FDA poised to outlaw breast reconstruction for breast cancer survivors using their own fat tissue

The U.S. Food and Drug Administration held public hearings for two days this week to allow for public commenting on proposed guidance relating to the regulation of human cells, tissues or tissue-based products. In its current form, this guidance will classify a woman’s own fat tissue as a drug when used in breast reconstruction procedures. [...]

FDA poised to outlaw breast reconstruction for breast cancer survivors using their own fat tissue2021-02-26T14:15:17-06:00

FDA Draft Stem Cell Guidance Documents Exposed as Improper

Go to Original Post on RickJaffe.com Today was a good day for people who want continued access stem cells outside of clinic trials, and also for people who want the FDA to allow faster access to this promising technology. There was a wide spectrum of opinions. Some stem cell companies involved in clinical trials wanted [...]

FDA Draft Stem Cell Guidance Documents Exposed as Improper2021-03-01T10:00:27-06:00

US FDA Green Lights Second Duchenne’s Muscular Dystrophy Patient To Receive Human Umbilical Cord Stem Cells In US

(PRWEB) MAY 26, 2016 After several promising treatments in Panama using stem cell technology developed by Medistem Panama Inc. at the City of Knowledge in Panama, a 6 year-old Duchenne’s muscular dystrophy patient received his first umbilical cord tissue-derived mesenchymal stem cells in the US earlier this year following FDA approval of a second application [...]

US FDA Green Lights Second Duchenne’s Muscular Dystrophy Patient To Receive Human Umbilical Cord Stem Cells In US2021-03-01T10:49:22-06:00

New article concludes US FDA restrictions hampering stem cell therapy progress

An article published this month in Thieme Journal of Knee Surgery entitled, "The Use of Biologic Agents in Athletes with Knee Injuries" concluded that "Biologic agents... are becoming the mainstay of nonoperative therapy in the high-demand athletic population." but "...Unfortunately, strict regulations by the FDA continue to restrict their application in clinical practice." The good [...]

New article concludes US FDA restrictions hampering stem cell therapy progress2021-04-06T15:35:04-05:00

First Duchenne’s Muscular Dystrophy Patient To Receive Umbilical Cord Stem Cell Therapy In US Turns 30

The first patient with Duchenne Muscular Dystrophy to be granted FDA approval for allogeneic adult stem cell therapy in the United States turned 30 this year, well surpassing his original life expectancy and paving the way for future patients, according to non-profit organization Coming Together For A Cure. WICHITA, KANSAS (PRWEB) MAY 18, 2016 - [...]

First Duchenne’s Muscular Dystrophy Patient To Receive Umbilical Cord Stem Cell Therapy In US Turns 302021-03-01T12:32:49-06:00

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