Cook Myosite Blog

Regenerative Medicine in Urology: Ask the Experts

Posted by Cook MyoSite on Nov 29, 2021 3:06:45 PM

This article was originally published via RegMedNet on March 2nd, 2020.

Read More

Topics: cell therapy, biotechnology, clinical development

What kind of regenerative medicine is AMDC?

Posted by Cook MyoSite on Oct 15, 2021 12:50:34 PM

In a previous post, we discussed the history of regenerative medicine from the 8th century B.C. through the present day. This exciting field has developed from its speculative roots into a broad and diverse industry with many subcategories and hundreds of therapies in development. In this post, we’ll talk about where exactly Cook MyoSite’s Autologous Muscle Derived Cells (AMDC) technology fits under the modern regenerative medicine umbrella. 

Read More

Topics: regenerative medicine, clinical development, clinical trials, regulatory

Developing endpoints for regenerative medicine: an interview with Stephen Westover

Posted by Cook MyoSite on Sep 27, 2021 2:23:21 PM

This article was originally published to RegMedNet on June 16th, 2020. 

Read More

Topics: regenerative medicine, clinical development, clinical trials, regulatory

Webinar: Lessons Learned from RMAT Submission, Denial, and Successful Resubmission

Posted by Cook MyoSite on Sep 14, 2021 11:48:51 AM

In this webinar, originally presented via RegMedNet on April 15th, 2021, the Regulatory experts at Cook MyoSite walk attendees through the company's experience applying for the FDA's Regenerative Medicine Advanced Therapy (RMAT) designation, receiving an initial rejection, and reapplying to successfully obtain the designation.

Read More

Topics: regenerative medicine, clinical development, clinical trials, regulatory

Why Participate in a Clinical Trial?

Posted by Cook MyoSite on Aug 30, 2021 11:47:50 AM
Red and Black Quotes Instagram Post

Why participate in a clinical trial?

Clinical trials are studies in which new treatments (drugs, devices, or biologics) are tested using human volunteers. These potential new treatments might be tested against the efficacy of another treatment intended for the same condition, be tested against a placebo, or against an untreated group (more on that in our previous post). Clinical trials provide the necessary rigorous testing of a treatment before it is approved for use in the general population.  

Read More

Topics: clinical development, clinical trials