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

Bone Marrow Transplantation volume 28, pages 295–303 (2001)Cite this article

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.

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Acknowledgements

Research support was provided by Aastrom Biosciences, Inc. The authors wish to acknowledge the work of Patricia Price, RN for her assistance in patient care and data management and Hillars Lazarus, MD for his thoughtful review of the manuscript.

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Authors and Affiliations

  1. Departments of Medicine, Hackensack University Medical Center, Hackensack, NJ, USA

    AL Pecora, SL Goldberg & AA Jennis

  2. Loyola University Medical School, Maywood Illinois, USA

    P Stiff, R Bayer, M Parthasarathy & B Chen

  3. Southwest Texas Cancer Institute, San Antonio, TX, USA

    CF LeMaistre & C Bachier

  4. Aastrom Biosciences, Ann Arbor, MI, USA

    AK Smith, J Douville, RD Armstrong & RK Mandalam

  5. Progenitor Cell Therapy, Hackensack, NJ, USA

    R Preti

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  1. AL Pecora
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Pecora, A., Stiff, P., LeMaistre, C. et al. A phase II trial evaluating the safety and effectiveness of the AastromReplicell system for augmentation of low-dose blood stem cell transplantation. Bone Marrow Transplant 28, 295–303 (2001). https://doi.org/10.1038/sj.bmt.1703137

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