The purpose of this study is to asses the efficacy and Safety of Allogeneic Umbilical Cord-derived Mesenchymal Stem Cells in the Treatment of Complex Perianal Fistula in Perianal Crohn's Disease.
Crohn´s disease (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 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 Allogeneic Umbilical Cord-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 TH-SC01
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Allogeneic Umbilical Cord-derived Mesenchymal Stem cells perilesional injection. Human TH-SC01 cell injection (human umbilical cord mesenchymal stem cells for injection, 5 million cells / ml, 6.0-10.0ml / bottle)
Jinling hospital
Nanjing, Jiangsu, China
Percentage of Participants who Achieve Combined Remission
Combined remission is defined as the closure of all treated external openings that were draining at baseline despite gentle finger compression, and absence of abscess(es) \>2 cm (in at least 2 dimensions) of the treated perianal fistula(s) confirmed by central magnetic resonance imaging (MRI) assessment or transrectal ultrasonography(TRUS)
Time frame: 24 weeks
Percentage of Participants who Achieve Clinical Remission
Clinical remission is defined as the closure of all treated external openings that were draining at baseline despite gentle finger compression.
Time frame: Up to Week 24
Percentage of Participants who Achieve Clinical Response
Clinical response is defined as closure of at least 50% of all treated external openings that were draining at baseline despite gentle finger compression.
Time frame: Up to Week 24
Percentage of Participants who decrease in PDAI
PDAI is a scoring system for assessing the severity of perianal lesions associated with Crohn's disease.It consists of the following five items :(a) perianal secretions;(b) Pain and movement;(c) Sexual life;(d) Perianal manifestations;(e) Sclerosing.Each item is rated on a five-point scale from asymptomatic (0) to severe (4), with an overall score of 0 to 20.The higher the score, the more severe the disease.
Time frame: 0、4、8、16、24 weeks
Percentage of Participants who decrease in IBDQ
IBDQ questionnaire score is used to investigate the quality of life of patients. There are 32 questions in total, and each question has 1 to 7 answers of different degrees, with 1 representing the most severe degree and 7 representing the least severe degree
Time frame: 0、4、8、16、24 weeks
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Percentage of Participants who decrease in VAS scale
VAS scale was used to evaluate the pain. 0 points indicated no pain, less than 3 points indicated mild pain, 4-6 points indicated pain affecting sleep but tolerable, 7-10 points indicated pain and discomfort, affecting appetite and sleep. The higher number, the pain was more obvious.
Time frame: 0、4、8、16、24 weeks
Percentage of Participants who decrease in Wexner incontinence score
Wexner incontinence score
Time frame: 0、4weeks