Production of ex vivo expanded hematopoietic cells and progenitors in a closed bioreactor, starting with a small volume marrow collection: A feasibility study in patients with poor-risk breast cancer and receiving high-doses of cyclophosphamide.
We report a clinical pilot study conducted in 6 women with poor-prognosis breast cancer. The goal was to evaluate the feasibility and safety of producing hematopoietic progenitors and cells from a small marrow sample, for clinical use after high-dose cyclophosphamide. A small volume marrow collection was obtained, using local anesthesia and conscious sedation, before the first of two chemotherapy cycles. Cells were cryopreserved, and later thawed to inoculate two Aastrom Biosciences Inc Replicell bioreactors, on time to reinfuse ex vivo expanded cells after the second chemotherapy cycle. Patients recovered neutrophils and platelets at similar times after the first and second chemotherapy cycles, and showed comparable clinical events. This pilot study prepares future randomized trials, designed to evaluate clinical benefits associated with the use of ex vivo expanded cells in the setting of multicycle high-dose chemotherapy.
Chabannon
C
C
Laboratoire de Biologie Cellulaire, Centre de Therapie Cellulaire, Institut Paoli-Calmettes, CRLCC Provence-Alpes-Cote d'Azur, 13273 Marseille cedex 9, France.
Blache
J L
JL
Sielleur
I
I
Douville
J
J
Faucher
C
C
Gravis
G
G
Arnoulet
C
C
Oziel-Taieb
S
S
Blaise
D
D
Novakovitch
G
G
Camerlo
J
J
Chabbert
I
I
Genre
D
D
Appel
M
M
Armstrong
D
D
Maraninchi
D
D
Viens
P
P
D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D019149:Bioreactors; D001856:Bone Marrow Examination; D001943:Breast Neoplasms / Q000188:drug therapy / Q000628:therapy*; D015925:Cryopreservation; D003520:Cyclophosphamide / Q000008:administration & dosage; D004305:Dose-Response Relationship, Drug; D004317:Doxorubicin / Q000008:administration & dosage; D005240:Feasibility Studies; D005260:Female; D006412:Hematopoietic Stem Cells; D006801:Humans; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies; D012307:Risk Factors; D013048:Specimen Handling / Q000379:methods*; D014407:Tumor Cells, Cultured
D004317:Doxorubicin; D003520:Cyclophosphamide