FDA and Adipose Stem Cells
Several years ago we became fascinated with the potential of adipose stem cells for both cosmetic and medical purposes. However, we soon discovered that nothing in the written FDA guidelines specifically addressed the use of autologous adipose stem cells. Thus began our journey for an answer. In June 2009, we sent a letter to the FDA asking for a position statement on adipose stem cells. Our request focused specifically on autologous, freshly isolated, adipose stem cells for use in soft tissue reconstruction. These stem cells are from your own fat, for your own usage, and not culture expanded .
After a very long wait, we recently received a written response from the FDA. First, a little bit of background for any stem cell newbies.
Human cells and tissues intended for human transplant are regulated by the FDA. The FDA maintains two levels of classifications for cells and tissues: 1) HCT/P 361 and 2) HCT/P 351.
uncultured stem cells from my own fat. a tissue or a drug?
Category 361 is summarized as a tissue. A subset of category 361 includes procedures that take place in the same operative session . These same session operative procedures are exempt from FDA regulation. These procedures fall under the jurisdiction of practice of medicine. Surgeons follow guidelines and laws established by state medical boards and their professional societies, but are not controlled by the FDA. The other category, 351, is the drug/biologic category, which is completely regulated by the FDA. It is infinitely easier and faster to bring medical procedures which fall under 361 guidelines to a physicians practice compared to the 351 category.
Examples of tissues and cell types in each of the two FDA categories are as follows:
Our request simply asked the FDA if SVF (not culture expanded) adipose stem cells for autologous usage in soft tissue reconstruction in the same operative session fall under the tissue or the drug classification.
Last month we finally received a response from the FDA. Close your eyes and imagine a train coming to a screeching halt.It was not the answer we were hoping for.
Your own autologous adipose stem cells from the stromal vascular fraction (SVF) used for reconstruction and repair in the same operative session are considered by the FDA to be a DRUG.
What is interesting to us is that hematopoeitic stem cells and IVF procedures are both not classified as drugs, but uncultured fat stem cells are. The FDAs main consideration for classifying adipose stem cells as a drug was because the cells are more than minimally manipulated. So what about IVF procedures? Is creating a human from a sperm and an egg only a minimal manipulation?
To make a long story short, the drug classification will add several years to the equation for surgeons manually performing therapies with adipose stem cells. In our opinion, the FDAs new position on adipose stem cells will likely have two effects:
The new FDA position means that any surgeon who wishes to use the SVF fraction (centrifuged adipose tissue plus collagenase to yield higher numbers of stem cells) must now submit an IND (Investigational New Drug Application) to the FDA and have an approved IRB (Institutional Review Board) with a hospital. This submittal process is extremely time consuming, requires many resources, and is expensive. Some surgeons will simply move their trials, therapies, and clinics offshore.
This FDA position essentially takes surgeons performing manual processing with collagenase in their ORs out of the physician practice equation for the near future. Therefore, this FDA position likely benefits adipose stem cell device makers who process adipose tissue as they are much further along in the approval process with the FDA. Device makers will likely be first to market with their autologous stem cell processes.
No. But it is not out of the question that the FDA may put fat grafting under the magnifying glass in the future.
Fat grafting uses fat obtained from liposuction. The fat is harvested with a cannula, decanted, and processed via centrifugation techniques. A portion of the processed fat is then reinjected into areas for cosmetic enhancement. The enhancements primarily involve restoring volume and fullness.
Although fat grafting does not use collagenese to isolate the stem cells, the dirty little secret is that high density fat grafting does contain small numbers of stem cells. These stem cells are found in the fat pellet separated via centrifugation after the tumescent liposuction procedure. The mechanical forces of the liposuction procedure act to separate the mesenchymal stem cells from the blood vessels. This is all within the great science of stem cell activation. Plastic surgeons have recently come to understand that the small population of stem cells in the fat pellet provide more vascularity to fat grafts. High density fat grafting results in long lasting fat grafts and healthier looking skin.
by Leeza Rodriguez CosmeticSurg Staff Writer Leeza Rodriguez on Google +
Posted in Fat Stem Cells
Read the rest here:
FDA: Stem Cells from Your Own Fat are a Drug ...
- 001 Treating Adult Artritis with Stem Cells Shows Incredible Promise [Last Updated On: June 30th, 2010] [Originally Added On: June 29th, 2010]
- 002 Fat Stem Cells May Help Bone Healing & Recovery [Last Updated On: July 6th, 2010] [Originally Added On: July 6th, 2010]
- 003 Fat Transfer Breast Augmentation | Stem Cell | Dr. Todd Malan - Video [Last Updated On: October 14th, 2011] [Originally Added On: October 14th, 2011]
- 004 WFAA Story -- Fat and Stem Cells Used for Reconstruction - Video [Last Updated On: October 14th, 2011] [Originally Added On: October 14th, 2011]
- 005 Doctor discussing fat stem cell therapy - Video [Last Updated On: October 15th, 2011] [Originally Added On: October 15th, 2011]
- 006 Stem Cells Orlando Florida - Video [Last Updated On: October 16th, 2011] [Originally Added On: October 16th, 2011]
- 007 Stem Cells from Liposuction Fat: Plastic Surgery's New Frontier - Video [Last Updated On: October 17th, 2011] [Originally Added On: October 17th, 2011]
- 008 What are PRP's and what is the difference between PRP's and the Stem Cells you use from fat? - Video [Last Updated On: October 17th, 2011] [Originally Added On: October 17th, 2011]
- 009 Local surgeon uses stem cells and fat to enhance breasts - Video [Last Updated On: October 18th, 2011] [Originally Added On: October 18th, 2011]
- 010 A holistic approach: Part 1: Anti-Aging Treatment with Patient-Derived Fat Stem Cells; Part 1 - Video [Last Updated On: October 18th, 2011] [Originally Added On: October 18th, 2011]
- 011 Stem Cells Becoming Key In Bone Growth - Video [Last Updated On: October 18th, 2011] [Originally Added On: October 18th, 2011]
- 012 Kansas' First In-Clinic Adipose Stem Cell Procedure - Video [Last Updated On: October 18th, 2011] [Originally Added On: October 18th, 2011]
- 013 Where Do The Stem Cells Come From? Hollywood | Los Angeles - Video [Last Updated On: October 18th, 2011] [Originally Added On: October 18th, 2011]
- 014 Adivive (Lipokit) Autologous Fat Transfer with Adult Stem Cells - Video [Last Updated On: October 18th, 2011] [Originally Added On: October 18th, 2011]
- 015 Why should I store my Fat and Stem Cells? - Video [Last Updated On: October 18th, 2011] [Originally Added On: October 18th, 2011]
- 016 Autistic child received Adistem fat stem cell treatment Vasilis Paspaliaris - Video [Last Updated On: October 18th, 2011] [Originally Added On: October 18th, 2011]
- 017 Stem cells from body fat promising Video Reuters - Video [Last Updated On: October 18th, 2011] [Originally Added On: October 18th, 2011]
- 018 Vet-Stem Medistem Cellmedicine Rheumatoid Arthritis Stem Cell Video.mp4 - Video [Last Updated On: October 18th, 2011] [Originally Added On: October 18th, 2011]
- 019 Fat Stem Cell Treatment for Diabetes - Patient testimonial - Video [Last Updated On: October 18th, 2011] [Originally Added On: October 18th, 2011]
- 020 Regenerative Matrix Adipose Stem Cell Injection, EmCyte Global Biologics - Video [Last Updated On: October 18th, 2011] [Originally Added On: October 18th, 2011]
- 021 Use of Fat Stem Cell In Restore Volume- Face Lift - Non Surgical Therapy.flv - Video [Last Updated On: October 18th, 2011] [Originally Added On: October 18th, 2011]
- 022 Rheumatoid Arthritis Fat Stem Cell Therapy - Video [Last Updated On: October 18th, 2011] [Originally Added On: October 18th, 2011]
- 023 Aesthetic and Regenerative Treatments with Autologous Stem Cells - Video [Last Updated On: October 19th, 2011] [Originally Added On: October 19th, 2011]
- 024 Welcome to StemCellMD.org where we specialize in Stem Cell Treatments - Video [Last Updated On: October 19th, 2011] [Originally Added On: October 19th, 2011]
- 025 Topeka Kansas MediVet Adipose Stem Cell Procedure - Video [Last Updated On: October 19th, 2011] [Originally Added On: October 19th, 2011]
- 026 Dog Arthritis treatment - Stem Cell Therapy. - Video [Last Updated On: October 19th, 2011] [Originally Added On: October 19th, 2011]
- 027 Fat Stem Cells Multiple Sclerosis Mice - Video [Last Updated On: October 19th, 2011] [Originally Added On: October 19th, 2011]
- 028 CHA STATION Live Surgery (Stem Cell + Lipotransfer) - Video [Last Updated On: October 19th, 2011] [Originally Added On: October 19th, 2011]
- 029 Stem Cell Regenerative Centre - Video [Last Updated On: October 20th, 2011] [Originally Added On: October 20th, 2011]
- 030 Adistem - Anti-aging Conference Presentation, Adipose Stem Cells - Part 1 - Video [Last Updated On: October 20th, 2011] [Originally Added On: October 20th, 2011]
- 031 Fat Transfer Dr Amar Fat Transfer Using Your Own Adult Stem Cells - Video [Last Updated On: October 20th, 2011] [Originally Added On: October 20th, 2011]
- 032 How Fat Stem Cells May Work on Autoimmune Diseases (Rheumatoid Arthritis, Multiple Sclerosis, etc) - Video [Last Updated On: October 20th, 2011] [Originally Added On: October 20th, 2011]
- 033 Stem Cells and Fat Storage - Video [Last Updated On: October 20th, 2011] [Originally Added On: October 20th, 2011]
- 034 Medical tourism in Croatia - Uses of Stem cells from fat tissue (Harvard University) - Video [Last Updated On: October 20th, 2011] [Originally Added On: October 20th, 2011]
- 035 Dr. Todd Malan, Ch. 5 Morning News: Stem Cell Banking - Video [Last Updated On: October 21st, 2011] [Originally Added On: October 21st, 2011]
- 036 Dr Jeffry Schafer of New Image San Diego Talks About Fat Cell Transfer. CW6 Morning News. - Video [Last Updated On: October 21st, 2011] [Originally Added On: October 21st, 2011]
- 037 New Hepatitis C and Cirrhosis Treatment Cure for Liver Disease using Stem Cells - Video [Last Updated On: October 21st, 2011] [Originally Added On: October 21st, 2011]
- 038 New Stem Cell Therapy Helps Heal Pets - Video [Last Updated On: October 21st, 2011] [Originally Added On: October 21st, 2011]
- 039 Alzheimer's Disease: Spotlight on Stem Cell Research - Rod Shankle - Video [Last Updated On: October 21st, 2011] [Originally Added On: October 21st, 2011]
- 040 Stem cells implant extracted from fat - Video [Last Updated On: October 21st, 2011] [Originally Added On: October 21st, 2011]
- 041 Dr. Joseph Purita on NBC 6 News Talking About Bartolo Colon - Video [Last Updated On: October 21st, 2011] [Originally Added On: October 21st, 2011]
- 042 How Does Stem Cell Therapy Work? - Video [Last Updated On: October 21st, 2011] [Originally Added On: October 21st, 2011]
- 043 1 CHA STATION ADSC Separation Video Dr Shin, Mook-Seok (PNC INT) - Video [Last Updated On: October 21st, 2011] [Originally Added On: October 21st, 2011]
- 044 Fat Stem Cell Therapy for Multiple Sclerosis - Video [Last Updated On: October 22nd, 2011] [Originally Added On: October 22nd, 2011]
- 045 Stem Cells Face Lift Orlando EternaMD - Video [Last Updated On: October 22nd, 2011] [Originally Added On: October 22nd, 2011]
- 046 Fat Stem Cell Therapy Publication - Video [Last Updated On: October 22nd, 2011] [Originally Added On: October 22nd, 2011]
- 047 Fox news featuring Fat grafting_Adipose stemcells with Dr Roger AMAR FAMI founder - Video [Last Updated On: October 22nd, 2011] [Originally Added On: October 22nd, 2011]
- 048 American Cryostem Overview -Adult Stem Cell Storage from Fat - Video [Last Updated On: October 23rd, 2011] [Originally Added On: October 23rd, 2011]
- 049 Fat grafting, Dr Roger Amar New Frontier in WB2 - Fat Stem Cells injection. - Video [Last Updated On: October 24th, 2011] [Originally Added On: October 24th, 2011]
- 050 Stroke Patient Uses Fat Stem Cells - Interview at 5 Month's after stem cell therapy - Video [Last Updated On: October 25th, 2011] [Originally Added On: October 25th, 2011]
- 051 Patient Interview Prior to Fat Stem Cell Therapy for Stroke-Demonstration of Arm Movement - Video [Last Updated On: October 25th, 2011] [Originally Added On: October 25th, 2011]
- 052 NaturalFillĀ® Natural Stem Cell Enriched Fat Transfer Smooths Wrinkles and Enhances Breasts - Video [Last Updated On: October 28th, 2011] [Originally Added On: October 28th, 2011]
- 053 Dr. David Steenblock [Last Updated On: October 28th, 2011] [Originally Added On: October 28th, 2011]
- 054 What is Fat and/or Stem Cell Banking? - Video [Last Updated On: October 28th, 2011] [Originally Added On: October 28th, 2011]
- 055 Rheumatoid Arthritis Stem Cell Treatment - Video [Last Updated On: October 31st, 2011] [Originally Added On: October 31st, 2011]
- 056 CHA-STATION-DR.ALICE MICHAEL STEM CELL TREATMENT USING LIPO FAT TRANSFER - Video [Last Updated On: November 6th, 2011] [Originally Added On: November 6th, 2011]
- 057 Stem Cell Therapy: Psoriatic Arthritis Treatment - Video [Last Updated On: November 8th, 2011] [Originally Added On: November 8th, 2011]
- 058 Stem Cell Treatments for Psoriatic Arthritis: A Case Study - Video [Last Updated On: November 9th, 2011] [Originally Added On: November 9th, 2011]
- 059 StemCellTV Daily Report-November 9, 2011 - Video [Last Updated On: November 15th, 2011] [Originally Added On: November 15th, 2011]
- 060 Stem Cells: Treatment for Cerebral Palsy - Video [Last Updated On: November 18th, 2011] [Originally Added On: November 18th, 2011]
- 061 Fat-Derived Stem Cells for Tissue Repair: Michael Longaker - CIRM Science Writer's Seminar - Video [Last Updated On: November 18th, 2011] [Originally Added On: November 18th, 2011]
- 062 David Sagan of Venus Concept at the CACS Annual Conference - Video [Last Updated On: November 19th, 2011] [Originally Added On: November 19th, 2011]
- 063 Dr. Brian Herzog Discusses the Future of Stem Cells at the Evolution of Fat Workshop in Dallas, TX - Video [Last Updated On: November 24th, 2011] [Originally Added On: November 24th, 2011]
- 064 StemCellTV at the "Evolution of Fat" Workshop - Video [Last Updated On: November 24th, 2011] [Originally Added On: November 24th, 2011]
- 065 Craig Saunders Discusses Stem Cell Education at the Evolution of Fat Workshop in Dallas, TX - Video [Last Updated On: November 24th, 2011] [Originally Added On: November 24th, 2011]
- 066 Dr Larry Jinks at the Evolution of Fat Workshop in Dallas, TX - Video [Last Updated On: November 24th, 2011] [Originally Added On: November 24th, 2011]
- 067 Dr. Matt Travato at the Evolution of Fat Workshop Discusses Liposuction Comparison Study - Video [Last Updated On: November 26th, 2011] [Originally Added On: November 26th, 2011]
- 068 Clinical Scientist David Angeloni Discuss Fat Viability Using Tickle Lipo - Video [Last Updated On: November 27th, 2011] [Originally Added On: November 27th, 2011]
- 069 Bigger Breasts using Stem Cells and Fat Transfer? - Video [Last Updated On: December 3rd, 2011] [Originally Added On: December 3rd, 2011]
- 070 Stem cells for dogs? New pain management therapy works for pets - Video [Last Updated On: December 7th, 2011] [Originally Added On: December 7th, 2011]
- 071 StemCellTV talks to Alice Davis-Lipo Sales - Video [Last Updated On: December 7th, 2011] [Originally Added On: December 7th, 2011]
- 072 Adult Stem Cell Therapy for Rheumatoid Arthritis and Osteoarthritis - Neil Riordan, PhD - Video [Last Updated On: December 7th, 2011] [Originally Added On: December 7th, 2011]
- 073 StemCellTV Daily Report-November 23, 2011 - Video [Last Updated On: December 7th, 2011] [Originally Added On: December 7th, 2011]
- 074 Using Your Own Fat Stem Cells For Arthritis, Sports Injuries and Autoimmune Disorders - Video [Last Updated On: December 9th, 2011] [Originally Added On: December 9th, 2011]
- 075 StemCellTV Daily Report-November 24, 2011 - Video [Last Updated On: December 9th, 2011] [Originally Added On: December 9th, 2011]
- 076 BioLife Administrative Manager Talks About BioLife Cell Banking - Video [Last Updated On: December 12th, 2011] [Originally Added On: December 12th, 2011]
- 077 Stem Cell Therapy - Cerebral Palsy Treatment || Holly Catalano Update - Video [Last Updated On: December 20th, 2011] [Originally Added On: December 20th, 2011]
- 078 Could Fat Save Your Life - Video [Last Updated On: December 29th, 2011] [Originally Added On: December 29th, 2011]
- 079 StemCellTV Daily Report-November 25, 2011 - Video [Last Updated On: January 5th, 2012] [Originally Added On: January 5th, 2012]
- 080 StemCellTV Daily Report-November 26, 2011 - Video [Last Updated On: January 5th, 2012] [Originally Added On: January 5th, 2012]