Tag

bone marrow concentrate
BMC to Treat Orthopedic Conditions

Differences Between IV Infusion of BMC and Amniotic Fluid – Part Two

In the previous post, I had begun a review of the distinctions between the potential utility of an IV infusion of a patient’s bone marrow concentrate and the utter futility of using amniotic fluid products currently on the market to treat anything, whether by IV or site-specific injection. One of the issues I commented on...
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BMC Therapy vs Amniotic Fluid

Differences Between IV Infusion of BMC and Amniotic Fluid – Part One

No doubt some of you who regularly read my posts probably thought that I had lost my mind during the just completed set of three posts on considerations for using IV infusion with autologous BMC to boost up cellularity in a patient’s depleted bone marrow depots. I suspect you couldn’t believe that I would write posts...
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BMC via IV Therapy

Considerations On the Regulatory Status of IV Administration of BMC: A Useful Shot in the Arm? Part Three

Over the previous couple of posts, I have been reviewing the love/hate relationship the FDA seems to have with therapy provided by an IV route. They issued a blanket determination in the MM/HU Guidance that IV therapies of HCT/Ps would be considered risky and therefore physicians offering IV therapies of HCT/Ps would be more rapidly...
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BMC via IV Infusion

Considerations On the Regulatory Status of IV Administration of BMC: A Useful Shot in the Arm? Part Two

In the previous post, I reviewed the risk-based approach the FDA is taking in dealing with the free-for-all that currently exists in the world of regenerative medical therapies, like BMC and PRP. Actually, PRP and BMC don’t seem to raise red flags with the FDA, unlike amniotic fluid, cord blood-based products, fat-derived SVF in orthopedic...
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IV Administration BMC

Considerations On the Regulatory Status of IV Administration of BMC: A Useful Shot in the Arm? Part One

During a presentation at the recently concluded MedRebels conference, Dr. Don Buford indicated that there were no “homologus use” indications associated with IV infusion of autologous bone marrow concentrate (BMC). He made this point, in part, because of language the FDA has included in 21 CFR 1271.3 as follows: The following articles are not considered...
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Method of Ratios and PLT

Comments from Physicians on the Arthrex Angel Lemon/Lemonade Posts Highlight the Utility of the Method of Ratios – Part Two

In the previous post, I had shared a couple of comments from physicians (Drs. Sairam Atluri and Dr. Edward Marcheschi) that had been made on the trio of posts on the Arthrex Angel in which I concluded that the Arthrex Angel system was a lemon as a PRP/BMC processing technology. In exploring aspects of the...
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Arthrex Angel and Method of Ratios

Comments from Physicians on the Arthrex Angel Lemon/Lemonade Posts Highlight the Utility of the Method of Ratios – Part One

The posts that I write are available on the Greyledge website and are also distributed on LinkedIn. I would like to share a couple of LinkedIn comments from physicians who responded to the last three posts that have covered this question: Is the Arthrex Angel PRP/BMC processing system a lemon or has Arthrex’s marketing group made...
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Arthrex Angel System

Is the Arthrex Angel System a Lemon or Have They Made Lemonade? Part Three

In the previous two posts (Part One and Part Two), I have reviewed aspects of the performance of the Arthrex Angel system, which is being marketed to orthopedic surgeons to produce PRP and BMC for therapeutic treatments. I have covered the basics of the system and reviewed data from a publication that compared the cellular...
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Is the Arthrex Angel System a Lemon or Have They Made Lemonade? Part Two

In the previous post, I referred to comments that surgeons had shared with me at the AOSSM conference in early July about the Arthrex Angel system, which Arthrex markets to produce hematocrit (Hct)-specific PRP and BMC preparations. None of the surgeons I asked was able to provide any evidence that specific Hct levels were of...
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Arthrex Angel System Hct

Is the Arthrex Angel System a Lemon or Have They Made Lemonade? Part One

Recently, I staffed Greyledge’s booth at the AOSSM meeting held in San Diego, CA in early July. And I have to say it was an interesting experience due to the number of enquires I fielded from physicians who wanted to know if the Greyledge manual processing method in a biological safety cabinet with hemoanalysis of...
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