Tissue Regenerative Therapy Institute (ITRT)

ITRT is a medical institute specialized in the development of advanced therapy medicinal products, created from cells obtained either from the patient or a donor, and cultured under controlled conditions for clinical use.

All procedures at ITRT are backed by authorized clinical trials and published scientific evidence. It operates under a fully regulated model, with cleanroom GMP manufacturing, individual authorization by the AEMPS, and full traceability from cell collection to clinical follow-up.

ITRT also has a cryopreservation system that allows CMCs to be stored under optimal conditions for later use, ensuring product stability and control for mid- or long-term planned treatments.

It is a medicinal product regulated by the Spanish Agency of Medicines and Medical Devices (AEMPS) and the European Medicines Agency (EMA), including cell-based, gene, or tissue-engineered therapies.

In the case of ITRT, these are advanced therapy medicinal products developed from Cultured Mesenchymal Cells (CMC), manufactured under GMP (Good Manufacturing Practice) standards in certified cleanrooms, and authorized individually for each patient.

They are progenitor cells derived from bone marrow, isolated and expanded over 21 days in controlled culture conditions. These cells are characterized, validated, and prepared for clinical use as advanced therapy medicinal products, with quality control and traceability in accordance with GMP standards.

CMC are cell-based medicines authorized by the AEMPS, with clinical evidence, GMP manufacturing, and regulated application.

In contrast, the term "stem cells" is ambiguous, unregulated, and often used to promote practices lacking legal and scientific basis. ITRT explicitly rejects this term due to its imprecision and use outside the authorized medical framework.

The safety and efficacy of ITRT’s medicinal products are supported by AEMPS-approved clinical trials, preclinical studies, scientific publications, and long-term clinical follow-up.

CMC developed by ITRT have been evaluated in authorized clinical trials for tendinopathies, osteoarthritis, discopathies, pseudoarthrosis, osteonecrosis, and xerostomia, showing evidence of structural regeneration and functional improvement.

Eligibility can only be determined following an individualized medical evaluation. The decision depends on specific clinical factors, imaging diagnosis, and medical history. Not all patients are candidates, and selection must be made by a specialized team.

Depending on the diagnosis, the medicine may be administered in a single dose or through a series of applications. The route of administration is determined based on the affected tissue and specific medical recommendation.

In the case of the medicinal products developed by ITRT, they are applied locally through minimally invasive procedures: intra-articular, intratendinous, intradiscal, or subchondral infiltration, depending on the clinical indication and authorized protocol.

Depending on the clinical indication and authorized protocol, autologous cells (from the same patient), allogeneic cells (from a compatible donor), or cryopreserved cells (previously stored at ultra-low temperatures) may be used. All cell types undergo quality control, cell characterization, and require individual authorization from AEMPS prior to clinical use.

AEMPS (Spanish Agency of Medicines and Medical Devices) is the authority responsible for individually authorizing each product, overseeing its manufacturing, ensuring safety, and controlling its clinical use in compliance with the current legal framework.

Yes, as long as there is a justified medical indication and the regulated procedure for individual authorization by AEMPS is followed. Access is restricted to medical teams with prior experience using the medicine in authorized clinical trials and must comply with all clinical, technical, and ethical criteria.

All ITRT medicinal products meet the quality controls required by GMP standards: sterility, viability, identity, potency, and absence of contaminants. In addition, structural and functional clinical follow-up is conducted over several years.

The entire process of medical evaluation, GMP manufacturing, and AEMPS authorization can be completed in approximately one week, depending on the cell type used and clinical logistics.

Treatment includes not only the administration of the medicine but also individualized clinical follow-up, which may extend from 2 to 5 years depending on the pathology. During this time, periodic structural and functional evaluations are performed, including imaging tests such as MRI, to assess clinical progress, stability of biological effects, and long-term safety.

ITRT develops only authorized medicinal products, with full traceability, clinical evidence, quality control, and full EMA/AEMPS regulatory compliance.

Unlike other unregulated offers, ITRT provides personalized, safe, and legally supervised medicine, explicitly rejecting the use of unauthorized products or misleading terms such as "stem cells."