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Interview with StemCells Inc. leadership on hot topics

GregSchiffman

StemCells Inc. is a top biotech company developing stem cell-based therapies. They have a deep pipeline that includes already ongoing trials for a variety of diseases. I invited company leadership to do an interview and they graciously accepted. Below is the interview with CFO Greg Schiffman (picture at left from LinkedIn) including what I thought …

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Advanced Cell Technology (ACT) Revs Up Pre-Clinical Studies for MS

advanced-cell-technology

There is more good news from leading stem cell biotech Advanced Cell Technology (ACT) on preclinical rodent studies using stem cells to treat mice with an MS-like condition. They published a new paper in the journal Stem Cell Reports entitled “Human ESC-Derived MSCs Outperform Bone Marrow MSCs in the Treatment of an EAE Model of …

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Court in Regenerative Sciences Case: Propagated Stem Cells Are Drugs

A long-standing debate in the commercial stem cell arena has focused on whether stem cells grown in a lab prior to clinical use as a transplantation product are biological drugs subject to full FDA vetting. The alternative view has been that such stem cell products are not drugs, but rather are simple human cellular and …

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Book Excerpt: Stem Cells for Alzheimer’s Disease–Are We There yet?

Below is an excerpt focused on Alzheimer’s Disease from my new book on stem cells. Stem Cells: An Insider’s Guide, which is targeted to a broad audience of people interested in stem cells. Alzheimer’s Disease (AD) is one of the most devastating illnesses. It destroys the brain, which shrinks over time (see image from Wikipedia …

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Short-term safety of lab-grown stem cells for arthritis: encouraging, but key caveats

A new paper suggests a hopeful short-term safety profile of laboratory-grown stem cells for treatment of arthritis, but there are some important limitations to the study too. A debate continues to bubble over whether to classify laboratory-propagated stem cells as biological drugs. A persistent issue has been whether the growth of stem cells in culture …

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Time to bone up on homologous use in the stem cell field

What does homologous use mean? Navigating the arena of clinical use of a biologic such as stem cells or differentiated cells made from stem cells can be challenging. There are many important issues including what defines “minimal manipulation” of biologics such as cells. One particular issue that is critically important and has drawn less attention …

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Celltex FDA FOIA letter #2: no safety concerns with our stem cells, which really are not drugs

A FOIA request that I made with the FDA in mid-December 2012 has at long last revealed  letters from Celltex  to the FDA that previously were not in the public domain. The reason for the FOIA and for these blog posts is to shed some light on important issues that particularly relate to patient safety. I …

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Jeong Chan Ra Arrest: Can RNL Bio (알앤엘바이오) Survive?

Ra

Over at Health in the Global Village, Leigh Turner yesterday published an excellent piece updating us all on the latest news on Korean stem cell company RNL BIo (알앤엘바이오) and its leader, Dr. Jeong Chan Ra (라정찬 ). Addition: The story was reported in several Korean news outlets including Hani here.  A video here by MBC News of Korea, one …

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