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Pioneering the next generation of technologies for muscle-related disorders

Cook MyoSite is on a mission to make it easier for healthcare professionals to use muscle-derived cell therapies in the pursuit of better outcomes for their patients.

This technology is currently for investigational use only; safety and effectiveness have not been established. It has not yet been evaluated by the FDA or other regulatory bodies.
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Iltamiocel: a personalized, regenerative cell therapy

Cook MyoSite’s pioneering autologous muscle-derived cell (AMDC) technology is backed by more than 20 years of rigorous clinical research and is being investigated for a variety of uses in robust clinical trials. Known as iltamiocel, this personalized, regenerative cell therapy product may have the potential to restore function to damaged or dysfunctional muscle using a patient’s own cells.

Iltamiocel is being clinically investigated for female stress urinary incontinence, fecal incontinence, and oropharyngeal dysphagia. To date, iltamiocel clinical programs have enrolled more than 700 participants.
“The inventory of cells at Cook MyoSite is unrivaled, and it’s also more readily available than other suppliers. With MyoSite, there’s a PDF that gives all the details and makes life a lot easier when selecting cells. And as I said, the quantity of samples available is really helpful for designing experiments when we want multiple donors to compare.” 
Richard Day
Professor of Regenerative Medicine Technology, University College London

Investigating iltamiocel

Iltamiocel is currently being evaluated in the following clinical studies: 
Phase III • Urinary Sphincter Repair in Post-Surgical Female Stress Incontinence
Recipient of FDA's Regenerative Medicine Advanced Therapy (RMAT) designation
This study evaluates the efficacy and safety of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR; generic name: iltamiocel) compared to a placebo in the reduction of stress incontinence episode frequency in adult female patients with post-surgical persistent or recurrent stress urinary incontinence (SUI).
Find more information about this clinical trial at clinicaltrials.gov
Phase III • Chronic Fecal Incontinence in Females with Obstetric Injury
Recipient of FDA's Regenerative Medicine Advanced Therapy (RMAT) designation
This study evaluates the efficacy and safety of a single injection of iltamiocel compared to a placebo in the reduction of fecal incontinence episode frequency in adult female participants with chronic fecal incontinence and a history of obstetric anal sphincter injury.
Find more information about this clinical trial at clinicaltrials.gov
Phase II/III • Gastro-Intestinal Repair for Oropharyngeal Dysphagia
Recipient of FDA's Regenerative Medicine Advanced Therapy (RMAT) designation
The primary objective of this study is to evaluate the safety of Autologous Muscle Derived Cells for Gastro-Intestinal Repair (AMDC-GIR) during the 12 months following treatment of Oropharyngeal Dysphagia in male and female patients who have undergone surgery and/or chemo- and/or radiotherapy for squamous cell cancer of the oropharynx.
Find more information about this clinical trial at clinicaltrials.gov
Preclinical
Phase I
Phase II
Phase III
Urinary Sphincter Repair in Post-Surgical Female Stress Incontinence
Preclinical
Phase I
Phase II
Phase III
Chronic Fecal Incontinence in Females with Obstetric Injury
Preclinical
Phase I
Phase II
Phase III
Gastro-Intestinal Repair for Oropharyngeal Dysphagia*
Preclinical
Phase I
Phase II
Phase III
*This is a physician-sponsored study.

Are you a physician or researcher interested in participating?
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Beyond the clinic: learn about our laboratory research services

Cook MyoSite’s years of experience in muscle cell technology has positioned us as a leading provider of contract research services created to support other projects which would benefit from our partnership.