Capitol Fax: Oppo Dump on Ted Gradel

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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.

* August of 2017…

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.

* December of 2017…

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.