Crohn's Disease Clinical Trial
Official title:
Multicenter Phase I/IIa Study to Assess the Safety and Efficacy of Expanded Allogenic Adipose-derived Stem Cells (eASCs) (Cx601), for Treatment of Complex Perianal Fistulas in Perianal Crohn's Disease.
The purpose of this study is to asses the safety and efficacy of adipose-derived adult stem cells from healthy donnors for treatment of complex perianal fistulas in Crohn's disease.
Crohn´s disease (CD) is a severe disorder with significant morbidity and major impact on
life. CD can affect any part of the digestive system and symptoms of this chronic illness
include abdominal pain, bloating, nausea, vomiting and diarrhea. CD also causes bowel wall
ulcers, strictures (narrowing of a hollow structure due to scar tissue and swelling), and
fistulas (abnormal passages from the intestines to another organ or the skin).
There is an unmet need for effective medical therapy in CD patients with perianal fistulas,
not responding to the conventional strategies, including biological therapies. The current
study is designed to assess the safety and efficacy of adipose tissue derived mesenchymal
stem cells from healthy donors for the treatment of perianal fistulas in patients presenting
CD.
Primary objective: To assess the safety (incidence of treatment emergent adverse-events) of
eASCs.
Study design: Multicenter, pilot study, assessing safety and with evaluation of the efficacy
by two Gastroenterologists/Surgeons and an independent external radiologist. Subjects will
receive a cell suspension of allogenic adipose-derived stem cells, eASCs (20 million cells)
in the fistula.
In case of incomplete fistula closure of the treated fistula at week 12, subjects will
receive a second dose of eASCs (40 million cells). Subjects will be followed until week 24,
following the initial administration of cells.
Subjects may be treated with standard care during the entire study period, according to the
investigators discretion, excluding infliximab or any other anti-TNF, tacrolimus or
cyclosporine.
. Study population: In total 24 patients, men and women of at least 18 years of age, with
perianal CD will be recruited. Patients with a minimum of one and a maximum of three fistula
tracts.
Description of treatments: .
Subjects will receive:
Investigational product: CX-601 Suspension of adult expanded allogenic adipose-derived stem
cells (eASCs) at a doses of 20 million cells and 40 million cells.
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