Despite the continuing challenges related to the pandemic, 2021 was a year filled with exciting progress for Cook MyoSite's clinical technologies.
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Topics: cell therapy, biotechnology, clinical development
This article was originally published via RegMedNet on March 2nd, 2020.
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Topics: cell therapy, biotechnology, clinical development
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.
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Topics: regenerative medicine, clinical development, clinical trials, regulatory
This article was originally published to RegMedNet on June 16th, 2020.
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Topics: regenerative medicine, clinical development, clinical trials, regulatory
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
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.
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Topics: clinical development, clinical trials
