Cook Myosite Blog

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.

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

What Is a Clinical Trial?

Posted by Cook MyoSite on Aug 20, 2021 10:15:00 AM

What is a clinical trial? In short, clinical trials are where new medical research and people meet.

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Topics: regenerative medicine, clinical trials

What Is and Is Not a Stem Cell?

Posted by Cook MyoSite on Aug 18, 2021 4:51:44 PM

Stem cells have been the center of medical intrigue for much of the last few decades. During this time, the differences between the popular and the scientific conceptions of what is and isn’t a stem cell have grown. Often, the public's understanding of stem cells is far narrower than how the term is applied by scientists. What is a stem cell? Does Cook MyoSite work with stem cells?

A magnified image of skeletal muscle myoblasts, myocytes, and myotubes stained with Desmin (a muscle cell marker),
and DAPI (Nuclear stain). These cell types are derived from muscle satellite cells.
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Topics: regenerative medicine, stem cells

A Brief History of Regenerative Medicine

Posted by Cook MyoSite on Aug 16, 2021 1:56:00 PM

Since ancient times, humans have told stories about the body’s natural ability to regenerate. In the 8th century B.C., the Greek poet Hesiod wrote about the regenerative capabilities of the Titan Prometheus’s liver: 

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Topics: regenerative medicine