stem cell injection infections

[nvrsumr]

Infections put 12 people in hospitals after they received unapproved stem cell products - CNN

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[Doctodd]

"products derived from umbilical cord blood"

products were not autologous...were from Liveyon and were recalled by FDA. Liveyon was buying from a lab, which they then immediately ceased buying from after FDA notice and switched to another lab, hardly interrupting their supply. Kinda like the Kenalog contaminations a few years ago.

 

[drusso]

Infections put 12 people in hospitals after they received unapproved stem cell products - CNN

Prepare for a big, big S*it Show coming out about this very issue very soon...huge class action level stuff...unqualified practitioners harming patients using Bogus Stem Cell products. Hopefully, this will shut-down the fly-by-night weekend course trained quacks. Medico-legal experts with content experience are standing by! Stop injecting stuff that you don't know about in patients and claiming miracle cures.

Contaminated Stem Cells

 

[nvrsumr]

I am pretty sure the baby is gonna be thrown out with the bath water.

I think bmac only has an fda reprieve til 2020.

 

[drusso]

I am pretty sure the baby is gonna be thrown out with the bath water.

I think bmac only has an fda reprieve til 2020.

It all depends how FDA weighs the evidence...

https://translational-medicine.biomedcentral.com/track/pdf/10.1186/s12967-018-1736-8

Bone Marrow Aspirate Concentrate Does Not Improve Osseous Integration of Osteochondral Allografts for the Treatment of Chondral Defects in the Knee... - PubMed - NCBI

Use of Bone Marrow Aspirate Concentrate with Acetabular Labral Repair for the Management of Chondrolabral Junction Breakdown. - PubMed - NCBI

A prospective evaluation of bone marrow aspirate concentrate and microfracture in the treatment of osteochondral lesions of the talus. - PubMed - NCBI

 

[lobelsteve]

It all depends how FDA weighs the evidence...

https://translational-medicine.biomedcentral.com/track/pdf/10.1186/s12967-018-1736-8

Bone Marrow Aspirate Concentrate Does Not Improve Osseous Integration of Osteochondral Allografts for the Treatment of Chondral Defects in the Knee... - PubMed - NCBI

Use of Bone Marrow Aspirate Concentrate with Acetabular Labral Repair for the Management of Chondrolabral Junction Breakdown. - PubMed - NCBI

A prospective evaluation of bone marrow aspirate concentrate and microfracture in the treatment of osteochondral lesions of the talus. - PubMed - NCBI

Funny. You think fda relies on evidence.

 

[BobBarker]

Funny. You think fda relies on evidence.

You are confusing me. I believe you were touting the FDA label of superiority for Nevro two days ago.

 

[Ducttape]

there are serious flaws in all 4 "studies" (the 3rd one is not a study but a position paper.)
centeno - everyone went for the injection, so not a crossover study. while he makes it, there can be no comparison to usual therapy, as noone ended up having usual therapy. no control group - ie all got injection. just one sentence by the investigator would skew all the data (ie. "gosh, you havent gotten the injection yet. no wonder you arent better.")

wang - probably best of the 3. but no control. was there any benefit to any of the patients at all? maybe BMAC didnt help, but... if the entire procedure wasnt beneficial at all, then BMAC shouldnt help. also, cohort study and the authors admit level 3 evidence...

the Murphy study was "prospective", but... he did surgery 1 way initially before 2012, then changed his entire practice approach to do surgery a different way after 2012. lends to bias and also speaks as to whether it wasnt the bone marrow but a change in his surgical technique (or the anesthesia, for example) that improved outcomes. maybe it was the fibrin glue and not the bone marrow that made the difference.....

 

[Doctodd]

Why isn’t the Hernigou bmac paper from a few years ago touted as strong evidence? The failures received a hip replacement, and there were few.

 

[lobelsteve]

You are confusing me. I believe you were touting the FDA label of superiority for Nevro two days ago.

Argument only if it supports my side.
See sufentanyl sublingual.

 

[drusso]

Why isn’t the Hernigou bmac paper from a few years ago touted as strong evidence? The failures received a hip replacement, and there were few.

hernigou bone marrow - PubMed - NCBI

Cell therapy versus simultaneous contralateral decompression in symptomatic corticosteroid osteonecrosis: a thirty year follow-up prospective rando... - PubMed - NCBI

The problem with Hernigou's work is that he's working in a socialized French medical system.

 

[drusso]

FDA sends warning to company for marketing dangerous unapproved stem cell products that put patients at risk and puts other stem cell firms, providers on notice

“The FDA is committed to advancing the field of cell-based regenerative medicine. We’re implementing new policies to make it more efficient to safely develop these promising new technologies. At the same time, we’re also focusing more resources on enforcement when we see companies skirt safety measures and put patients at risk. In this case, the company’s failure to put in place appropriate safeguards may have led to serious blood infections in patients,” said FDA Commissioner Scott Gottlieb, M.D."

 

[drusso]

12 People Hospitalized With Infections From Stem Cell Shots

“We’re going to be going in and inspecting more stem cell operators this year,” Dr. Scott Gottlieb, the agency’s commissioner, said in an email. “We’re focused on outfits that may be engaging in unsafe practices and haven’t been working with F.D.A. to come into compliance with the laws they’re subject to. Unfortunately, there are too many firms that fit this description.”

How confident are you in your tissue processing protocols, training, sterile technique, and understanding of cellular therapeutics? If you thought a visit from DEA for x-number issues/Suboxone was fun, wait until FDA inspectors show up in your clinic!

 

[nvrsumr]

No one understands cellular therapeutics as it relates to stem cell injections

 

[epidural man]

“The FDA is committed to advancing the field of cell-based regenerative medicine. "

Yeah...only if it makes their rich friends a lot of money (and I suspect several of the key FDA players are on the take as well).

 

[drusso]

Warning to clinicians and consumers! Report that some stem cell injections tied to bacterial infection outbreak - World Stem Cell Summit

 

[Crybaby]

This is what drives me nuts........
Dr. Brian Roadhouse (D.C)....... promising "pain free life" still trying to figure out who is doing the injections and what they are injecting. I had a crazy patient state they had spent 10k on a few injections from this place. Nurse Practitioner is on team and maybe out of state MD/DO????
Stem Cell Stem Therapy in Oklahoma | Cell Treatment Center in Tulsa, Oklahoma

 

[drusso]

This is what drives me nuts........
Dr. Brian Roadhouse (D.C)....... promising "pain free life" still trying to figure out who is doing the injections and what they are injecting. I had a crazy patient state they had spent 10k on a few injections from this place. Nurse Practitioner is on team and maybe out of state MD/DO????
Stem Cell Stem Therapy in Oklahoma | Cell Treatment Center in Tulsa, Oklahoma

Chiropractor Stem Cell Review: Which Clinics Are a Public Health Risk?

 

[SommeRiver]

Speaking of chiropractor...I got a Work Comp guy today with probably 50 pages of progress notes from his chiropractor...Here is a pic I took of the physical exam and subjective portions...Very informative...If you can't find extremely severe and intense humor in this picture you are on Seroquel.

Edit - Level of humor is outer space. No human can withstand this amount of stimulation.