our therapies with cultured mesenchymal cells (CMC) meet these requirements and are approved for specific indications.
Do you have questions about a stem cell treatment?
At ITRT we are committed to a regenerative medicine based on science, legality, and patient safety. If you have questions about a diagnosis, a cell therapy, or would like to discuss your case with our medical team, please do not hesitate to contact us. We will be pleased to assist you in a clear, honest, and personalized manner.
