"Stem cell therapy clinical development capabilities“ by D A Prasanna, London, March 2010

Clinical trials on the use of stem cells are underway for a wide variety of conditions and there is an emphasis on the use of bone marrow, hematopoietic (mobilized and recovered in blood and umbilical cord blood) and mesenchymal stem cells. While safety has been consistently demonstrated, particularly with autologous transplants, sustained curative benefit has not been consistently obtained.

Allogenic transplants generally have major issues for continual immunosuppression to prevent rejection of grafted cells. In some cases, the benefit of cell therapy is through unidentified trophic effects of transient grafted cells. Nevertheless, progress for therapeutic benefit for patients is increasing and there is clear merit for using stem cells as delivery vehicles for correcting genetic mutations that cause severe disease phenotypes. Increasingly, new stem cell types are being explored and both neural and pluripotent stem cells (embryonic stem cells) are under study in early Phase I/II trials.

It is too early to predict the outcome of these trials at present but early observations of patients indicate that they do appear to be safe. Recent studies using induced pluripotent stem cells (iPSCs) have shown sizeable genetic and epigenetic abnormalities in these cells and there is now a clear need to determine the biological significance of those changes before iPSCs are taken to clinical trials. A strong indication of the confidence in the cell therapy field is the increasing participation of the large pharmaceutical companies in stem cell therapies.
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