Cultured mesenchymal cells (CMC) represent one of the greatest advances in advanced cell therapy medicines. These cells can differentiate into cartilage, bone, tendon, intervertebral disc, and salivary glands, and exert a powerful anti-inflammatory and immunomodulatory effect.
Most importantly, in clinical trials authorised by the AEMPS, CMC have shown not only their biological potential but their actual ability to achieve structural regeneration and healing of musculoskeletal injuries, allowing patients to regain function and quality of life.
At the ITRT, the use of cultured mesenchymal cells (CMC) is always carried out within the framework of clinical trials authorised by the Spanish Agency of Medicines and Medical Devices (AEMPS). The results have conclusively shown that this cell-based medicine achieves structural regeneration and tissue healing, leading to functional recovery for patients.
The efficacy of CMC is not a hypothesis but a clinical reality endorsed by the AEMPS and supported by publications in high-impact international journals such as The American Journal of Sports Medicine (AJSM) and Orthopaedic Journal of Sports Medicine (OJSM). This evidence reinforces the methodological rigour and scientific value of the results obtained.
With 23 clinical trials authorised by the AEMPS in conditions such as tendinopathies, osteoarthritis, discopathies, pseudoarthrosis, osteonecrosis, and xerostomia, ITRT has established itself as a global pioneer in the development of cell-based medicines manufactured in clean rooms.
1. Patellar tendon: regeneration without surgery
A randomised, double-blind clinical trial in patients with chronic patellar tendinopathy demonstrated that infiltration with CMC achieved complete tendon regeneration, pain relief, and a return to sports in just two months.
Patients treated with platelet-rich plasma (PRP), on the other hand, relapsed within six months, confirming the superiority of cell-based medicine over unregulated biological therapies.
This was the first clinical trial in the world to demonstrate structural regeneration of a tendon without surgery.
2. Knee osteoarthritis: joint preservation
A multicentre clinical trial in patients with knee osteoarthritis showed that allogeneic CMC significantly reduced pain and disability compared to the control group.
Magnetic resonance imaging confirmed regeneration of the articular cartilage, supporting their value as a medical alternative to preserve the joint and delay the need for prosthetic replacement.
3. Chronic low back pain: minimally invasive alternative
New clinical trials in development
ITRT is working on the development of new clinical trials with cultured mesenchymal cells (CMC) in two areas of major medical relevance:
- Longevity: aimed at assessing the potential of CMC to improve tissue function and quality of life during ageing.
- Infertility: focused on investigating the possible restoration of ovarian function using CMC.
These projects are currently in the development phase and are moving towards submission for authorisation by the AEMPS.
See also: Truths and myths about mesenchymal cells in tendon regeneration
Regulatory framework: advanced therapy medicinal products
Research with CMC at ITRT is conducted under strict regulatory oversight. Unlike other centres offering therapies without scientific endorsement, every clinical trial at the institute has the explicit authorisation of the AEMPS (Spanish Agency of Medicines and Medical Devices), ensuring both patient safety and the validity of the results.
Unlike unregulated approaches, ITRT develops advanced cell therapy medicinal products under the highest safety standards. These products are manufactured in accredited clean rooms, following European pharmaceutical quality requirements. Each administration is performed only after obtaining individual authorisation from the AEMPS, guaranteeing strict and personalised control for every patient.
The role of the AEMPS in clinical trials
The AEMPS is the competent authority in Spain for the supervision of advanced therapy medicinal products. Its role is to review and approve the protocols of each clinical trial, ensuring compliance with European standards of quality, safety, and efficacy. Thanks to this regulatory backing, patients treated with cultured mesenchymal cells at ITRT receive a biological treatment that combines innovation with maximum regulatory protection
Advanced therapy medicinal products
The cultured mesenchymal cells (CMC) used at ITRT are not experimental therapies but advanced therapy medicinal products, developed under European regulations and supervised by the AEMPS.
They are manufactured in accredited clean rooms, meeting pharmaceutical standards of quality, safety, and reproducibility. Each dose is produced with full traceability and standardised quality control, ensuring the medicine is consistent and reliable.
Unlike unregulated cell therapies, ITRT’s medicinal products are supported by scientific evidence published in international journals and by regulated clinical follow-up, positioning them as a real, safe, and clinically proven treatment option.
See also: What should you ask before undergoing stem cell treatment? A safety guide for patients
Distinctive value of cultured mesenchymal cells (CMC)
The key differentiator of CMC compared with unregulated therapies lies in their classification as advanced therapy medicinal products, produced under European pharmaceutical standards and with individual authorisation from the AEMPS.
Unlike experimental products without scientific validation, CMC have demonstrated in clinical trials their ability to regenerate damaged tissues and modulate inflammation, offering a homogeneous, reproducible, and safe treatment.
Advantages of treatment with cultured mesenchymal cells
Regeneration without surgery: CMC infiltrations allow tissue healing while avoiding invasive procedures.
Faster functional recovery: they promote natural repair and shorten rehabilitation time.
Precise outpatient application: performed under ultrasound or radiological guidance in the clinic.
Scientific and regulatory backing: clinical trials authorised by the AEMPS, with evidence published in international journals.
Pharmaceutical-grade safety: manufactured in clean rooms, with full traceability and quality control for each dose.
See also: Mesenchymal Cells in Tissue Regeneration: A Revolutionary Advancement in Regenerative Medicine
The future of mesenchymal cell therapies
Advances with cultured mesenchymal cells have transformed the management of joint, tendon, and disc injuries. Evidence from multiple clinical trials confirms that this biological treatment not only relieves symptoms but also promotes structural repair of damaged tissue.
The future lies in expanding the applications of advanced therapy medicinal products, with new studies underway exploring high-prevalence conditions. Under AEMPS supervision, the path is opening to safer, more effective, and personalised therapies capable of significantly improving patients’ quality of life.
If you wish to learn more about clinical trials with mesenchymal cells and assess whether this biological treatment may be suitable for your case, consult the ITRT medical team and receive a personalised evaluation.
