Stem Cell Week

Recent findings in stem cell research described by B.E. Butterworth and colleagues

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"The donors remain cancer free and the causes of these DCL are unknown. Stem cells must repopulate the bone marrow and then give rise to all hematopoietic cells for the rest of the transplant recipient's life. No procedure is acceptable that might introduce precancerous or cancerous mutations in cells performing such a critical function. Medical disposable sets consisting of bags, tubing sets and freezing containers are used to collect, purify and store stem cells. Sterilization of disposables with ethylene oxide is widespread, even though those sets unavoidably retain residual amounts of ethylene oxide which is a potent, direct-acting mutagen and clastogen that has been demonstrated to induce hematopoietic cancer in mice, rats and human beings. Potential exposure levels to ethylene oxide during processing under proposed US FDA guidelines for residual ethylene oxide would be biologically active and present a significant risk factor for DCL. For direct-acting mutagens, there is no recognized 'no effect' dose using currently accepted cancer risk assessment models," wrote B.E. Butterworth and colleagues, .

The researchers concluded: "The safety concerns with ethylene oxide can be eliminated by the use of alternative technologies including electron beam, gamma irradiation, or steam for the sterilization of all products used for stem cell processing and storage."

Butterworth and colleagues published their study in Regulatory Toxicology and Pharmacology (Exposure of hematopoietic stem cells to ethylene oxide during processing represents a potential carcinogenic risk for transplant recipients. Regulatory Toxicology and Pharmacology, 2007;49(3):149-53).

For additional information, contact B.E. Butterworth, Butterworth Consulting, 4820 Regalwood Dr., Raleigh, NC 27613 USA..

The publisher of the journal Regulatory Toxicology and Pharmacology can be contacted at: Academic Press Inc. Elsevier Science, 525 B St., Ste. 1900, San Diego, CA 92101-4495, USA.

Keywords: United States, Raleigh, Blood Transfusion, Bone Marrow, Cancer, Cell Transplantation, Cord Blood, Drugs, Hematology, Hematopoietic, Leukemia, Medical Device, Oncology, Pharmaceuticals, Pharmacology, Stem Cell Research, Therapies, Toxicology, Transfusion Medicine.

This article was prepared by Stem Cell Week editors from staff and other reports. Copyright 2008, Stem Cell Week via NewsRx.com.