Whom should we blame for the absence of approved stem cell products in US?

September 14, 2016

Few months ago I was watching presentations from Bipartisan Policy Center on support of REGROW Act as alternative regulation for cell therapy, proposed to FDA. I was especially intrigued by presentation of Randal Mills – President and CEO of California Institute for Regenerative Medicine (CIRM). Here is a quote that I’d like to discuss today […]

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Why price for cell/ gene therapy products is so high?

September 6, 2016

The topic of pricing cell and gene therapies is very hot right now. The price tags for the most approved cell/gene therapy products are high and there is no one simple solution to address their reimbursement and adoption. The world’s most expensive drug is gene therapy drug Glybera, has captured a lot of attention in […]

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Is cell therapy failing commercialization in Europe?

August 19, 2016

Christopher Bravery – a consultant on advanced biologicals, has opened Cell Therapy Stream of the annual Bioprocessing Summit with worrisome note: “Half of approved cell and gene therapy products on European market eventually failed commercialization and were withdrawn“. Let’s look at it in details. Since introduction of regulation cell/ gene therapy as Advanced Therapy Medicinal […]

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FDA calls for collaboration on CAR T-cell therapies database

March 16, 2016

CAR T-cell therapy is disruptive technology on many levels. One of such levels is regulation. On the one hand regulators have not seen such impressive efficacy data for long time and it is very inspiring (FDA keeps awarding CAR T-cell developers with “Breakthrough Therapy” designation). On the other hand, high efficacy “comes with a high […]

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Spinal mass formation after auto- transplantation of olfactory cells in patients with spinal cord injury

February 13, 2016

The recent report, published in Acta Neuropathologica, describes 2 cases of spinal tissue mass formation after local transplantation of autologous olfactory mucosa in patients with spinal cord injury. Both patients underwent cell translplantation 7- and 5 years ago in Portugal as part of clinical trial. Patients were evaluated at University of Michigan Medical Center for […]

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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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