Introduction
chronic disorder, fistula, Crohn’s disease, UC
CHRONIC DISORDER, INFLAMMATION, PROLIFERATION, COMPLICATION
Crohn’s disease (CD) is a complex, chronic disorder that primarily affects the digestive system. CD involves an abnormal immune response that causes excess inflammation. Anal fistula is the most common complication of CD [Mesenchymal stromal cells (MSCs) are defined as a plastic-adherent cell population that can be induced to differentiate in vitro into cells of osteogenic, chondrogenic, and adipogenic lineages. MSCs can exert immunomodulatory and anti-inflammatory function by secreting a variety of bioactive molecules and regulating local immune response [Although MSCs can be readily harvested from adipose tissue, liposuction is an invasive surgical procedure. Umbilical cord (UC) is an attractive alternative to adipose. Compared to MSCs derived from adult adipose, UC-MSCs may be cultured longer and have higher proliferation capacity [We conducted a single-arm, pilot study to evaluate the safety and effects of TH-SC01, an investigational, allogeneic, umbilical cord-derived, off-the-shelf MSC product candidate, to treat patients with pfCD that was refractory to conventional and/or biological treatments. We hypothesized that UC-MSCs locally injected around perianal fistulas were safe and effective at the end of the 24-week follow-up and could increase the health-related quality-of-life scores.