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Stem cell therapy shows early promise: Celgene

Bill Berkrot, Reuters, April 8, 2010

Crohn's disease is a favorite amongst mesenchymal stem cell development companies. This may be because on the one hand, this type of stem cell possesses anti-inflammatory properties, and on the other hand it has the potential to regenerate injured tissue. Additionally since the quality of life of patients with advanced Crohn's Disease is so poor, and current treatments are generally ineffective at addressing the root cause, that new treatments usually receive much support from regulatory agencies. Crohn's disease is characterized as a chronic inflammatory condition of the gastrointestinal tract. It is believed to affects almost one million people in the United States.

Today Celgene announced Phase I safety data on its placental mesenchymal stem cell product PDA-001 in a trial of 12 patients. The patients suffered from active moderate-to-severe Crohn's and were unresponsive to at least one prior conventional therapy. The treatment with stem cells comprised two infusions of PDA-001 one week apart. The patients were divided into 2 groups with 6 patients being administered a lower number of cells and six a higher number.

According to Celgene, "The study met its primary safety goal and demonstrated encouraging signs of clinical benefit, including clinical remission among four patients in the low dose group". Interestingly the company declined to speculate on why the lower number of cells elicited superior benefit. As an interesting aside, the company Osiris Therapeutic conducted a similar clinical trial in Crohn's Disease using stem cells derived not from placenta but from bone marrow sources.

The CEO of Celgene's Cellular Therapeutics unit, Dr. Robert Hariri stated "We are encouraged that in these patients with Crohn's disease our unique, placenta-derived therapies show signs of clinical benefit," he continued "We will continue to aggressively pursue the clinical development of this and other cellular therapies derived from what we see as one of the richest sources of uniquely functional and versatile cells."

The company anticipates moving into Phase II clinical trials not only in the area of Crohn's but also in other degenerative indications.

It is an interesting point that the cells were administered intravenously. There are some groups that believe stem cells only work if administered locally. This study suggests that the need for local injection may not be as important as some others believe. Additionally, since companies like Cellmedicine use various mesenchymal stem cell sources, the current results provide US-based scientific evidence supporting at least the rationale for this approach.

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