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* From a Daily Herald story about a recent 14th Congressional District Republican candidates’ forum…
Ted Gradel of Naperville faced a question about his involvement with the U.S. Stem Cell Clinic. The Florida-based company lost a federal lawsuit initiated by the Food and Drug Administration that accused the business of using unapproved stem cell treatments that caused three patients to lose their eyesight.
Gradel was an investor in the company and listed as its co-owner and managing officer.
Gradel said he invested in the company after finding success in using his own stem cells to treat pain in his joints. He said he is no longer involved with the company.
“They ran into some problems treating patients,” Gradel said. “I never had any involvement in health care decisions. The clinic is in Florida. I’ve never lived in Florida. There’s hundreds of companies I’ve invested in. I do my best to learn each time and move on.”
* Yeah, it was a bit more than that. From March of 2017…
U.S. Stem Cell Clinic is in the spotlight after three patients reportedly lost their eyesight following procedures here.
The Sunrise facility offers stem cell treatments for a range of diseases and chronic disorders and yet it has no medical facility license.
Here’s what you might not know: It doesn’t need one.
The facility falls under a regulatory loophole. Regulators with Florida’s Agency for Health Care Administration, which licenses health care facilities like hospitals and rehabilitation clinics, say they have no authority over stem cell operations. Neither does the Florida Department of Health, which only has regulatory power over personnel like licensed doctors and nurses working in these facilities.
* April of 2017…
Even though the clinical trial posted online specifically targeted eyes, Bade was offered another procedure for the same day: She could also have her knee injected with stem cells for $1,500 to ease pain.
Both of her eyes were injected, instead of just one. That put her at risk of blindness if the procedure went wrong.
Her injections were done by a nurse practitioner who was identified as a physician.
The U.S. Food and Drug Administration on Monday said U.S. Stem Cell Clinic in Sunrise, which had three patients suffer severe vision loss after stem cells were injected into their eyes, is violating federal regulations.
In a warning letter to the clinic’s chief scientific officer, Kristin Comella, the agency said U.S. Stem Cell does not have proper FDA permits to offer its experimental medical treatments. The clinic must respond to the FDA within 15 days or face regulatory action.
The clinic markets to patients nationwide who pay thousands of dollars to have stem cells harvested from their own body fat or bone marrow and reinjected into their bodies. The procedures have not been proven safe or effective by FDA standards.
Three women in their 70s and 80s with macular degeneration, all from outside South Florida, paid $5,000 each for stem cell injections in both eyes in 2015. They all had retinal detachments shortly after their procedures at U.S. Stem Cell. Two of the women sued for negligence, failure to warn, and allegations regarding how the product manufactured from their own bodies was defective. Both settled.
High-priced and largely unregulated clinics are drawing desperate people to Florida with promises of medical miracles, a South Florida Sun Sentinel investigation has found.
These businesses say stem cells harvested from patients’ belly fat, bone marrow or blood can be reinjected into their bodies to repair the damage inflicted by a staggering range of diseases, from Alzheimer’s to multiple sclerosis to macular degeneration.
None of these procedures are clinically proven to be safe and effective.
None are federally approved.
And patients are paying the price.
* May of 2018…
U.S. Stem Cell Clinic LLC, accused of injecting thousands of patients with unapproved stem cell treatments, is a target of an injunction request filed Wednesday in U.S. District Court for the Southern District of Florida, according to a news release by the FDA.
The injunction is also being sought against the company’s chief scientific officer, Kristin Comella, and its co-owner and managing officer, Theodore Gradel, “for marketing stem cell products to patients without FDA approval and while violating current good manufacturing practice requirements, including some that could impact the sterility of their products, putting patients at risk.” […]
U.S. Stem Cell Clinic LLC previously said it stopped its treatments for macular degeneration in June 2015 “after adverse effects were reported.” But in November, it asserted that its “in-clinic stem cell procedures should not be subject to the same regulatory process as off-the-shelf drug products.”
* June of 2019…
U.S. District Judge Ursula Ungaro of the Southern District of Florida granted the government’s motion for summary judgment against US Stem Cell Clinic LLC, of Weston, Florida, and US Stem Cell Inc., of Sunrise, Florida, and their Chief Scientific Officer Kristin Comella, Ph.D. The court held that the defendants in that case adulterated and misbranded a stem cell drug product made from a patient’s adipose tissue. […]
Following these steps, a U.S. court previously entered a consent decree of permanent injunction agreed to by the FDA and defendant Theodore Gradel, a former manager of US Stem Cell LLC that requires Mr. Gradel to notify the FDA if he intends to re-enter the biologics industry and to comply with any corrective actions ordered by the FDA.
posted by Rich Miller
Thursday, Feb 13, 20 @ 10:21 am
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Ouch. To quote the 80’s musical group INXS, sometimes you kick, sometimes you get kicked.
Comment by Ron Burgundy Thursday, Feb 13, 20 @ 10:27 am
So did Ted study biology at ND?
Comment by OneMan Thursday, Feb 13, 20 @ 10:28 am
A perfect Trump ally, cruel and dishonest.
Comment by Froganon Thursday, Feb 13, 20 @ 10:29 am
=== Following these steps, a U.S. court previously entered a consent decree of permanent injunction agreed to by the FDA and defendant Theodore Gradel, a former manager of US Stem Cell LLC that requires Mr. Gradel to notify the FDA if he intends to re-enter the biologics industry and to comply with any corrective actions ordered by the FDA.===
When you agree to a permanent injunction, that’s not a “whoopsies” kinda mistake, and when you have to notify them that you intend on veterinary the industry again, ‘cause they need to make sure you’re doing right… not a good thing for anyone.
Comment by Oswego Willy Thursday, Feb 13, 20 @ 10:33 am
I’m sure the FDA ban was merely a youthful indiscretion from eight months ago.
Comment by Ron Burgundy Thursday, Feb 13, 20 @ 10:39 am
===sometimes you kick, sometimes you get kicked===
I see what you did there.
Comment by Rich Miller Thursday, Feb 13, 20 @ 10:42 am
Gradel should’ve signed the company over to Barry Saacks.
Comment by Jocko Thursday, Feb 13, 20 @ 10:44 am
I see the issues with unregulated / unlicensed use / treatment. But stem cells are legitimately being investigated for various treatments.
Using stem cells to regrow knee cartiledge is a procedure that has been working its way to approval. Animal trials were so successful they quickly moved on to human trials. Right now it is classified as experimental. I recently had a conversation with my doctor about the procedure. There are drawbacks but a lot of success in treating knee joints.
Comment by RNUG Thursday, Feb 13, 20 @ 10:50 am
===“They ran into some problems treating patients,” Gradel said.===
By “they” he means “we” according to the FDA.
Another lying Republican. He’ll fit right in with the rest of them.
Comment by 47th Ward Thursday, Feb 13, 20 @ 10:56 am
“The clinic is in Florida. I never lived in Florida.”
Well then . . .
Comment by Henry Francis Thursday, Feb 13, 20 @ 10:56 am
I thought stem cells were on the pro-life no-no list. Conservatives seem to have no concerns over failed businesses, so unless someone ties the stem cells origin to fetal tissue, this is a non-issue for likely Gradel voters.
Comment by JSS Thursday, Feb 13, 20 @ 11:06 am
Gradel‘s response went wide Right
Comment by Oswego Willy Thursday, Feb 13, 20 @ 11:08 am
“I’m sure he’s learned from his mistake.” -Senator Susan Collins
Comment by PublicServant Thursday, Feb 13, 20 @ 11:51 am
Sounds like he’s trying to move the goal posts.
Comment by njt Thursday, Feb 13, 20 @ 12:06 pm
=Another lying Republican=
This isn’t a good look for Mr. Gradel. Of course, the person he’s looking to unseat made claims during her campaign that were less than accurate.
Does that make her another lying Democrat?
Comment by SSL Thursday, Feb 13, 20 @ 12:27 pm
===Does that make her===
Whataboutism. Right on cue.
Comment by 47th Ward Thursday, Feb 13, 20 @ 12:39 pm
The cowpire strikes back.
“Stem cell”
Lots of adult stem cell treatments in clinical trials. At facilities that have a license for that sort of thing
:):)
Comment by Fav human Thursday, Feb 13, 20 @ 12:57 pm
Gradel would get fewer votes in the general election than Oberweis would. Gradel’s greed caused grandma to go blind. Underwood and national Democrats would rightfully shred Gradel.
Plus Gradel is lying about his involvement. He was Managing Director and Co-Owner.
My question about Gradel’s commercials with Lou Holtz and contribution from the Governor of Arizona Ducey is did Ducey and Holtz not know about this scandal when they backed Gradel or did they know and not care?
Comment by Shiela Thursday, Feb 13, 20 @ 1:55 pm
There’s a little more to this story than what was shared here. Please see the full story from last fall:
http://mchenrycountyblog.com/2019/11/17/il-14-ted-the-truth-gradel-part-2-opportunities
Comment by John Lopez Thursday, Feb 13, 20 @ 3:16 pm
From the Washington Post on Gradel’s partner : “Although her long-standing title is chief scientific officer, Comella does not have a medical degree. She recently obtained her doctorate from a nonaccredited “virtual university” based in Panama. On its website, the Panama College of Cell Science offers a three-year PhD for $2,950 a year, or a discounted rate of $2,700 if students wire a lump sum in advance.”
If you’re a smart investor wouldn’t it have raised a red flag that your chief science officer didn’t have a medical degree and got her doctorate from an online non-accredited Panamanian “virtual university”
source: https://www.washingtonpost.com/national/health-science/this-clinics-experimental-stem-cell-treatment-blinded-patients-four-years-later-the-government-is-still-trying-to-shut-it-down/2019/04/03/432d6d04-ff2f-11e8-83c0-b06139e540e5_story.html
Comment by Hawkeye87 Thursday, Feb 13, 20 @ 3:34 pm
@John Lopez Co-owner, managing officer, FDA consent decree. Those seem to be the key words here. I’ve had several small investments in companies over the years but those three terms have never been uttered in relation to any one of them.
Comment by Pundent Thursday, Feb 13, 20 @ 6:49 pm
Pundent, I stand by the research finding and the titles are no more than perfunctory placeholder comparable to filling out an IL SOS corporate registration and given a title that has no meaning.
The state of Florida recorded both Gradel and Comella.
That is why the 10-K, something no one else researches, is crucial. Comella is in the 10K as a high ranking, and highly paid corporate officer.
Gradel is not named.
The evidence favors Gradel. There were some who tried to spread that he lived in Florida during this time, but that has been proven false, too.
Comment by John Lopez Thursday, Feb 13, 20 @ 7:27 pm
- John Lopez -
=== Following these steps, a U.S. court previously entered a consent decree of permanent injunction agreed to by the FDA and defendant Theodore Gradel, a former manager of US Stem Cell LLC that requires Mr. Gradel to notify the FDA if he intends to re-enter the biologics industry and to comply with any corrective actions ordered by the FDA.===
Is there “another” Mr. Gradel or…
Comment by Oswego Willy Thursday, Feb 13, 20 @ 7:31 pm
John Lopez - Rarely are consent decrees perfunctory. And if you’re argument is that Gradel didn’t realize that being a managing officer and co-owner could subject him to FDA scrutiny, then he’s probably lacking in some key areas of judgement regardless of what your 500 word essay might conclude. But I’m sure “read the 10-K” will make for a good stump speech.
Comment by Pundent Thursday, Feb 13, 20 @ 8:06 pm
- Prudent -
Top shelf. Good stuff.
===…consent decree of permanent injunction agreed to by the FDA and defendant Theodore Gradel…===
“Now, I don’t know what any of that means, but it sounds pretty bad.”
- Danny Kaffee, Navy Officer, Lawyer
Comment by Oswego Willy Thursday, Feb 13, 20 @ 8:13 pm