A Manually Curated Database on Clinical Studies Involving Cell Products Derived from Human Pluripotent Stem Cells

Area of Science:

• Regenerative Medicine
• Stem Cell Biology
• Clinical Trials

Background:

• The number of clinical studies utilizing human pluripotent stem cells (hPSCs) has significantly increased over the past five years.
• There is a growing concern regarding the proliferation of unregulated stem cell treatments globally.
• Establishing the safety and efficacy of novel cell therapies relies on regulated clinical testing, but information on hPSC studies is fragmented.

Purpose of the Study:

• To comprehensively analyze and catalogue global clinical studies involving human pluripotent stem cells (hPSCs).
• To address the scattered nature of reliable information on hPSC clinical trials.
• To create a centralized, publicly accessible database for tracking hPSC-based clinical studies.

Main Methods:

• Conducted a thorough analysis of multiple resources to identify clinical studies involving hPSCs.
• Collected data on the types of hPSCs used and the geographical distribution of these studies.
• Developed a publicly accessible database on the human pluripotent stem cell registry (https://hpscreg.eu) platform.

Main Results:

• Identified 54 clinical studies involving various types of hPSCs across ten countries.
• Observed that while human embryonic stem cell (hESC)-based studies form the majority, human induced pluripotent stem cell (hiPSC)-based studies show a stronger recent increase.
• Established a comprehensive and continuously updated overview of worldwide hPSC clinical studies.

Conclusions:

• A significant global increase in hPSC clinical research necessitates centralized tracking.
• The rise of hiPSCs in clinical studies warrants attention.
• The created database provides a vital resource for researchers, clinicians, and regulators monitoring hPSC therapeutic development.