The patellar tendon is one of the most active structures in physical activity. Its injury, especially in athletes, can become a prolonged, painful and frustrating obstacle. This was the case for a professional basketball player who, as part of a clinical trial authorized by the AEMPS, suffered for more than four years from chronic patellar tendon injury with partial rupture, which limited her performance and quality of life.
She was treated at the Institute for Tissue Regenerative Therapy (ITRT), where she received an advanced therapy medicinal product based on Cultured Mesenchymal Cells (CMC), individually authorized by the Spanish Agency of Medicines and Medical Devices (AEMPS).
This regulated procedure requires medical prescription and prior individualized assessment and is part of a clinically authorized program under medical supervision.
Information regarding her clinical progress is not disseminated for promotional purposes but rather for educational purposes, explaining the regulatory framework and the authorized applications of advanced therapy medicinal products.
Clinical trial: an athlete facing the challenge of a chronic injury
With an established professional basketball career, she sustained a partial rupture of the patellar tendon in her left knee that did not respond to standard treatments. For years she tried different approaches: physiotherapy, rest, anti-inflammatories, and interventional techniques, without achieving sustained improvement.
See also: How can the patellar tendon be regenerated with Cultured Mesenchymal Cells?
Aware of the functional limitation and emotional impact of not being able to play without pain, she decided to explore more advanced alternatives. She then came to ITRT, where she was offered participation in a personalized clinical protocol with a cell-based medicinal product individually authorized by the AEMPS.
A minimally invasive, authorized cell-based treatment
The procedure consisted of administering an advanced therapy medicinal product based on Cultured Mesenchymal Cells (CMC), obtained from the patient’s own bone marrow sample. These cells were:
- Isolated, cultured, and characterized under Good Manufacturing Practice (GMP) conditions.
- Selected for their anti-inflammatory, immunomodulatory, and biological repair properties.
- Injected under ultrasound guidance into the damaged area of the patellar tendon.
The cell-based medicinal product was manufactured individually under GMP conditions, with a dosage tailored to the clinical case according to AEMPS authorization.
The administration was performed in an outpatient setting under ultrasound guidance, without the need for general anesthesia.
Results: pathway back to sport
Following treatment, the athlete began an individualized rehabilitation program with the clinical team at ITRT. Pain gradually decreased, and mobility, strength, and neuromuscular control improved.
Functional tests and imaging confirmed clear tendon regeneration. Today, the athlete not only returned to pain-free training but has also embarked on a new sports career in weightlifting, earning medals at a major championship.
See also: Truths and myths about mesenchymal cells in tendon regeneration
Who is this treatment intended for?
The advanced therapy medicinal product with Cultured Mesenchymal Cells (CMC) must be prescribed for patients with chronic patellar tendinopathy (only a medical professional can diagnose and prescribe), who have not responded to conventional approaches such as physiotherapy, injections, shockwave therapy or functional rest.
Clinically, these advanced therapy medicinal products based on Cultured Mesenchymal Cells (CMC) are administered via ultrasound-guided injection into the injured tissue, as part of a minimally invasive, medically supervised procedure.
Their application requires medical prescription, GMP manufacturing, and individual authorization from the AEMPS.
Authorized clinical trials have observed a potential structural and functional improvement of the tendon in select patients with chronic patellar tendinopathy.
At ITRT we evaluate each case individually, but typical profiles that may benefit include:
- Athletes, both professional and amateur, with high functional demand.
- Patients with persistent patellar tendon pain (longer than 6 months) who have not improved with conventional treatments.
- Individuals seeking to avoid invasive surgery or who are not candidates for surgical intervention.
- Patients with imaging-confirmed degenerative injuries, such as partial tears, mucoid degeneration or loss of fibrillar alignment.
- Cases with significant impact on quality of life, such as difficulty climbing stairs, running or squatting.
This treatment is neither generic nor standardized: it requires a personalized clinical assessment, regulatory authorization and structured medical follow-up.
What makes this treatment different?
The approach used at ITRT is not a supplement nor a generalized treatment. It is an advanced cell-based medicinal product, developed in a cleanroom under regulated conditions, with quality control, personalized cell dosage and full traceability.
Key differentiating aspects include:
- Regulated manufacturing: produced as an advanced therapy medicinal product, in compliance with European SoHO (Substances of Human Origin) standards for human cell clinical use, and under the supervision of the AEMPS.
- Individual authorization: each application must be specifically and individually authorized for every patient by the AEMPS following clinical evaluation.
- Structured clinical follow-up: including periodic assessments, imaging studies and functional monitoring to ensure safety and traceability.
See also: ITRT proves for the first time that tendon can be regenerated with cultured mesenchymal stem cells
A real solution for patellar tendon injury
The clinical case was treated through a minimally invasive procedure individually authorized with the aim of promoting functional tendon recovery.
This type of approach, based on advanced therapy medicinal products, may be considered by medical professionals in selected cases that meet specific clinical criteria.
At ITRT we develop personalized cell-based medicinal products for cases like this professional athlete’s, with clinical evidence in patellar tendinopathy, osteoarthritis, disc disease, pseudoarthrosis and other complex musculoskeletal disorders.
ITRT: advanced therapy medicinal products with clinical and regulatory foundation
In a context where numerous unregulated cellular treatments proliferate, ITRT stands out for offering treatment based on an advanced therapy medicinal product in which structural regeneration has been observed in clinical trials authorized by the AEMPS.
These treatments are developed as advanced therapy medicinal products, manufactured with CMC under GMP conditions and individually authorized by the AEMPS.
All procedures at ITRT meet the criteria set by the European SoHO (Substances of Human Origin) framework and are supported by supervised clinical trials.
This rigor ensures:
- Biological safety and complete treatment traceability.
- Personalized cell dosage tailored to the specific injury.
- Structured clinical follow-up with continuous medical evaluation.
- Published evidence in scientific journals and international forums.
ITRT has extensive experience with individually authorized cell-based medicinal products, with more than 3,250 doses administered and approximately 1,900 patients treated, always within a strict clinical and regulatory framework.
Regulated approach using advanced therapy medicinal products for patellar tendon injuries
At the Institute for Tissue Regenerative Therapy (ITRT), clinical applications are developed using advanced therapy medicinal products based on Cultured Mesenchymal Cells (CMC), individually authorized by the Spanish Agency of Medicines and Medical Devices (AEMPS).
These medicinal products are strictly available under medical prescription and may be considered by healthcare professionals for patients with chronic patellar tendinopathy who have not responded to conventional therapies. Each case requires a specific clinical evaluation and the corresponding individual authorization from the AEMPS before administration.
NOTE: Advanced therapy medicinal products based on Cultured Mesenchymal Cells (CMC) are subject to medical prescription and require individual authorization from the Spanish Agency of Medicines and Medical Devices (AEMPS). The information presented here is for educational purposes and does not replace medical consultation or professional clinical advice.
