Bioengineering breakthroughs: The impact of stem cell models on advanced therapy medicinal product development

Table 2 Comparison between many aspects surrounding stem cells applied in advanced therapy medicinal products (ATMPs)

ATMPs	Degree of cell manipulation	Regulatory considerations	Clinical trial design	Surgical considerations
SCTMPs	Substantial manipulation	Often involves rigorous scrutiny of the manipulation processes and the resultant biological characteristics of the cells. Regulatory bodies require extensive data on safety and efficacy, particularly because these therapies may involve significant changes to the cells’ original functions. Clinical trials must demonstrate not only the safety of the therapy but also its therapeutic benefits in the intended patient population	Often include endpoints that assess both the manufacturing process and the therapeutic outcomes. This may involve feasibility studies to ensure that the cells can be successfully harvested, manipulated, and reintroduced to the patient. The complexity of these therapies necessitates close coordination between clinical teams and manufacturing facilities	The administration may require less invasive procedures, depending on the therapy. For instance, T-cell therapies can often be administered through infusion after manipulation outside the body
TEPs	Substantial manipulation	The focus is more on the engineering processes and the ability of the product to integrate and function in the body. The regulatory framework may emphasize the physical and biological properties of the engineered tissues, requiring evidence that they can effectively repair or replace damaged tissues	May be more focused on demonstrating the functional integration of the engineered tissues and their ability to restore tissue function. The design of these trials often involves assessing the physical and biological properties of the implanted tissues and their long-term performance in the body	Typically involves more complex surgical procedures for implantation, which can introduce additional risks associated with surgery, such as infection or complications from the surgical site. The success of these products is closely tied to the surgical technique and the patient’s ability to heal and integrate the new tissue

ATMP: Advanced therapy medicinal product; SCTMP: Somatic cell therapy medicinal product; TEP: Tissue-engineered product.