September 18, 2020

The Niche

Knoepfler lab stem cell blog

Search Results for: clinicaltrials.gov

3 min read

Clinicaltrials.gov is a wonderful resource for its many users, whether a patient searching for a clinical trial to actually participate in or someone doing research as I have done, but it’s not perfect and some sponsors have been breaking the rules regarding its use. It’s a major problem in fact. Based on new draft guidance it seems that the FDA and NIH are teaming up in a big new way to punish those who are non-compliant with the Clinicaltrials.gov-related regulations and laws, including potentially …Read More

4 min read

It’s hard to even imagine the world of investigative medicine without the wonderful resource of Clinicaltrials.gov, the global hub for clinical trial listings. I recently interviewed the Director of Clinicaltrials.gov, Dr. Deborah Zarin here, which is a fascinating read. As great as Clinicaltrials.gov is as a resource, unfortunately it faces a new, rapidly growing problem that is a serious threat to the site. The Clinicaltrials.gov database is including a rapidly increasing number of for-profit clinical trials that are not by any stretch of the imagination traditional clinical trials. At present, …Read More

8 min read

This post is the first in a series about the Clinicaltrials.gov website. This piece is an interview the Director, Dr. Deborah Zarin. I want to thank her for taking the time to answer my questions. Later, I will post Part 2 in which I discuss my concerns about the trend of for-profit stem cell clinic trials being listed on Clinicaltrials.gov that in my view are not conventional trials. First a little background on Clinicaltrials.gov before I get into the interview. It is the global clinical trials website …Read More

4 min read

Another week and more great papers and interesting news in the regenerative medicine sphere including COVID-19 updates, stem cells for vision, and more. Rebuilding Corneas With Stem Cells Stem cell-based regenerative medicine arguably has shown the most promise for vision loss. A PR from Massachusetts Eye and Ear says: Doctors rebuild damaged corneas using patients’ own own stem cells for first time in US. This is interesting work. The autologous transplant method is called “‘cultivated autologous limbal epithelial cell transplantation’ (CALEC).” It involves taking …Read More