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"World’s First Approved Stem Cell Drug“ – May 2012 |
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Prochymal is approved to treat acute graft-vs-host disease, which is a complication that occurs after bone marrow transplant when the newly transplanted cells attack the host's body and cause life-threatening inflammation. Prochymal has been shown to control inflammation, stimulate regeneration, and decrease scarring. And yes, we're talking about live cells given to the patients intravenously. Several clinical trials are underway to see if Prochymal may be useful for treating other diseases. It's currently at Phase III (confirming efficacy) clinical trial for Crohn's disease (intestinal inflammation), at Phase II (determining efficacy) for type 1 diabetes (autoimmune disease), and at Phase I (determining safety) for preserving functional tissues after heart attacks.
It is essential mesenchymal stem cells (or bone marrow stem cells) obtained from the bone marrow of healthy adults that are purified and enriched in a lab. Mesenchymal stem cells were one of the first three adult stem cell populations identified; the others being hematopoietic stem cells (from blood), and neural stem cells (from the brain). Mesenchymal stem cells have long been known to reduce inflammation and suppress the immune response. They were also known to impart regenerative properties to damaged tissues. |
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| "Biosimilar Strategy & 351K", by D. A. Prasanna, at 'CPhI 2014, Paris 2014 |
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| “Stemcell to Market faster”, by D. A. Prasanna, at ‘IsraStem 2013’, Tel Aviv 2013 |
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| “Cell Therapy Trials - How CROs can impact trial outcome” by Dr. S. Kher at Stemcell Symposium, Tel Aviv 2013 |
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| “Speed to Dermatology Market and Clinical Endpoint studies“ by D.A. Prasanna & Nurjehan Jivani at BA&BE; conference, Mumbai, December 2012 |
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| "World’s First Approved Stem Cell Drug“ – May 2012 |
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| "Stem cell therapy clinical development capabilities“ by D A Prasanna, London, March 2010 |
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Read this whitepaper in PDF format  |
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