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Development of a potency assay for CD34+ cell-based therapy
Anne Aries1, Christine Vignon2, Céline Zanetti1
1Institut de Recherche en Hématologie et Transplantation, Hôpital du Hasenrain, 87 Avenue d'Altkirch, Mulhouse, France.
Scientific Reports
|November 11, 2023
Summary
Expanded autologous CD34+ cells (ProtheraCytes) show potential for myocardial regeneration. In vitro studies confirmed their angiogenic and regenerative properties, with VEGF concentration identified as a reliable potency assay for clinical use.
Area of Science:
- Cardiovascular biology
- Regenerative medicine
- Cell therapy
Background:
- Intracardiac delivery of autologous CD34+ cells is safe and improves outcomes post-acute myocardial infarction (AMI).
- A Phase I/IIb study is evaluating expanded autologous CD34+ cells (ProtheraCytes) for intramyocardial injection in post-AMI patients.
Purpose of the Study:
- To characterize ProtheraCytes in vitro for potency assay development.
- To assess growth factor and exosome secretion, gene expression, cell surface markers, differentiation, and angiogenic potential.
Main Methods:
- In vitro characterization of ProtheraCytes clinical batches.
- Analysis of secreted factors (VEGF, exosomes with miRNAs).
- Assessment of cell surface markers, differentiation capacity, and angiogenic activity.
Main Results:
- ProtheraCytes secrete VEGF, with concentration correlating to CD34+ cell expansion.
- Secreted exosomes contain miRNAs involved in angiogenesis, anti-apoptosis, antifibrosis, and myocardial regeneration.
- ProtheraCytes exhibit in vitro angiogenic activity and differentiate into endothelial cells.
Conclusions:
- Vascular Endothelial Growth Factor (VEGF) concentration is a practical, reliable, and consistent measure for ProtheraCytes potency.
- In vitro data support the therapeutic potential of ProtheraCytes for myocardial repair post-AMI.
