Journal Article

A phase II trial evaluating the safety and effectiveness of the AastromReplicell system for augmentation of low-dose blood stem cell transplantation

Pecora, AL, Mandalam, RK, Parthasarathy, M, Jennis, AA, Douville, J, Goldberg, SL, LeMaistre, CF, Armstrong, RD, Preti, R, Bachier, C, Stiff, P, Chen, B, Bayer, R, Smith, AK

2001

Overview

To reduce the number of apheresis procedures and maintain the usual rate of hematopoietic recovery in patients treated with high-dose chemotherapy, we studied the effect of adding a small volume of ex vivo expanded bone marrow to low doses of CD34(+) blood stem cells. Thirty-four patients with breast cancer received G-CSF (10 microg/kg/day) priming followed by a limited volume (50-100 ml) bone marrow aspiration and standard 10-liter aphereses. Marrow was expanded ex vivo using the AastromReplicell system and infused along with low doses of blood-derived CD34(+) cells, collected in one apheresis. Thirty-one evaluable patients received a median CD34(+) blood stem cell dose of 0.7 x 10(6)/kg (range, 0.2-2.5) and 4.7 x 10(7) nucleated cells/kg (range, 1.98-8.7) of ex vivo expanded marrow. All patients recovered with normal blood counts and engrafted 500 neutrophils/microl and 20 000 platelets/microl in a median of 10 and 13 days, respectively. Multivariate analysis revealed that, in addition to CD34(+) lineage negative cell quantity, the quantity of stromal progenitors contained in the ex vivo expanded product correlated with engraftment outcome (r = 0.551, P = 0.004). Our results indicate that ex vivo expanded bone marrow is capable of facilitating engraftment when combined with low doses of mobilized blood derived CD34(+) cells.

• Publisher: Nature Publishing Group
• Subject: Adult / Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy / Antigens, CD34 - analysis / Apheresis / Biological and medical sciences / Blood / Bone marrow / Bone Marrow Cells - cytology / Bone marrow transplantation / Bone Marrow Transplantation - methods / Bone Marrow Transplantation - standards / Bone marrow, stem cells transplantation. Graft versus host reaction / Breast cancer / Breast Neoplasms - therapy / CD34 antigen / Cell Culture Techniques - instrumentation / Cell Culture Techniques - methods / Chemotherapy / Cytapheresis - methods / Cytapheresis - standards / Dosage / Engraftment / Equipment Safety - methods / Equipment Safety - standards / Female / Graft Survival / Granulocyte colony-stimulating factor / Hematopoietic Stem Cell Transplantation - adverse effects / Hematopoietic Stem Cell Transplantation - methods / Hematopoietic Stem Cell Transplantation - standards / Hematopoietic stem cells / Hemopoiesis / Humans / Leukocytes (neutrophilic) / Medical sciences / Middle Aged / Multivariate Analysis / Platelets / Priming / Progenitor cells / Stem cell transplantation / Stem cells / Stromal Cells - cytology / Stromal Cells - transplantation / Transfusions. Complications. Transfusion reactions. Cell and gene therapy / Transplantation / Treatment Outcome