The world of regenerative medicine holds a significant amount of promise as evidenced by the World Stem Cell Summit in Miami last month.  The industry has demonstrated significant progress and growth with more than 7,000 regenerative medicine clinical trials in progress with the FDA.  However, some in the industry claim to be experts without significant experience to support the claims.   

The fact is that the FDA has applied “Discretionary Enforcement” to the rapidly growing application and delivery of stem cells until no later than November 2020.  The discretionary enforcement has led some in the industry to become the self-proclaimed watchdog over what’s right and what’s wrong.  Unfortunately, there are a number of practices that are taking advantage of the short-handed FDA which has given rise to static in the news around medical professionals looking to make a quick buck.  Some watchdogs have proliferated the static amongst industry professionals and paint a broad brush for anyone that doesn’t purchase supplies from them or contribute to their research.  

IMAC Regeneration Centers deliver regenerative medicine procedures in accordance with the policies and regulations set forth by the FDA and State Medical Boards.  Patients should have comfort knowing that licensed medical doctors deliver 100% of stem cell procedures in our clinics.  As of the date of this letter, IMAC does not recommend amniotic or placental based products that some in the industry claim to have living stem cells.  An IMAC stem cell procedure will be determined and performed by one of these physicians: 

Dr. Don Douglas:  

  • Medical School:  University of Kentucky 
  • Residency: St. Elizabeth’s Hospital, Family Practice 
  • Fellowship:  University of Kentucky, Orthopedic Surgery 
  • Fellowship:  University of Louisville, Interventional Pain Management 

Dr. Rob Garneau:  

  • Medical School:  Wayne State School of Medicine 
  • Residency: University of Iowa, Radiology 
  • Fellowship:  University of Kentucky, Neuroradiology and MRI, diagnostic radiology 

Dr. Sean McDonald:  

  • Medical School:  University of Alberta 
  • Residency:  University of Alberta – Neurosurgery 

Dr. Devin Bell:  

  • Medical School: Kansas City University of Medicine and Biosciences;  
  • Residency: Deaconess Evansville, Family Medicine 

Dr. David Smithson:  

  • Medical School:  University of Oklahoma 
  • Residency:  University of Oklahoma 
  • Fellowship:  Non-Invasive Cardiology, University of Oklahoma-Tulsa 
  • Fellowship:  Sports Medicine, American Sports Medicine Institute 

As a conservative treatment clinic, IMAC Regeneration Centers focus on delivering non-invasive and minimally-invasive therapies to improve your movement restrictions.  IMAC medical professionals deliver Regenerative Rehabilitation which is a combination of physical therapy with regenerative medicine.  If you lack proper alignment when you move, regenerative therapies alone are less likely to provide desired outcomes.  Likewise, physical therapy alone is inadequate for tissue regeneration.  Therefore, IMAC will attempt to provide stability and function to a joint prior to delivering regenerative medicine to optimize the performance of the regenerative rehabilitation.  IMAC provides approximately 10,000 medical and physical therapy procedures per month and our experience delivers the most patient satisfaction when a joint is properly prepared to host a regenerative procedure.  A patient considering a stem cell procedure should consider the function of the joint prior to only using stem cells within a care protocol. 

Physical rehabilitation at IMAC will be delivered by one or a combination of the following licensed professionals: 

  • Hallie Dew Anderson, OTR  
  • Jill Clement, DPT 
  • Aaron Colson, PT 
  • Sara Anne Davidson, DPT 
  • Michelle Flanagan, PT 
  • Andrew Ford, DPT 
  • Hillary Gibson, DPT 
  • Jeremy Graddy, DPT 
  • Kara Heath, DPT 
  • Theresa Hobson, PT 
  • Dan Jennewein, DPT 
  • Brett Koehn, PT 
  • Brian Low, DPT 
  • Sandra Miller, PT 
  • Marla Munsen, DPT 
  • Charles Renner, OTR, CHT 
  • Tommy West, DPT 

IMAC continues to lead regenerative rehabilitation with innovative medical advancements and care.  In the course of patient care, IMAC identified an unmet need for neurological conditions that restrict muscle function and decrease quality of life.  As stated in the IMAC Holdings S1 registration statement, IMAC initiated a consulting engagement in November 2017, to coordinate formal research and data collection towards developing a relationship with the FDA.  This lengthy process is necessary for companies to adequately prepare for engaging the FDA.  Leading IMAC’s scientific initiatives is Ian White, Ph.D.  His education followed by post-Doctorate experience is noted below:  

  • Doctorate:  Cornell University, Ansary Stem Cell Institute under the direction of Dr. Shahin Rafii 
    • Master of Science:  University of Liverpool, Applied Parasitology and Medical Entomology 
    • Research Assistant:  Harvard University in the laboratory of Dr. Laurie Glimcher 
    • Research Assistant:  Dartmouth College under direction of Dr. Eric Lambie 
  • Post-Doctoral Fellow:  University of Georgia in the laboratory of Dr. Stephen Dalton 
  • Research Scientist:  University of Miami, Miller School of Medicine Interdisciplinary Stem Cell Institute under the direction of Dr. Joshua Hare (January 2013 – March 2018) 
  • Lead Scientist:  Bascom Palmer Eye Institute under the direction of Alfonso Sabater, MD, PhD. (March 2018 – January 2019) 
  • Dr. White has led or been a part of 11 articles and seven awards and served as Chairman of the Scientific Committee for the American Academy of Stem Cell Physicians until November 2018.   

Evidence grows each day towards regenerative medicine applications.  Physicians and patients alike should recognize the opportunities within modern medicine and the pitfalls with those that are taking advantage of its rapid advancements.  IMAC follows published guidelines from governing authorities and will attempt to develop a relationship with the FDA soon.