Standards

The ISSCR Standards Initiative was launched in 2021 as an international collaboration to strengthen the pipeline of research and applications to human health. The initiative published Standards for Human Stem Cell Use in Research in 2023; since being adopted by publications, institutions, and funders all over the world. Subsequent best practices are currently underway to help organizations navigate the regulatory landscape and process of clinical translation.

Standards for Human Stem Cell Use in Research

This document identifies quality standards and outlines basic core principles for the laboratory use of both tissue and pluripotent human stem cells and the in vitro model systems that rely on them. Overall, the emphasis of this document is creating a set of recommendations that, when taken together, establish the minimum characterization and reporting criteria for scientists, students, and technicians in basic research laboratories working with human stem cells.

Open-Access Downloads: FULL PDF | CHECKLIST PDF

Reporting Practices Checklist

This document identifies quality standards and outlines basic core principles for the laboratory use of both tissue and pluripotent human stem cells and the in vitro model systems that rely on them. Overall, the emphasis of this document is creating a set of recommendations that, when taken together, establish the minimum characterization and reporting criteria for scientists, students, and technicians in basic research laboratories working with human stem cells.

Open-Access Downloads: FILLABLE PDF | LAB POSTER

Standards Release Presentation

Highlights the release of the Standards, covering the scope and design of the initiative, lessons learned, and reporting requirements proposed. This session was recorded at the ISSCR Annual meeting in June, 2023.

Clinical Standards | Best Practices for the Development of PSC-Derived Cellular Therapies

Currently underway, this initiative will provide recommendations to facilitate and streamline the development of PSC-based cellular therapies regardless of regulatory jurisdiction. It will also provide detailed guidance at key product development pain points.

Working Groups and Focus Areas

An international group of leaders is currently developing this document. The Task Force is organized in working groups, led by the steering committee. Working group areas of focus includes:

  • Starting Materials

  • Banking

  • Ancillary Raw Materials and Devices

  • Regulatory

  • Drug Substance/Drug Product

  • Preclinical

  • Clinical Trials

The ISSCR Standards Initiative is made possible through contributions by: