Etiqueta: FDA
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The Wild West of Stem Cells in the U.S. With Roberta Shapiro, DO, FAAPMR
Roberta Shapiro, DO, FAAPMR, specializes in musculoskeletal pain disorders and regenerative medicine. She is also an assistant clinical professor of medicine at the prestigious Columbia University Irving Medical Center. Dr. Shapiro joined our founder, Neil Riordan, PA, Ph.D., in 2019 to discuss the state of stem cell therapy in the United States. Dr. Shapiro…
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Multiple Sclerosis News Today Covers Stem Cell Institute Clinical Trial for MS
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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.…
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FDA DRAFT STEM CELL GUIDANCE DOCUMENTS EXPOSED AS IMPROPER RULEMAKING, BAD SCIENCE AND HEARTLESS PUBLIC POLICY
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…
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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…
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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…
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Duchenne’s Patient Ryan Benton Discusses His Experience with Stem Cell Therapy
Ryan Benton is the first patient in the United States to receive human umbilical cord-derived mesenchymal stem cell therapy for Duchenne’s muscular dystrophy. The US FDA granted Ryan this trial under compassionate use. Ryan first began treatments at the Stem Cell Institute in Panama before being able to receive treatments in his hometown of Wichita,…
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After FDA Approval, Duchenne’s Muscular Dystrophy Patient Receives First Umbilical Cord Stem Cell Treatment in the United States
Ryan Benton, a 28 year-old Duchenne’s muscular dystrophy patient from Wichita, Kansas, received his first umbilical cord tissue-derived mesenchymal stem cell treatment yesterday at Asthma and Allergy Specialists of Wichita, KS following US FDA approval of his doctor’s application for a single patient, investigational new drug (IND) for compassionate use. Wichita, KS (PRWEB) September 10,…
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Neil Riordan PhD – on opening a stem cell clinic in the United States
Stem Cell Pioneers featured Dr. Riordan in its February installment of «Ask the Doctor», a monthly segment that features stem cell scientists and doctors answering questions from readers about stem cell therapy. Over the next several days, we will share these questions and Dr. Riordan’s answers with our readers. Question for Dr. Riordan: If the…