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…]
Your ULTIMATE Guide to the FDA Public Hearing on “Draft Guidances” Regulating Cells and Tissues (Part 15)
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 “[email protected]” 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…]
Key Market Leaders for Adipose-Derived Mesenchymal Stem Cell (MSC) Storage
In addition to cord tissue storage, many cord blood banks are now investigating the addition of adipose-derived stem cell storage.
It is a logical product extension for cord blood banks, given that a range of collection, processing, and storage equipment is already present within the facility.
Additionally, conversion costs to allow for adipose-derived stem cell storage can be as low as USD $100,000 to $150,000.
The conversion of a cord blood facility to be able to offer adipose-derived stem cell storage can be efficiently accomplished through collaboration with a specialist in the area of adipose tissue extraction and storage.
Companies such as American Cryostem in the United States have been willing to partner with cord blood banks to assist them with adding adipose-derived MSC storage as a service.
Leading Companies Offering Mesenchymal Stem Cell (MSC) Storage
Below is an analysis of both diversified cord blood banks and specialty companies that currently offer adipose-derived stem cell storage. [Read more…]
Setting the Standard in Adipose-Derived Stem Cell Applications
This article is part two of my interview with Matthew Feshbach, CEO and Co-Founder of Okyanos (pronounced “Oh – key – AH – nos”). Founded in 2011, Okyanos specializes in treating patients with chronic, degenerative conditions. Located in Freeport, Grand Bahama, just 55 miles from the United States, Okyanos Cell Therapy combines a blend of stem and regenerative cells derived from a patient’s own adipose (fat) tissue.
Treatment is performed in their state-of-the-art surgical center by a team of U.S. licensed medical doctors. Okyanos is also fully licensed under the Bahamas Stem Cell Therapy and Research Act and adheres to U.S. surgical center standards.
Using technology from Cytori Therapeutics, the company offers a highly characterized cellular product that is administered via a robust protocol by a renowned medical team within a world-class facility. It is my opinion, that Okyanos is a company that is setting the standard for others practicing cellular therapy with adipose-derived stem and regenerative cells.
Enjoy this second half of the interview. If you haven’t read it yet, click here to view Part 1. [Read more…]
Are You Planning to Attend FDA’s September 8th Public Workshop on Development of Cellular and Tissue-Based Products?
The Food and Drug Administration has announced a public workshop entitled, “Scientific Evidence in the Development of Human Cells, Tissues, and Cellular and Tissue-Based Products Subject to Premarket Approval.” [Read more…]
