Tag

osteoarthritis
FTC Clinical Study Standards and Intraosseous Treatment

FTC Sets the Clinical Study Standards for Advertising Health-related Claims – Part Five

In the last post, I reviewed some of the issues and lessons from the Shapiro, et al. papers, as they related to doing higher level clinical studies with BMC. However, even their study didn’t meet the newly minted standard set by the FTC in the court Order issued last October. In that court Order, the...
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FTC Clinical Study Standards and Placebo Control

FTC Sets the Clinical Study Standards for Advertising Health-related Claims – Part Four

In the previous post, I had completed my review of the clinical findings published in a second paper by Shapiro, et al. confirming the utility of injecting saline into one OA-afflicted knee and BMC into the other OA-afflicted knee when treating patients with bilateral knee OA. Certainly, their approach is a novel way for treating...
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FTC Level 1 Clinical Study Standards and BMC

FTC Sets the Clinical Study Standards for Advertising Health-related Claims – Part Three

In the previous post, I had left you hanging on the follow-up publication by Shapiro, et al. that was published last year (2018). I wanted to review both papers in light of the recently established precedent obtained by the FTC in a Federal court Order issued last October, in which the FTC laid out the...
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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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Press Release Lipogems

Does Lipogems Want Orthopedic Surgeons to Think It’s Okay With the FDA to Use Fat-derived Fuzz Balls to Treat Orthopedic Conditions Like Knee Osteoarthritis? Part Two

Physicians in the regenerative medicine community were startled to read a press release issued on July 5th  by Lipogems, which seemed to suggest that the FDA had reversed or at least modified the prohibition on using adipose tissue to treat musculoskeletal conditions the Agency just released in a Guidance on Minimal Manipulation and Homologous Use last...
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Lipogems Press Release

Does Lipogems Want Orthopedic Surgeons to Think It’s Okay With the FDA to Use Fat-derived Fuzz Balls to Treat Orthopedic Conditions Like Knee Osteoarthritis? Part One

While I hadn’t seen anything new recently on the fuzz balling front (e.g., using mechanical methods to beat up adipose tissue for lipofilling procedures), imagine my surprise to see a press release dated July 5th with the following headline: FDA Clears The Way: Lipogems’ Receives FDA Clearance For Microfragmented Adipose Tissue System Utilizing Body’s Own...
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Treating Knee Osteoarthritis with Saline

Curious BMC and Saline Treatment Results for Patients With Bilateral Knee OA – Part Two

In the previous post, I had started my review of a paper published by Shapiro, et al., earlier this year (View Paper), in which they showed that treating a patient’s knee osteoarthritis with saline gave the same degree of pain relief as the use of bone marrow concentrate (BMC) in the other arthritic knee. Crazy,...
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BMC and Saline Treatment Results

Curious BMC and Saline Treatment Results for Patients With Bilateral Knee OA – Part One

In a paper published earlier this year (View Paper ), Shapiro, et al. reported on the results obtained from a clinical study in which a patient’s bone marrow was concentrated (creating BMC) and injected into one of the patient’s arthritic knees, with the other knee being injected with sterile saline. It turns out that the...
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