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Pittsburgh, Pa., February 12, 2025 — Cook MyoSite today announced the completion of enrollment of the CELLEBRATE Study, a Phase III clinical trial evaluating the efficacy and safety of iltamiocel compared to a placebo in the reduction of stress incontinence episode frequency in adult female participants with persistent or recurrent stress urinary incontinence (SUI) despite previous surgical treatment. This milestone builds upon the significance of iltamiocel receiving the Regenerative Medicine Advanced Therapy (RMAT) designation by the U.S. Food and Drug Administration (FDA) which recognized the seriousness of this unmet need.
“We wish to express our sincere gratitude to the patients, investigators, and study teams across the multitude of sites that have participated in this momentous study,” said Ron Jankowski, Vice President, Regulatory and Scientific Affairs at Cook MyoSite. “This represents yet another important step forward in the development of an innovative and minimally invasive alternative to repeated surgical intervention in this complex patient population.”
SUI is caused by a weakening of the muscles in the pelvic region and/or urethral sphincter. Women with SUI can experience urine leakage due to sudden increases in pressure on the bladder from things like laughing, coughing, sneezing, or exercising. SUI is a very common condition in women of all ages, affecting up to 37% of women[1], and can not only affect a woman’s lifestyle and quality of life, but can also result in anxiety, depression, and social isolation. Importantly, few treatment options exist for women who continue to suffer from SUI even after undergoing repeated surgical treatment.
Conducted at 35 sites across the United States and the United Kingdom, 114 participants were enrolled in the double-blind, randomized, placebo-controlled study. Principal Investigator of the CELLEBRATE Study, Melissa Kaufman, M.D., Ph.D., shared, “We are grateful for the engagement of all involved to have reached this monumental milestone. We are eagerly anticipating future opportunities for this technology across a broad range of applications.”
Study participants will be followed for one year after treatment, and full study results are expected to be available in mid-2026.
For more information about the CELLEBRATE Study, visit www.CookMyoSite.com or www.ClinicalTrials.gov.
COOK MYOSITE, INC.
In 2002, Cook MyoSite, Incorporated was formed to guide the Cook Group organization into the expanding world of cellular technologies. Today, Cook MyoSite is dedicated to the development and subsequent commercialization of technology related to the collection, selection, and expansion of human skeletal muscle cells for the treatment of various disorders. Learn more at www.CookMyoSite.com and www.CookGroup.com.
ILTAMIOCEL
Iltamiocel is a personalized, regenerative cell therapy product being investigated by Cook MyoSite, Inc. Iltamiocel is created from a patient’s own muscle cells and are theorized to engraft into existing dysfunctional or weakened target tissue to improve muscle function. To date, more than 700 participants have contributed to the iltamiocel clinical program. Currently, iltamiocel is being clinically investigated for female stress urinary incontinence, fecal incontinence, and oropharyngeal dysphagia (tongue dysphagia). For more information on these ongoing studies, visit www.ClinicalTrials.gov.
THE CELLEBRATE STUDY
The CELLEBRATE Study is an FDA-regulated clinical trial evaluating the safety and efficacy of the iltamiocel investigational cell therapy product treating female participants with persistent or recurrent stress urinary incontinence following surgical treatment. Learn more at www.ClinicalTrials.gov.
1. Patel U., Godecker A., Giles D.L., Brown H.W. Updated Prevalence of Urinary Incontinence in Women: 2015-2018 National Population-Based Survey Female Pelvic Med Reconstr Surg 28(4):181-187, 2022. doi: 10.1097/SPV.0000000000001127
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