Perspective from developers: Tissue-engineered products for skin wound healing

Area of Science:

• Regenerative Medicine
• Biotechnology
• Dermatology

Background:

• Tissue-engineered products (TEPs) represent a significant advancement in developmental medicine, analogous to the impact of monoclonal antibodies and recombinant cytokines decades prior.
• The field of TEPs for skin wound healing is rapidly expanding, offering promising novel therapeutic strategies for conditions with limited effective treatments.

Purpose of the Study:

• To outline the process of translating laboratory-developed TEPs for skin wound healing into clinical practice.
• To provide historical context, review approved therapies, and detail the regulatory landscape in Brazil for TEPs.
• To offer insights into quality testing, nonclinical validation, and regulatory considerations based on Brazilian (RENETA) and international (ICH, ISO) standards.

Main Methods:

• Comprehensive review of scientific literature and regulatory guidelines.
• Analysis of historical perspectives and currently approved TEP therapies for skin wound healing.
• Examination of quality, biosafety, nonclinical, and clinical trial requirements, including pharmacovigilance.

Main Results:

• The review details the multifaceted approach required for TEP development, integrating scientific and industrial viewpoints.
• It highlights essential guidelines for quality control and biosafety, crucial for regulatory approval.
• The analysis covers nonclinical viability, clinical trial design, and the importance of real-world data for pharmacovigilance.

Conclusions:

• The development of TEPs for skin wound healing is a dynamic and promising field with significant therapeutic potential.
• Navigating the regulatory framework, particularly in Brazil, is critical for successful clinical translation.
• A robust understanding of quality, safety, and efficacy standards is essential for advancing TEPs from bench to bedside.