Clinical Applications

Cook MyoSite® is on a mission to personalize regenerative medicine.

 

  • Overview
  • Technology
  • Clinical Trials
  • FAQ

Cook MyoSite is investigating and researching personalized regenerative medicine with AMDC, Autologous Muscle Derived Cells. The Cook MyoSite AMDC technology is under investigation in a number of clinical trials and is not commercially available at this time. For more information on the Cook MyoSite clinical trials, please visit www.clinicaltrials.gov.

AMDC Technology

First, the patient undergoes a biopsy procedure where the physician removes a small piece of muscle from the thigh.

 

Next, the biopsy is sent to Cook MyoSite, where a group of highly trained operators isolate a specific population of cells from the muscle. Those cells are grown in the manufacturing facility at Cook MyoSite to specific qualifications. The patient’s own cells are then frozen and shipped back to the physician’s office or hospital.

 

Finally, the physician thaws and injects the patient’s own cells back into their damaged or under-functioning tissue.

 

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.

clinical-process

The Cook MyoSite AMDC technology is being evaluated in clinical trials throughout Canada, Europe, and the United States and is not commercially available at this time. For full details on the Cook MyoSite clinical trials, please visit www.clinicaltrials.gov.

 


Stress Urinary Incontinence (SUI)

Phase III – Female Urinary Sphincter Repair for Stress Urinary Incontinence (SUI)

Find more information about this clinical trial at http://researchsui.com/

 

Phase I/II – Male Urinary Sphincter Repair for Stress Urinary Incontinence (SUI) following Prostate Surgery

Find more information about this clinical trial at https://www.malesui.com

 

The patient’s own cells are injected into the urinary sphincter during an outpatient procedure. The procedure is minimally invasive, requires only local anesthesia, and normally takes less than 15 minutes. The Cook MyoSite technology is being evaluated for the treatment of patients who have the symptoms of SUI and have not responded to prior treatments.


Fecal Incontinence (FI)

Phase I/II – Anal Sphincter Repair for Fecal Incontinence (FI)

Find more information about this clinical trial at http://www.gifistudy.com

 

The aim of this clinical study is to investigate the safety and feasibility of Autologous Muscle Derived Cells (AMDC; a preparation of a patient’s own cells) injection into the anal sphincter for treatment of patients with fecal incontinence.

 

 


Underactive Bladder (UAB)

Phase I/II – Urinary Tissue Repair for Underactive Bladder (UAB)

 

This is a prospective, open-label, Phase 1, single center study evaluating the safety and efficacy of autologous muscle derived cells as a treatment for chronic underactive bladder.

 


Tongue Dysphagia

Phase I/II – Gastrointestinal Repair for Tongue Dysphagia (TD)

 

The patient’s own cells are injected into the tongue. The Cook MyoSite technology is being evaluated for the treatment of patients who have the symptoms of TD and have not responded to prior treatments.

 

  • Are you a physician interested in working with Cook MyoSite on a clinical trial?
    • If you are a physician and are interested in learning more about the Cook MyoSite clinical trials, contact our clinical team using the contact form on this website. Select the “Inquire about clinical research” option.
  • Are you a patient interested in learning more about volunteering to take part in either the Female Stress Urinary Incontinence (SUI) clinical trial, the Male Urinary Sphincter Repair for Stress Urinary Incontinence (SUI) following Prostate Surgery clinical trial, or the Anal Sphincter Repair for Fecal Incontinence (FI) (Canada only) clinical trial?
    • Potential study participants can find out if they may be eligible to participate in the Female Stress Urinary Incontinence (SUI) clinical trial at http://researchsui.com/.

       

    • Potential study participants can find out if they may be eligible to participate in the Male Urinary Sphincter Repair for Stress Urinary Incontinence (SUI) following Prostate Surgery clinical trial at https://www.malesui.com.

       

    • Potential study participants can find out if they may be eligible to participate in the Anal Sphincter Repair for Fecal Incontinence (FI) (Canada only) clinical trial at http://www.gifistudy.com.

       

    • For information on all the Cook MyoSite clinical trials, visit www.clinicaltrials.gov.

 

Have other questions about the Cook MyoSite clinical applications? Send us a message.