No Increased Cancer Risk from Your Autologous BMC Treatment

In the previous post, I commented on a paper recently published in the New England Journal of Medicine (NEJM) in which FDA personnel expressed their dissatisfaction with the lack of solid, Level 1 clinical trials for the use of stem cell therapies. Their concern quite naturally was on the lack of systematic recording of adverse...
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Cell Therapy

FDA’s Broadside Against Cell Therapy

The New England Journal of Medicine recently published an article written by folks at the FDA on science-based approaches to regulating the apparently confusing world of stem cell therapy (View Article). The focus of the article was on describing how the FDA views “stem-cell (sic) therapy”: “Often, these cells (whether derived from autologous or allogeneic...
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Changing Therapeutic Environment

Lessons for the FDA From Their Workshop on Draft Guidances – Part Two

After reviewing comments made by a considerable number of speakers at the September FDA Workshop on the four draft Guidances (Part One, Part Two, Part Three, Part Four), I switched over in the last post to what I thought were some of the critical issues and lessons the FDA might have learned from the testimony...
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Lessons for the FDA

Lessons for the FDA from their Workshop on Draft Guidances – Part One

Over the past four posts on the FDA Workshop on Draft Guidances (Part One, Part Two, Part Three, Part Four) I have reviewed comments from speakers at the Workshop on draft Guidances the FDA held this past September. With all due respect to the speakers and their heartfelt presentations, I see the FDA changing only...
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SVF Preparation

FDA Workshop on Draft Guidances – Part Four

Over the past three posts (Part One, Part Two, Part Three) I have highlighted several themes that have struck me as I review the presentations made at the FDA’s Workshop on the pending four draft Guidances. I have tried to handicap the likelihood that positions taken and relief requested by the speakers would sway the...
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Fat Tissue Issue

FDA Workshop on Draft Guidances – Part Three

There are three main themes that I have discussed so far that have stood out during my review of the two-day Workshop the FDA held on September 12 and 13. These themes are: Corporate needs should dictate the interpretation and application of the law that governs the use of patient-derived materials (including dead peoples’ parts...
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Safe Medical Environment

FDA Workshop on Draft Guidances – Part Two

Part One of my review of the speakers’ comments at the two-day stakeholder workshop the FDA held on September 12 and 13 to review four draft Guidances the Agency wants to finalize can be found here. The theme I had started with was the irony associated with certain speakers of large corporations wishing to cut...
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Draft Guidances

FDA Workshop on Draft Guidances – Part One

The FDA held a two-day stakeholder meeting on September 12 and 13 to review four draft Guidances the Agency wants to finalize. In this post, and several upcoming posts, I will review the comments of individuals who wanted to have their voices heard at the Workshop. The speakers were to comment on the following four...
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FDA Comes A Knockin'

When the FDA Comes A Knockin’

Previously in posts Hello From Greyledge and Is There a Way to Refine the Practice of Regenerative Medicine?, I introduced Greyledge Technologies and the service it provides to physicians and surgeons who have decided to use platelet rich plasma (PRP) and bone marrow concentrated cells (BMCC) either as adjunctive therapy during a surgical procedure or...
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Hello From Greyledge

I would like to take this opportunity to introduce myself to readers of the Blog on the Greyledge Technologies website. Some of you might be familiar with posts I wrote for a blog maintained by Celling Biosciences (Austin, TX). The change in websites reflects a change in my employment, as I now am Vice President...
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