Category

Developments
Degenerative Disc Disease Treated with BMC

BMC as Degenerative Disc Disease Treatment – Part Four

The focus of the previous three posts (Part One, Part Two, and Part Three) has been on reviewing various aspects of a paper recently published on the three-year milestone data of a clinical study in which study subjects had their own BMC injected into a 1-level or 2-level degenerative disc pathology in an attempt to...
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Degenerative Disc Disease BMC Treatment

Three Year Follow Up on Using BMC to Treat Degenerative Disc Disease – Part Three

The topic of the last two posts (Part One and Part Two) has been the recent publication of three-year milestone data of a clinical study investigating the safety and feasibility of treating lumbar degenerative disc disease with an autologous injection of bone marrow concentrate (BMC).  The three-year milestone publication naturally follows the previous publication of...
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Degenerative Disc Disease BMC Treatment

Three Year Follow Up on Using BMC to Treat Degenerative Disc Disease – Part Two

I started reviewing in the last post details from the publication of the three-year milestone outcomes for a clinical study on treating degenerative disc disease with BMC. See the previous post for the link to the article in PubMed and my statement concerning the fact that I am a co-author on the paper, along with...
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BMC to Treat Disc Disease

Three Year Follow Up on Using BMC to Treat Degenerative Disc Disease – Part One

Sometimes it is good to get away on vacation, which is why I didn’t have a new post for the Blog last week. Not only did I get a break from the routine, but the god for post topics smiled on me and a paper entitled “Autologous bone marrow concentrate intradiscal injection for the treatment...
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Odd Comments About Regulatory Affairs

Catching Up on Regulatory Affairs – Part Two

In the last post, I had initiated a review of some really odd comments by an attorney, Mr. Richard Jaffe, on what he considers to be the free-for-all nature of a section of 21 CFR 1271—the law that controls the creation and use of human-derived materials, known as HCT/Ps, which was published in 2001 in...
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Regulatory Affairs

Catching Up on Regulatory Affairs – Part One

While I was settling in at my new job with Greyledge Technologies in Colorado, the FDA held a two-day stakeholder meeting to review four draft guidances the Agency wants to finalize. The four draft guidances are (in the order they were issued): Same Surgical Procedure Exception (October, 2014; source) Minimal Manipulation (December, 2014; source) Adipose...
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