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- Title
A phase II trial evaluating the safety and effectiveness of the AastromReplicell system for augmentation of low-dose blood stem cell transplantation.
- Authors
Pecora, A L; Stiff, P; LeMaistre, C F; Bayer, R; Bachier, C; Goldberg, S L; Parthasarathy, M; Jennis, A A; Smith, A K; Douville, J; Chen, B; Armstrong, R D; Mandalam, R K; Preti, R
- Abstract
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 μg/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 × 106/kg (range, 0.2–2.5) and 4.7 × 107 nucleated cells/kg (range, 1.98–8.7) of ex vivo expanded marrow. All patients recovered with normal blood counts and engrafted 500 neutrophils/μl and 20 000 platelets/μl 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. Bone Marrow Transplantation (2001) 28, 295–303.
- Subjects
STEM cell transplantation; HEMAPHERESIS; BONE marrow; BREAST
- Publication
Bone Marrow Transplantation, 2001, Vol 28, Issue 3, p295
- ISSN
0268-3369
- Publication type
Article
- DOI
10.1038/sj.bmt.1703137