Brain tumor after infusion of fetal liver-derived cells in patient with diabetes

January 24, 2016

I’m continuing to document of all clinical cases reports on complications of cell therapy with focus on regenerative medicine. I’m trying to capture all published autopsy or pathology reports. I believe, such database will equip professionals with a knowledge and allow to avoid mistakes in future translation of cell therapies. Today, I’m going to highlight […]

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On conditional approval of cell therapy products

December 20, 2015

As you may know, about 2 years ago Japan has passed a new law for regulation of Regenerative Medicine. Under this law, the regulatory pathway for commercial cellular products is significantly accelerated by skipping of typical “Phase 3 trial” and allowance of marketing authorization after demonstration of safety and some (minimal) signs of efficacy (Phases […]

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Results of regenerative medicine clinical studies from 2014

March 1, 2015

Starting from 2014, I was trying to capture results of clinical studies in cell therapy. Today, I’d like to share some results of this attempt. I decided to narrow down my analysis to regenerative medicine, since most of cell-based therapies with published results belong to this category. Inclusion criteria and definitions Clinical study defined as […]

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Trends in cell therapy clinical trials 2011 – 2014

February 14, 2015

Post updated on Feb. 17, 2015 Today I’m sharing some of my data for the last 4 years. This is a snapshot of trends in cell therapy trials from 2011 to 2014. This year, I’m planning to make few posts on cell therapy trends. I’d like to analyze some trends in mesenchymal stromal cells, adipose […]

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Cell therapy clinical trials – 2014 Report

January 22, 2015

This is 2014 report of registered cell therapy clinical trials. Every year I give a snapshot of some tracked data, captured from international clinical trials databases. You can see previous annual reports here. Definitions and criteria I tracked clinical trials which fall in definition of cell therapy: administration of living cells in human with therapeutic […]

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Embryonic stem cells in cerebral palsy – results of clinical study from India

January 11, 2015

One clinical study, which was released 2 weeks before Christmas holidays captured my attention (but not attention of mass media). One of the most scandalous Indian “stem cell tourism” clinic Nutech Mediworld published(!) results of the study, which evaluates embryonic stem cell transplantation in children with cerebral palsy. Yes, you’re reading it correctly – embryonic […]

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Cell therapy clinical trials failures in 2014

January 4, 2015

Today, I’d like to highlight the most interesting, in my opinion, clinical trials failures, reported in 2014. As field is moving to efficacy (Phase 2) trials, we are starting to see more failures. In this overview, I’m going to focus on efficacy results. I hope we can learn a lot from these failures and avoid […]

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Top 10 cell therapy clinical studies in 2014

January 2, 2015

At the end of the year I analyze results of clinical studies in cell therapy. Today, I’d like to highlight 10 most significant, in my opinion, clinical studies with published results. Taking in account excellent safety profile of most cellular therapies, I was trying to focus on efficacy and long-term outcomes. Do cells really work? […]

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Cell therapy highlights from #ASH14

December 8, 2014

Annual 56th meeting of American Society for Hematology (ASH) is about to finish in San Francisco. I was following conference via twitter and I was amazed by stream of tweets – very good tweets, high value tweets, unpublished data tweets, 1 tweet per second! There was no “scientific tweets”, but almost all were “clinical”. Here, […]

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Some thoughts on results of NeoStem cardiac cell therapy trial

November 19, 2014

In the last two days I was involved in lively twitter discussions about the results of Phase 2 PreSERVE-AMI clinical trial, sponsored by NeoStem. Unfortunately, interpretation of results divided professionals for two camps – (1) trial is failed and (2) trial is successful. Why did it happen? Maybe the truth somewhere in the middle? I’d […]

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