Prochymal

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Remestemcel-L (100 million human mesenchymal stem cells in 15mL)

Available from:

CARSL Consulting

INN (International Name):

Remestemcel-L (100 million human mesenchymal stem cells in 15mL)

Dosage:

100 million cells in 15mL

Pharmaceutical form:

Solution for infusion

Composition:

Active: Remestemcel-L (100 million human mesenchymal stem cells in 15mL) Excipient: Albumin Dimethyl sulfoxide Plasma-Lyte A

Units in package:

Bag, plastic, EVA cell storage bag, 15 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Lonza Walkersville Inc

Therapeutic indications:

Prochymal is indicated for the rescue of patients NLT 6 months to 17 years of age with acute graft versus host disease (aGvHD), refractory to treatment with systemic corticosteroid therapy or other immunosuppressive agents. Prochymal use under these conditions is limited to Grades B to D of the disease.

Product summary:

Package - Contents - Shelf Life: Bag, plastic, EVA cell storage bag - 15 mL - 36 months from date of manufacture stored below -135°C 5 hours reconstituted stored at or below 25°C

Authorization date:

2011-06-07

Summary of Product characteristics

NEW ZEALAND DATA SHEET 

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Page 1 of 14 
NAME OF MEDICINE 
PROCHYMAL
®

PRESENTATION 
PROCHYMAL is a formulation
of _ex-vivo_ cultured adult human mesenchymal stem cells 
(hMSCs) intended for intravenous infusion.  PROCHYMAL is
provided as a frozen cell 
suspension in a cryogenic bag containing 100 x 10
6
 viable hMSCs per 15 mL.  The cells 
should be thawed and diluted to 2.5 x 10
6
 MSCs per mL prior to infusion. 
The mesenchymal stem cells are derived from the
bone marrow of unrelated and human 
leukocyte antigen (HLA)
–unmatched healthy adult donors.  Patient-specific blood
type or 
HLA matching is not required for the administration of hMSCs due
to the product’s low 
immunogenic profile. The
hMSCs are undifferentiated stem cells of mesodermal origin.  
They are primary cells that have
not been genetically manipulated or immortalized during the 
manufacturing
process.  The hMSCs are manufactured under aseptic conditions in
a 
process of isolation and culture expansion.  

TABLE 1:  HMSC KEY CHARACTERISTICS 
Macroscopic Appearance  
Opaque, off-white to pale amber in color 
Cellular Viability 
≥ 70%  
Identity (Cell Surface Markers)  

Positive Markers  
CD105 (Endoglin),  
CD 166 (Activated Leukocyte Adhesion 
Molecule)  
Negative Marker 
CD45 (Leukocyte common antigen) 
Potency 

TNF RI Expression 

≥ 108 pg/mL  
Inhibition of IL-
2Rα Expression   ≥ 30% inhibition  

The inactive
ingredients (excipients) are 10% dimethyl sulphoxide, 5% human serum 
albumin solution and up to 15 mL of Plasma-Lyte A. 
INDICATION 
Prochymal is indicated for the rescue
of patients 6 months to 17 years of age with acute graft 
versus host disease (aGvHD), refractory to treatment with
systemic corticosteroid therapy or 
other immunosuppressive
agents. Prochymal use under these�