Every year, people from different countries search for information about Teknon Hospital Barcelona because they have heard about advanced cell therapy medicinal products for tendon, bone, or cartilage injuries. Many are athletes with an injury that never fully heals. Others are patients with joint degeneration who have already tried physical therapy, injections, or surgery.
The Institute of Tissue Regenerative Therapy (ITRT) operates at Centro Médico Teknon in Barcelona. There, it works with cultured mesenchymal cells (CMC) for musculoskeletal conditions, always under authorization from the Spanish Agency of Medicines and Medical Devices (AEMPS).
Why regulation matters more than distance
When someone considers traveling to another country for a joint injury, the first questions are usually logistical: how much it costs, how long it takes, where to stay. However, the most important question is a different one: what type of product will be administered, and who oversees it?
Online, very different offerings coexist under similar names. In the United States, an analysis published in Cell Stem Cell identified at least 351 businesses marketing unapproved “stem cell” interventions at 570 clinics, and more than 300 of them advertised orthopedic uses (Turner and Knoepfler, Cell Stem Cell, 2016, PMID 27374789). That market targets exactly the kind of person reading this article, someone with joint pain or a sports injury who is looking for alternatives.
That is why, before considering any trip, it is important to distinguish between an unregulated procedure and an advanced cell therapy medicinal product. The difference is a scientific and regulatory matter, not a question of terminology.
What an advanced cell therapy medicinal product is and what the AEMPS requires
In the European Union, advanced therapy medicinal products are defined in Regulation (EC) No 1394/2007. In Spain, when these medicinal products are prepared on a non-industrial basis for a specific patient, Royal Decree 477/2014 applies.
Under this regulation, these are medicinal products prepared on an occasional basis, according to specific quality standards, and used in Spain within a hospital for “an individual medical prescription of a custom-made product intended for a single patient” (Royal Decree 477/2014, BOE-A-2014-6277).
In practice, this involves several requirements:
- AEMPS authorization, since use requires express authorization from the agency, which evaluates quality, safety, and clinical justification on a case-by-case basis.
- Manufacturing under Good Manufacturing Practice (GMP), since CMC are expanded in culture in a clean room, with quality and cell viability controls.
- Traceability, because the regulation requires that each product and its raw materials can be traced for 30 years after their expiration date.
- Pharmacovigilance, because the authorized center is responsible for reporting any suspected adverse reaction to the authorities.
CMC versus a same-day cell concentrate
Many international offerings are based on a cell concentrate that is obtained and applied in the same session. This type of preparation is minimally manipulated. It is not expanded in culture, does not selectively increase the mesenchymal cell population, is not manufactured under GMP, is not characterized, and does not require authorization as a medicinal product.
Cultured mesenchymal cells follow a different path. They undergo substantial manipulation through ex vivo expansion in a clean room, are adjusted to a precise and characterized cell dose, pass quality and viability controls, are traceable by batch, and are administered only with individual authorization from the AEMPS.
See also: Myths and facts about mesenchymal cells in structural tendon regeneration
Remote assessment: MRI and medical history
For someone living outside Spain, the first step is not to travel. No medical team can assess a musculoskeletal case without first reviewing the available clinical information.
At ITRT, this initial review is based on two documents:
- The MRI, which is the test that shows the condition of the tendon, cartilage, or bone, including whether there is a tear, a defect, wear, or an area that has not healed. It is best to send the complete study along with the radiologist’s report, not just the report.
- The medical history, which includes the diagnosis, how the injury has progressed, and previous treatments (physical therapy, injections, surgeries), with their dates. This information helps explain why the injury has not progressed as expected.
Documentation should be sent to [email protected]. The medical team reviews it and determines whether the case requires further testing or is not suitable for this approach. Not every injury needs the same type of intervention, and the assessment exists precisely to individualize that decision.
If your documentation is in a language other than Spanish or English, please say so when you send it.
A schedule agreed on an individual basis
One of the most common questions from international patients is how many times they will need to travel to Barcelona and how long they will need to stay. There is no single answer.
Because this is a custom-made medicinal product for a single patient, the schedule depends on each case: the type of injury, the medical assessment, the time required to manufacture the medicinal product in a clean room, and the AEMPS authorization. That is why visits are agreed on an individual basis between the patient, the medical team, and the clinic.
Be wary of any offer that proposes a fixed package with dates, accommodation, and a procedure before your MRI and medical history have been reviewed. A medicinal product subject to individual prescription cannot be planned like a standard product.
Athletes: season, club, and follow-up from home
Athletes, whether professional or high-level amateurs, have specific needs when considering international travel.
- Coordination with your medical team, since if you compete for a club or federation, it is advisable for your team physician or physical therapist to be involved from the start. They know how your injury has progressed and will be the ones supporting your recovery at home.
- Clear reports for your home physician, because clinical information must flow in both directions. The physician who follows you in your country needs to know which medicinal product was administered, under what authorization, and what follow-up has been planned.
- Regulated clinical follow-up, since progress in a tendon, cartilage, or bone injury is assessed using clinical criteria and imaging tests, usually with follow-up MRIs over time. Many of these check-ups can be done in your home country and then sent to the medical team in Barcelona.
- Realistic expectations, because the response to an advanced cell therapy medicinal product is not the same in every patient and depends on multiple factors: the injury, how long you have had it, age, or training load. No responsible professional can guarantee a timeline for returning to competition.
See also: Clinical trials with cultured mesenchymal cells at ITRT
How to get to Teknon Hospital Barcelona and other practical matters
Teknon Hospital Barcelona, officially known as Centro Médico Teknon, is located at Carrer de Vilana, 12, in the Sarrià-Sant Gervasi district, in the upper part of Barcelona. For those arriving from abroad, Josep Tarradellas Barcelona-El Prat Airport is the usual point of entry. It is best to check the center’s own website for up-to-date transportation and parking options.
Some practical recommendations for international patients:
- Bring a printed or digital copy of your MRI, reports, and previous treatments, even if you have already sent them.
- Let the team know in advance which language you prefer to communicate in.
- Consider traveling with a companion, especially if the visit includes a procedure.
- There are hotels in the neighborhoods near Teknon. Before booking, confirm the dates agreed with the medical team.
- Check with your insurance provider whether it covers medical care in Spain.
Frequently asked questions
Is a medicinal product with CMC the same as a “stem cell” injection?
No. Many “stem cell” offerings are based on minimally manipulated preparations, with no culture, no dose control, and no authorization as a medicinal product. Cultured mesenchymal cells (CMC) are manufactured in a clean room under GMP, with a characterized cell dose, traceability, and individual authorization from the AEMPS.
Is it the same as a same-day cell concentrate?
No. A same-day concentrate is obtained and applied in a single session, without expansion in culture or characterization. CMC undergo ex vivo expansion and quality and viability controls, and are administered as an advanced cell therapy medicinal product authorized by the AEMPS.
What is the difference between a regulated medicinal product and an unregulated procedure?
An advanced cell therapy medicinal product requires an individual medical prescription, manufacturing under Good Manufacturing Practice, traceability of each product, and pharmacovigilance, as established by Royal Decree 477/2014. An unregulated procedure is not subject to these controls.
What documentation is reviewed in a remote assessment?
The MRI, preferably the complete study along with the radiologist’s report, and the medical history with the diagnosis and previous treatments. These are sent to [email protected] for review by the medical team.
How many times will I need to travel to Barcelona?
It depends on each case. The number of visits and their schedule are agreed on an individual basis between the patient, the medical team, and the clinic, based on the assessment, the manufacturing of the medicinal product, and the AEMPS authorization.
Where is Teknon Hospital Barcelona?
At Carrer de Vilana, 12, in the Sarrià-Sant Gervasi district of Barcelona.
Legal notice
Advanced cell therapy medicinal products with cultured mesenchymal cells (CMC) require a medical prescription and individual authorization from the AEMPS. This content is for informational purposes only and is not a substitute for medical advice. Clinical outcomes depend on multiple factors and cannot be extrapolated from one patient to another.
