Occurrence and severity of adverse events after autologous hematopoietic progenitor cell infusion are related to the amount of granulocytes in the apheresis product.
BACKGROUND
Adverse events (AEs) after hematopoietic progenitor cell (HPC) infusion are rare but might be life-threatening. These reactions have traditionally been associated with the amount of infused cryoprotectant, but persistence of such events after dimethyl sulfoxide (DMSO) depletion has questioned this assumption.


METHODS
The incidence of AEs on a cohort of 460 patients (490 HPC infusions) undergoing autologous DMSO-reduced HPC transplantation was prospectively evaluated. HPCs were collected from adult patients with various hematologic or solid malignancies. After quality control (QC) on fresh apheresis products and subsequent cryopreservation, HPC grafts were thawed and washed at the cell therapy facility. QC was performed on each graft after washing, and clinical data were collected for each infusion.


RESULTS
AEs were reported in 66 cases (13.5%) and were graded according to the NCI-CTC scale from 1 to 4. Although none of the factors associated with patient characteristics or infusion procedure were different between the two groups (no AE vs. occurrence of AE), it was found that the absolute number of granulocytes measured before freezing was considerably higher in the AE group. Furthermore, within this group, there was a strong correlation between the amount of granulocytes and the grading of the reaction.


CONCLUSIONS
This survey demonstrates that AEs occurring in the setting of DMSO-reduced HPC grafts are directly related to the amount of granulocytes and thus emphasizes the need for high-quality apheresis products so as to improve the safety of HPC infusion.
Calmels
Boris
B
Centre de Thérapie Cellulaire et Génique, Institut Paoli-Calmettes, Centre Régional de Lutte Contre le Cancer Provence-Alpes-Côte d'Azur, 13273 Marseille Cedex 9, France. calmelsb@marseille.fnclcc.fr
Lemarié
Claude
C
Esterni
Benjamin
B
Malugani
Caroline
C
Charbonnier
Aude
A
Coso
Diane
D
de Colella
Jean-Marc Schiano
JM
Deconinck
Eric
E
Caillot
Denis
D
Viret
Frédéric
F
Ladaique
Patrick
P
Lapierre
Valérie
V
Chabannon
Christian
C
D000293:Adolescent; D000328:Adult; D000368:Aged; D001772:Blood Cell Count; D001781:Blood Component Removal; D003625:Data Collection; D004121:Dimethyl Sulfoxide; D005260:Female; D006098:Granulocytes / Q000166:cytology*; D018380:Hematopoietic Stem Cell Transplantation / Q000009:adverse effects*; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications / Q000628:therapy; D011446:Prospective Studies; D011786:Quality Control; D012720:Severity of Illness Index; D014182:Transplantation, Autologous
D004121:Dimethyl Sulfoxide