Perinatal derivatives application: Identifying possibilities for clinical use.

Area of Science:

• Regenerative Medicine
• Stem Cell Biology
• Clinical Trials

Background:

• Perinatal derivatives (PnD) are increasingly recognized as a valuable source of multipotent stromal cells, stem cells, and biological matrices.
• These cells hold significant potential for developing novel regenerative therapies for diseases with limited treatment options.

Purpose of the Study:

• To provide a comprehensive overview of the state-of-the-art in clinical applications of PnD.
• To analyze 10 years of clinical trial data involving PnD usage, including commercialized products.
• To propose a standardized approach for clinical trial preparation and registration for PnD.

Main Methods:

• Compilation and analysis of 10 years of clinical trial data related to PnD.
• Focused evaluation on aspects like treated disorders, manipulation, administration route, dosage, and frequency.
• Development of a questionnaire to guide new PnD clinical trial preparation.

Main Results:

• Observed correlations between PnD products, specific conditions, administration methods, and dosages, indicating a consolidated clinical practice.
• Identified limitations in accessing regulatory information from the compiled data.
• The compiled database will be made publicly available.

Conclusions:

• PnD represent a consolidated and effective therapeutic option with potential to become a new standard of care.
• Standardized protocols for PnD clinical trial preparation and registration are proposed.
• Highlights the potential of PnD in advancing regenerative medicine and clinical practice.