Manufacturing Mesenchymal Stromal Cells for the Treatment of Graft-versus-Host Disease: A Survey among Centers Afﬁliated with the European Society for Blood and Marrow Transplantation

Biol Blood Marrow Transplant, 2018 · DOI: https://doi.org/10.1016/j.bbmt.2018.07.015 · Published: July 1, 2018

Immunology Regenerative Medicine & Stem Cells

Simple Explanation

Mesenchymal stromal cells (MSCs) have shown promise in controlling graft-versus-host disease (GvHD), but their effectiveness varies due to differences in how they are prepared. This study surveyed manufacturing protocols across European centers to understand the variability in MSC production. The survey revealed significant differences in tissue sources, culture methods, and product specifications, highlighting the need for harmonization to improve clinical trial outcomes.

Study Duration

Not specified

Participants

Data from 17 centers

Evidence Level

Not specified

Key Findings

1
Most centers use bone marrow as the source for MSCs, but there's a shift from fetal bovine serum to human platelet lysate as a medium supplement.
2
There is considerable variation in product specifications, especially in the markers used for phenotypical characterization.
3
A significant number of centers do not evaluate the presence of endotoxin in the final product formulation.

Research Summary

The study highlights significant variability in MSC manufacturing protocols across European centers, impacting the consistency of clinical products. Key variations were identified in tissue sources, culture supplements (FBS vs. hPL), and product specifications like marker expression thresholds. The findings emphasize the need for harmonization and standardization in MSC manufacturing to improve the interpretation of clinical results and therapeutic outcomes.

Practical Implications

Standardized Protocols

Development of standardized MSC manufacturing protocols can reduce variability and improve the reliability of clinical trial results.

Optimized Release Criteria

Establishment of more scientifically substantiated release criteria for MSC products, including relevant potency assays, is needed.

Enhanced Safety Measures

Ensuring consistent endotoxin testing across all manufacturing centers to enhance product safety.

Study Limitations

1
Limited sample size of 17 EBMT centers.
2
Reliance on self-reported data from questionnaires.
3
Lack of direct correlation between manufacturing variations and clinical outcomes.

Your Feedback

Was this summary helpful?

Back to Immunology