I had the honor of interviewing Kyle Cetrulo, CEO of AuxoCell Laboratories. In this interview, we explore the upcoming Future of Regenerative Medicine Congress, as well as future directions for regenerative medicine at large. Enjoy. [Read more…]
Founded in 2011, Okyanos (pronounced “Oh – key – AH – nos”) is an innovative stem cell therapy provider that specializes in treating patients with congestive heart failure (CHF) and other chronic conditions. The literary name Okyanos, the Greek God of the river Okyanos, symbolizes the restoration of blood flow. Okyanos Cell Therapy delivers a mixed population of fat (adipose) derived stem and regenerative cells (ADRCs) using internationally-approved technology to patients with chronic, degenerative conditions. Okyanos is fully licensed under the Bahamas Stem Cell Therapy and Research Act and adheres to U.S. surgical center standards. [Read more…]
To understand the growing market potential for stem cell therapies, it is critical to consider the current landscape for stem cell clinical trials.
There are 5561 clinical trials found when the term “stem cells” is searched on ClinicalTrials.gov, indicating that there are now thousands of stem cell trials underway worldwide. (Search executed November 7, 2016.)
ClinicalTrials.gov is the global registry of publicly and privately supported clinical studies involving human patients. While not a comprehensive resource, it contains approximately three-quarters of registered cell therapy trials worldwide.
Below is a map showing the location of current stem cell clinical trials.
Map of Stem Cell Clinical Trials, by Geographical Region
“Hotspots” for Stem Cell Clinical Trial Activity
Clearly, North America (3057 trials) and Europe (1288 trials) are “hotspots” for stem cell clinical trial activity.
Among the North American trials, nearly all of them of them are occurring in the United States (2935). [Read more…]
Boston BioLife (www.bostonbiolife.com) is a cutting-edge organization that provides workshops for physicians and scientists interested in learning regenerative medicine. Its mission is to facilitate the introduction of emerging life sciences technologies to scientists and healthcare providers. [Read more…]
Nearly everyone in the stem cell community knows that there was supposed to be a FDA public hearing on April 13, 2016, related to four draft guidances controlling the regulation of stem cells.
Officially called a public hearing on “Draft Guidances Relating to the Regulation of Human Cells, Tissues or Cellular or Tissue-Based Products Part 15,” the event was to be held at the FDA White Oak Campus located at 10903 New Hampshire Ave., Bldg. 31, Rm 1503 (Great Room), Silver Spring, MD, 20993.
To enroll for the event, you had to email “CBERPublicEvents@fda.hhs.gov” with your request to attend, contact information, and whether or not you wished to be a presenter. Whether it was intentional or not, very little time was given for the registration, which ended on on Jan. 8th, 2016, more than three months before the event was scheduled. [Read more…]