New minimum information standards for regenerative medicine

MIACARM, new standards made at CiRA, is expected to accelerate stem cell therapies

The global effort in stem cell-based regenerative medicines is expected to revolutionize patient treatment. However, the research leading to these new therapies are often based on different cell lines and cell assays. Ambiguous details about these differences could prevent reliable comparisons between methods, which could delay or stall innovation. This concern has only increased with new technologies that have expanded the information accumulated about a cell, for example, all the omics data now being collected. Accordingly, several consortia have developed a number of minimum information standards (MIS), which describe guidelines for how to report cellular data and are the basis for relevant databases and analysis tools. Several MIS have been made for different biologics. “MIACA was made for cellular assays,” explains CiRA Professor Wataru Fujibuchi, and provides a guideline for comparing different assays. However, MIACA is inadequate for regenerative medicine, which is why Fujibuchi led a team that now reports MIACARM. “MIACARM is based on MIACA,” he added.

There are more than 20 cell banks, registries and databases around the world that house information on human cells for clinical research. The goal of MIACARM is to provide a standardized system that allows easy exchange of information between these sites. In essence, MIACARM reorganizes MIACA into different modules and sections in order to reduce the time and effort for surveying details of the experiments like the assays, technologies and materials used. MIACARM was also designed to identify essential items that should be available in all banks for proper regulatory compliance in the manufacturing of regenerative medicines. These include details like the stem cell ID and agencies involved in the accreditation, which surprisingly are missing in many cases.

Fujibuchi is eager to use MIACARM to consolidate data from different banks. “The lack of standards for cell preparation and cell evaluation make it difficult to decide if a treatment is safe,” said Fujibuchi. MIS should make it easier to reproduce experiments and also have banks respond more robustly to new technologies that generate currently unavailable data.