[North Miami, FL – [August 21, 2024] – Segal Trials is proud to announce the completion of the first injection procedure in the DigniFI Study. The Women’s Health Team, under the leadership of Principal Investigator Steven Chavoustie, M.D., FACOG and Sub-Investigator Brittany Berre MSN, ARNP, FNP-C, worked diligently to prepare for this vital women's health study. The study's first injection procedure was performed on August 19, 2024.. Segal Trials also completed the first muscle tissue procurement procedure for the study on March 21, 2024.
Chronic fecal incontinence from an obstetrical injury (e.g., episiotomy, perineal tear) can affect up to 1 in 10 women over their lifetime1. This innovative and new potential treatment option may provide relief from this life-altering condition and improve quality of life, if successful.
“On behalf of Cook MyoSite, we are very excited to announce the first participant treated as part of the DigniFI Study,” said Ron Jankowski, Vice President, Regulatory and Scientific Affairs at Cook MyoSite. “We continue our dedicated efforts toward researching and advancing personalized cell therapy treatments for underserved and serious quality of life conditions which, unfortunately, are all-too common in the realm of women’s health. Today marks an important milestone in advancing potential treatment options for women experiencing chronic fecal incontinence symptoms, an understated and serious condition with unmet medical need.”
“This milestone is a testament to the incredible teamwork and dedication of our staff,” said Dr. Steven Chavoustie, the principal investigator for this study at Segal Trials. “We are thrilled to have been at the forefront of such a significant advancement in women’s health. The successful completion of this procedure opens new doors for the future of muscle repair therapies, and we are excited to continue our collaboration with Cook Myosite in advancing clinical research. ”For more information about participation in the DigniFI study or other clinical research initiatives at Segal Trials, please contact 305-722-8444 or marketing@segaltrials.com, or visit https://dignifistudy.com/.
About Segal Trials:
Segal Trials, founded in 1998, is a privately held network of research sites throughout South Florida conducting Phase I-IV research trials that have led to 56 FDA-approved medications and devices. The company’s trials focus on psychiatry, neurology, addiction, insomnia, infectious diseases, and women’s health in outpatient and inpatient settings.
About Cook MyoSite:
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.
About 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. For more information on the iltamiocel clinical program, visit www.ClinicalTrials.gov.
About the DigniFI Study
The DigniFI Study is an FDA-regulated clinical trial evaluating the safety and efficacy of an investigational cell therapy product created from a woman's own muscle cells in treating chronic fecal incontinence in women with a history of obstetric anal sphincter injury, such as an episiotomy or perineal tear. Learn more at https://dignifistudy.com
1. Whitehead WE, Borrud L, Goode PS, Meikle S, Mueller ER, Tuteja A, et al. Fecal incontinence in US adults: epidemiology and risk factors. Gastroenterology. 2009;137(2):512-7, 7 e1-2. doi: 10.1053/j.gastro.2009.04.054. PubMed PMID: 19410574; PubMed Central PMCID:PMCPMC2748224.
2. SOLACE Foundation. (n.d.). https://www.solaceforwomen.org/support