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ProtheraCytes®

ProtheraCytes® is a fresh preparation of stem cells that has the potential for regeneration of various damaged tissues, including cardiac tissue. ProtheraCytes® is derived from CD34+ cells harvested from the peripheral blood of the patient after mobilization from the bone marrow, and the propietary expansion, purification, and formulation in a fresh cell suspension for injection.

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References

1 Krause, DS et al. (1996), CD34: structure, biology, and clinical utility. Blood 87:1–13 2 Leone AM et al. (2005), Mobilization of bone marrow-derived stem cells after myocardial infarction and left ventricular function. Eur Heart J. 26(12):1196-204.

Characteristics and potential of CD34+ stem cells

CD34+ stem cells are mainly located in the bone marrow1 and can be easily mobilized into the peripheral blood. Within the first week of an acute myocardial infarction (AMI), CD34+ cells are mobilized in increased numbers from the bone marrow into the peripheral blood. Clinical studies have shown that the concentration of CD34+ cells in the peripheral blood is significantly correlated to heart regeneration and functional improvement2. Unfortunately the number of naturally mobilized CD34+ cells is not sometimes not enough to have a sustained improvement and by administering more CD34+ cells, we can achieve long lasting improvement.

Mechanism of action

The underlying cardiac-repair mechanisms of ProtheraCytes® are multifaceted, combining a cell differentiation process and a paracrine effect. After AMI, CD34+ cells are mobilized from the bone marrow to the peripheral blood. We have shown that CD34+ cells secrete soluble paracrine factors such as growth factors and exosomes containing miRNAs that promote angiogenesis and revascularization of the ischemic tissue. CD34+ cells also differentiate into endothelial cells that can further revascularize the lesion.
StemXpand® V2 prototype with 5 incubators capable of manufacturing 5 patient therapies simultaneously.

Technology

CellProthera has developed a unique GMP-compliant manufacturing process as well as a proprietary automation technology for the expansion of CD34+ stem cells. The final cell product, labelled as ProtheraCytes®, has the potential for regeneration of various damaged tissues, including cardiac tissue. ProtheraCytes® is registered as an ATMP – Advanced Therapy Medicinal Product – within the classification of Tissue Engineered product by the European Medicine Agency (EMA).
CellProthera chose early on to invest in the development of an automation technology to guarantee a consistent level of quality across multiple production sites, for each patient and at an affordable price. Leading a consortium of five industrial partners and a research institute, together with the support of BPI France, CellProthera has developed a technology platform comprising of an automated device StemXpand® and a single-use kit StemPack®, compliant with GMP guidelines.