By RON HURTIBISE
SOUTH FLORIDA SUN SENTINEL
SEP 11, 2019
https://www.sun-sentinel.com/business/fl-bz-us-stem-cell-destruction-postponed-pending-appeal-20190911-eq4in32unfae5e2hvjv2lqdn24-story.html
U.S. Stem Cell destruction postponed while ruling is appealed
A federal judge in South Florida has suspended an order requiring Sunrise-based U.S. Stem Cell Clinic, LLC to destroy all stem cells taken from patients while those patients pursue an appeal. (Daily Press)
Destruction of banked stem cells extracted from patients of Sunrise-based U.S. Stem Cell Clinic, LLC and its affiliates is on hold pending appeals.
The June 25 destruction order by U.S. District Judge Ursula Ungaro was part of an injunction permanently stopping the clinic and its affiliates from marketing stem cell treatments that have not been approved by the U.S. Food and Drug Administration.
The FDA sought the injunction in May 2018. It accused the clinic of using unapproved treatments on thousands of patients with serious diseases, including Parkinson’s disease, amyotrophic lateral sclerosis (known as Lou Gehrig’s disease), chronic obstructive pulmonary disease, heart disease and pulmonary fibrosis.
The treatment involves processing body fat into a stem cell product and injecting it intravenously and directly into patients’ spinal cords.
After they were notified by U.S. Stem Cell that their banked stem cells would be destroyed within 30 days of the June 25 ruling, 95 patients filed motions to intervene.
Many wrote letters saying their stem cell treatments were effective in easing symptoms of their medical conditions. “I have gone from being unable to walk at all to struggling to walk with an assistive device, and after several stem cell treatments I have beat[en] all odds and am now walking short distances without use of an assistive devices,” said one from a hunter who was shot in the head during a November 2016 hunting accident.
Critics in the medical community have cast doubt on such claims, stating the only stem cell treatments proven effective involve their use to repopulate bone marrow and make new blood cells, typically for chemotherapy recipients.
The patients’ motions to intervene were denied on July 31, but Ungaro agreed on July 19 to allow the clinic to retain the stem cells until the case is resolved in the Eleventh Circuit Court of Appeals.
Seventeen patients on Aug. 29 filed an appeal of the court’s decision to deny them status as interveners, while on Aug. 23 U.S. Stem Cell appealed the court’s entire injunction, which included barring unapproved stem cell treatments.
SOUTH FLORIDA SUN SENTINEL
SEP 11, 2019
https://www.sun-sentinel.com/business/fl-bz-us-stem-cell-destruction-postponed-pending-appeal-20190911-eq4in32unfae5e2hvjv2lqdn24-story.html
U.S. Stem Cell destruction postponed while ruling is appealed
A federal judge in South Florida has suspended an order requiring Sunrise-based U.S. Stem Cell Clinic, LLC to destroy all stem cells taken from patients while those patients pursue an appeal. (Daily Press)
Destruction of banked stem cells extracted from patients of Sunrise-based U.S. Stem Cell Clinic, LLC and its affiliates is on hold pending appeals.
The June 25 destruction order by U.S. District Judge Ursula Ungaro was part of an injunction permanently stopping the clinic and its affiliates from marketing stem cell treatments that have not been approved by the U.S. Food and Drug Administration.
The FDA sought the injunction in May 2018. It accused the clinic of using unapproved treatments on thousands of patients with serious diseases, including Parkinson’s disease, amyotrophic lateral sclerosis (known as Lou Gehrig’s disease), chronic obstructive pulmonary disease, heart disease and pulmonary fibrosis.
The treatment involves processing body fat into a stem cell product and injecting it intravenously and directly into patients’ spinal cords.
After they were notified by U.S. Stem Cell that their banked stem cells would be destroyed within 30 days of the June 25 ruling, 95 patients filed motions to intervene.
Many wrote letters saying their stem cell treatments were effective in easing symptoms of their medical conditions. “I have gone from being unable to walk at all to struggling to walk with an assistive device, and after several stem cell treatments I have beat[en] all odds and am now walking short distances without use of an assistive devices,” said one from a hunter who was shot in the head during a November 2016 hunting accident.
Critics in the medical community have cast doubt on such claims, stating the only stem cell treatments proven effective involve their use to repopulate bone marrow and make new blood cells, typically for chemotherapy recipients.
The patients’ motions to intervene were denied on July 31, but Ungaro agreed on July 19 to allow the clinic to retain the stem cells until the case is resolved in the Eleventh Circuit Court of Appeals.
Seventeen patients on Aug. 29 filed an appeal of the court’s decision to deny them status as interveners, while on Aug. 23 U.S. Stem Cell appealed the court’s entire injunction, which included barring unapproved stem cell treatments.