FDA cracks down on clinics marketing unapproved stem cell therapies

The US Food and Drug Administration ...

Posted: May 10, 2018 7:12 PM
Updated: May 10, 2018 7:12 PM

The US Food and Drug Administration filed two federal complaints Wednesday seeking to permanently ban two clinics from marketing stem cell products without regulatory approval and accusing them of "significant deviations" from good manufacturing practice requirements.

Permanent injunctions are sought for US Stem Cell Clinic LLC of Sunrise, Florida, and California Stem Cell Treatment Center Inc., which includes the Cell Surgical Network Corp., in Rancho Mirage and Beverly Hills. The FDA also cited officers of both companies in its legal actions.

FDA seeks to permanently ban two stem cell clinics from marketing treatments

Manufacturing violations could impact the sterility of products, FDA says

Manufacturing violations could impact the sterility of products used at both companies, placing patients at risk, the FDA said.

"In the two cases filed today, the clinics and their leadership have continued to disregard the law and more importantly, patient safety," FDA Commissioner Dr. Scott Gottlieb said in a statement. "We cannot allow unproven products that exploit the hope of patients and their loved ones."

Stem cells are sometimes called the body's master cells, as they develop into blood, brain, bones and organs and have the potential to repair, restore, replace and regenerate cells. Scientists believe it is possible these cells can be used to treat many medical conditions and diseases. The FDA has not approved any stem cell-based products for use as treatments other than blood-forming stem cells derived from umbilical cord blood, according to the agency's website.

In August, the FDA posted a warning letter after an inspection of US Stem Cell Clinic. The agency said, that, though it had never reviewed or approved any of its biological products, the clinic was creating stem cells from body fat and administering them intravenously or directly into the spinal cords of patients to treat Parkinson's disease, amyotrophic lateral sclerosis, chronic obstructive pulmonary disease and other serious conditions.

FDA investigators also documented evidence that the clinic failed to establish and follow appropriate procedures to prevent microbiological contamination of products, which puts patients at risk for infections. US Stem Cell Clinic also refused to allow FDA investigators entry, except by appointment, and denied access to employees, the agency alleged. Refusing to permit entry or an FDA inspection is a violation of federal law.

US Stem Cell said in a statement Wednesday that it intended to "vigorously defend" itself with respect to the FDA's lawsuit. Chief Science Officer Kristin Comella said, "It is my life's work to pioneer regenerative medicine and educate the public about its healing potential. ... No government agency should deprive individuals of their right to harness the cells that exist in their body."

The company did not comment on FDA's assertion that it violated good manufacturing practice requirements.

Also in August, the FDA seized from California Stem Cell Treatment Centers five vials of vaccinia virus vaccine (live) belonging to Stemimmune Inc. of San Diego. Each of the vials originally contained 100 doses of the vaccine, which is usually reserved for people at high risk of smallpox (such as military personnel), yet one vial was partially used. ?

After being mixed with stem cells, the unapproved concoction was injected directly into the tumors of cancer patients at California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, the FDA said. Co-founder Dr. Elliot B. Lander said the centers were participating in studies that had been approved by international review boards.

At the time, the FDA said it had "serious concerns" about how StemImmune obtained the vaccine, which is not commercially available. Because its investigation is ongoing, the FDA is unable to comment on this aspect of the case, said FDA spokeswoman Lyndsay Meyer.

California Stem Cell Treatment Center Inc. and StemImmune did not immediately respond to a request for comment on the FDA's latest actions.

Gottlieb said, "Cell-based regenerative medicine holds significant medical opportunity, but we've also seen some bad actors ... peddle unapproved treatments that put patients' health at risk. In some instances, patients have suffered serious and permanent harm after receiving these unapproved products."

Mississippi Coronavirus Cases

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Cases: 148387

Reported Deaths: 3769
CountyCasesDeaths
DeSoto9874101
Hinds9821198
Harrison6982110
Jackson6218119
Rankin5417102
Lee498495
Madison4711106
Forrest375086
Jones352488
Lauderdale3412145
Lafayette319749
Washington3153107
Lamar286349
Oktibbeha243562
Bolivar240884
Lowndes232864
Neshoba2189118
Panola218849
Marshall211950
Leflore203490
Pontotoc199128
Monroe196077
Sunflower191055
Lincoln187865
Warren174157
Tate166951
Union165325
Pike160958
Copiah160440
Yazoo152939
Scott151829
Itawamba151134
Coahoma149543
Pearl River149467
Alcorn148228
Simpson146353
Prentiss143730
Adams139250
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Leake133243
Holmes127861
Tippah123730
George123524
Covington120938
Winston120024
Hancock117639
Wayne116923
Marion114846
Attala111234
Tishomingo108742
Chickasaw106932
Newton104229
Tallahatchie96727
Clay89927
Clarke89153
Jasper81722
Walthall76028
Stone75214
Calhoun73713
Montgomery72825
Carroll71415
Lawrence70714
Yalobusha70527
Smith70316
Noxubee70017
Perry65826
Tunica60219
Greene59722
Claiborne57916
Jefferson Davis56017
Humphreys53119
Amite52714
Benton49017
Quitman4846
Webster42314
Kemper42118
Wilkinson38722
Jefferson34711
Franklin3345
Choctaw3157
Sharkey30817
Issaquena1144
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Alabama Coronavirus Cases

Cases: 241957

Reported Deaths: 3572
CountyCasesDeaths
Jefferson31809500
Mobile19651361
Madison12964148
Tuscaloosa12946154
Montgomery12263236
Shelby1016177
Baldwin857698
Lee771866
Morgan648050
Calhoun6215119
Etowah618266
Marshall618255
Houston522438
DeKalb480436
Cullman433442
Limestone418645
St. Clair413655
Elmore403764
Lauderdale396754
Walker3620111
Talladega347954
Jackson311723
Colbert306042
Blount287940
Autauga270442
Franklin250233
Coffee242015
Dale231754
Dallas225232
Russell22123
Chilton220638
Covington218034
Escambia197931
Chambers176450
Tallapoosa175491
Pike158114
Clarke157619
Marion137136
Winston131123
Lawrence126336
Pickens121618
Geneva12108
Marengo120224
Barbour117010
Bibb117017
Butler115341
Randolph101921
Cherokee101024
Hale96031
Clay91024
Washington90719
Fayette89316
Henry8526
Lowndes79429
Monroe78311
Cleburne76914
Macon73022
Crenshaw70930
Bullock69419
Conecuh68314
Perry6836
Lamar6678
Wilcox63118
Sumter57522
Greene42318
Choctaw42113
Coosa3414
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