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

Pecora, AL; Stiff, P. J.; LeMaistre, C.F.; Bayer, Robert; Bachier, Carlos; Goldberg, SL; Parthasarathy, Mala; Jennis, A; Smith, A. K.; Douville, Judith; Chen, B; Armstrong, R.D.; Mandalam, RK; Preti, Robert A.

doi:10.1038/sj.bmt.1703137

Cited by 33 publications

(18 citation statements)

References 31 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Recent laboratory and clinical trials have demonstrated more effective approaches in eliminating contaminating malignant cells from marrow and blood stem cell products using chemical agents, monoclonal antibodies, CD34 + affinity devices, ex vivo expansion, and other techniques [20,[28][29][30][31][32][33][34]. Thus, the importance of blood stem cell product contamination may increase with improvements in eradication of in vivo residual disease in patients with metastatic breast cancer treated with high-dose chemotherapy [30].…”

Section: B B and M Tmentioning

confidence: 99%

Breast cancer cell contamination of blood stem cell products in patients with metastatic breast cancer: Predictors and clinical relevance

Pecora

Lazarus

Jennis

et al. 2002

Biology of Blood and Marrow Transplantation

View full text Add to dashboard Cite

The incidence and clinical relevance of tumor cells contaminating the stem cell products of patients with advanced breast cancer treated with high-dose chemotherapy is uncertain because prior studies used small sample sizes and lacked standardization of the immunocytochemistry (ICC) detection method used. We evaluated blood stem cell and bone marrow samples obtained from 535 women with metastatic breast cancer who received high-dose chemotherapy and unmanipulated mobilized blood stem cell support. Of the patients tested, 20.6% and 26.3% had blood stem cell and bone marrow contamination, respectively. Blood stem cell contamination was significantly more frequent in patients with marrow involvement than in patients without marrow involvement (35% versus 18.4%, respectively; P = .009). In fact, according to multivariate analysis results, marrow involvement was the only significant predictor for blood stem cell product contamination. Patients without marrow involvement who had fewer apheresis procedures were also observed to have a significantly lower incidence rate of blood stem cell contamination than patients who had more procedures (P < or = .008), and patients who received combined chemotherapy and cytokine mobilization therapy had less contamination than patients who received cytokine alone (P = .0001). Combined mobilization therapy appears to be associated with a lower incidence of contamination as a result of fewer apheresis procedures rather than through an antitumor effect of chemotherapy (P < or = .001). Patients with ICC-negative blood stem cell products had significantly longer progression-free survival (PFS) and overall survival (OS) than did patients with ICC-positive blood stem cell products (median PFS, 401 versus 291 days, respectively, P = .007; median OS, 1060 versus 697 days, P = .009) . However, multivariate analysis did not reveal any significant independent predictors of survival outcomes. Thus, further study is needed to determine if contaminating tumor cells in the stem cell products of breast cancer patients ever directly impact survival outcomes or are only indicative of residual in vivo disease in high-dose chemotherapy recipients.

show abstract

Section: B B and M Tmentioning

confidence: 99%

Breast cancer cell contamination of blood stem cell products in patients with metastatic breast cancer: Predictors and clinical relevance

Pecora

Lazarus

Jennis

et al. 2002

Biology of Blood and Marrow Transplantation

View full text Add to dashboard Cite

show abstract

“…The proprietary Replicell technology developed by Aastrom Biosciences Inc. was shown to be feasible but not definitively effective in enhancing myeloid, erythroid or platelet engraftment in the clinical setting (Jaroscak et al, 2003, Pecora et al, 2001. The system uses stromal co-cultures while also providing a continuous supply of culture medium containing fetal calf serum, horse serum, PIXY321 (a GM-CSF/IL-3 fusion protein), flt3 (FL) and erythropoietin (EPO) (Stiff et al, 2000).…”

Section: Preclinical and Clinical Studies Using Cord Blood Hscmentioning

confidence: 99%

Exploring the Human Term Placenta as a Novel Source for Stem Cells and their Application in the Clinic

Heazlewood¹,

Cook²,

Ilić³

et al. 2012

Recent Advances in Research on the Human Placenta

View full text Add to dashboard Cite

“…This technology results in significant expansion of primary human cells 20,21 and has previously demonstrated clinical success in the expansion of bone marrow and blood cells for replenishment of hematopoietic cells after treatment of various blood dyscrasias. [22][23][24][25] Additionally, results of recent in vitro and in vivo studies have generated interest in using this process to produce cells for bone tissue regeneration. 26 The hypothesis underlying the current study is that BRCs have osteogenic and angiogenic potential that could manifest in their ability to regenerate bone and vascular tissue in a clinical craniofacial application.…”

Section: Introductionmentioning

confidence: 99%

Angiogenic and Osteogenic Potential of Bone Repair Cells for Craniofacial Regeneration

Kaigler

Pagni

Park

et al. 2010

Tissue Engineering Part A

View full text Add to dashboard Cite

There has been increased interest in the therapeutic potential of bone marrow derived cells for tissue engineering applications. Bone repair cells (BRCs) represent a unique cell population generated via an ex vivo, closed-system, automated cell expansion process, to drive the propagation of highly osteogenic and angiogenic cells for bone engineering applications. The aims of this study were (1) to evaluate the in vitro osteogenic and angiogenic potential of BRCs, and (2) to evaluate the bone and vascular regenerative potential of BRCs in a craniofacial clinical application. BRCs were produced from bone marrow aspirates and their phenotypes and multipotent potential characterized. Flow cytometry demonstrated that BRCs were enriched for mesenchymal and vascular phenotypes. Alkaline phosphatase and von Kossa staining were performed to assess osteogenic differentiation, and reverse transcriptase-polymerase chain reaction was used to determine the expression levels of bone specific factors. Angiogenic differentiation was determined through in vitro formation of tube-like structures and fluorescent labeling of endothelial cells. Finally, 6 weeks after BRC transplantation into a human jawbone defect, a biopsy of the regenerated site revealed highly vascularized, mineralized bone tissue formation. Taken together, these data provide evidence for the multilineage and clinical potential of BRCs for craniofacial regeneration.

show abstract

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

Cited by 33 publications

References 31 publications

Breast cancer cell contamination of blood stem cell products in patients with metastatic breast cancer: Predictors and clinical relevance

Breast cancer cell contamination of blood stem cell products in patients with metastatic breast cancer: Predictors and clinical relevance

Exploring the Human Term Placenta as a Novel Source for Stem Cells and their Application in the Clinic

Angiogenic and Osteogenic Potential of Bone Repair Cells for Craniofacial Regeneration

Contact Info

Product

Resources

About