ZEMCELPRO Dispersion for infusion Ref.[116219] Active ingredients:

Zemcelpro is a cryopreserved allogeneic hematopoietic stem and progenitor cell therapy containing two cell components, namely the expanded and unexpanded components, both derived from the same patient-specific umbilical cord blood unit (CBU).

The expanded component, referred to as dorocubicel which is the expanded CD34+ cells, is composed of the CD34+ fraction expanded ex-vivo in the presence of UM171.

The unexpanded component, referred to as unexpanded CD34- cells, is composed of the CD34-fraction from which the CD3+ cells are the active fraction.

Dorocubicel:

Each patient specific infusion bag of Zemcelpro contains a batch-dependent concentration of ex-vivo UM171 expanded CD34+ cells enriched population. The medicinal product is packaged in up to four infusion bags containing a dispersion for infusion of at least 0.23×10 6 viable CD34+ cells/mL suspended in a dimethyl sulfoxide (DMSO) solution.

Each infusion bag contains 20 mL dispersion for infusion.

Unexpanded CD34- cells:

Each patient-specific infusion bag contains a batch-dependent concentration of unexpanded CD34- cells. The medicinal product is packaged in four infusion bags containing a dispersion for infusion of at least 0.53×10 6 viable CD3+ cells/mL suspended in a dimethyl sulfoxide (DMSO) solution.

Each infusion bag contains 20 mL dispersion for infusion.

Quantitative information:

The quantitative information for each cell component of the medicinal product, including the batch dependent cell concentration and the number of infusion bags to be administered, is presented in the Release for infusion certificate (RfIC) accompanying the medicinal product for treatment. There is one RfIC for both cell components (see section 6).

Excipients with known effect:

This medicinal product contains a maximum of 477 mg sodium, 50 mg potassium, and 10% v/v DMSO per dose (see section 4.4).

For the full list of excipients, see section 6.1.