September 18, 2020

The Niche

Knoepfler lab stem cell blog

adipose stem cells

2 min read

Stem cell biotech company Bioheart ($BHRT) has had a rough 2015 so far. Could this year be a decisive, negative tipping point for the company? It has a number of clinical trials going, but from my view things seem increasingly uncertain. An oddity amongst stem cell biotechs, Bioheart and its leadership have at times seemed to toy with what some might view as controversial projects. Kristin Comella, CSO of Bioheart, has played a major role in other ventures including in the past with the Ageless Institute, a stem …Read More

7 min read

I invited the Chief Scientific Officer (CSO) of Bioheart, Kristin Comella, to do an interview after hearing some buzz that this could be a critical time for the company and that it might have been recently visited by the FDA. Note that Comella not just Bioheart CSO, but also the primary instructor for physician training in stem cell methods offered by the company US Stem Cell Training. Can you update us on how Bioheart is doing with its clinical trials/INDs? Comella: Our completed clinical trials of …Read More

17 min read

When I started blogging in 2010 the stem cell arena was a very different place including the fact I could count the number of US stem cell clinics on one hand. This blog, called The Niche for many years, was just “Knoepfler Stem Cell Blog” back then. Also, back then the hot topic was the battle over the legality of federal funding of embryonic stem cell research. That battle is over, or at least in hibernation, with a 2013 federal court ruling allowing such funding …Read More

6 min read

Is it the beginning of the end for dubious American clinics that sell transplants of unproven and non-FDA approved fat stem cell injections? As the year of 2014 was winding down, the FDA issued two key new draft guidances (see here and here) that could prove to be crash diets for these burgeoning fat stem cell clinics. (Update: As of 2020, the FDA has now clearly defined fat stem cells as drug products and filed suit against two firms marketing unapproved fat stem cells.) These new FDA guidances indicate …Read More