Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the efficacy of human TH-SC01 cell injection for the treatment of perianal fistulas in Crohn's Disease over 24 weeks.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Experimental | 120 million cells administered by intralesional injection. |
|
| Placebo-control group | Placebo Comparator | 24 mL saline solution by intralesional injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human TH-SC01 cell injection | Other | Human TH-SC01 cell injection is a cell suspension in aseptic buffered solution containing human expanded umbilical cord-derived stem cells of allogeneic origin in disposable vials with no preservative agents. The cells will be given at a dose of 120 million cells (5 million cells / mL) for intralesional injection. |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects achieved combined remission | Combined Remission of perianal fistulising Crohn's disease defined as the all treated external openings achieved clinical remission at week 24, and absence of collections > 2 cm of the treated perianal fistulas confirmed by centrally blinded MRI assessment by week 24. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects achieved clinical remission | Clinical Remission defined as closure of all treated external openings that were draining at baseline despite gentle finger compression, and no obvious fistulas can be felt by digital examination,as clinically assessed. | 24 weeks ,52 weeks and104 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jueyu Xia, Master | Contact | 025-52700103 | xiajueyu@topcelbio.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Topcel-KH Pharmaceutical Co., Ltd. | Recruiting | Nanjing | Jiangsu | China |
Not provided
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Saline solution | Other | Placebo (saline solution) will be given also for intralesional injection at the same quantity (volume, 24 mL) and following the same schedule. |
|
| The proportion of subjects achieved a clinical response |
Clinical response defined as closure of at least 50% of all treated external openings that were draining at baseline, as clinically assessed |
| 24 weeks,52 weeks and104 weeks |
| The proportion of subjects recurrence | Recurrence defined as the reopening of the closed external openings that had achieved clinical remission after treatment, the appearance of spontaneous fluid drainage, or the presence of fistulas with fluid collections > 2 cm as assessed by enhanced pelvic MRI | 24 weeks,52 weeks and104 weeks |
| Time to achieve clinical remission, clinical response and recurrence | Time to achieve clinical remission, clinical response and recurrence within 24 weeks after drug administration. | 24 weeks,52 weeks and104 weeks |
| The proportion of subjects achieved combined remission | Combined Remission of perianal fistulising Crohn's disease at week 52 and 104 (as defined for week 24) | 52 weeks and104 weeks |
| VAS score | Change from baseline in pain score (VAS score).Total score ranges from 0 to 10. Higher score means more pain | 24 weeks,52 weeks and104 weeks |
| Perianal Disease Activity Index (PDAI) | Change from baseline in Perianal Disease Activity Index (PDAI). Total score ranges from 0 to 20. Higher score means more severe disease | 24 weeks,52 weeks and104 weeks |
| Crohn's Disease Activity Index (CDAI) score | Change from baseline in the Crohn's Disease Activity Index (CDAI) score. Higher score means more severe disease and especially severe disease was defined as a value of greater than 450 | 24 weeks,52 weeks and104 weeks |
| Inflammatory Bowel Disease Questionnaire(IBDQ)score | Change from baseline in IBDQ score. Total score ranges from 32 to 224. Higher score means better quality of life | 24 weeks,52 weeks and104 weeks |
| Anal sphincter function:Wexner incontinence score | Change from baseline in anal sphincter function, Wexner incontinence score,Total score ranges from 0 to 20. Higher score means more severe disease | 24 weeks,52 weeks and104 weeks |
| peripheral blood cytokines | Changes in the levels of peripheral blood cytokines compared to the baseline. | 2 weeks,4 weeks ,8 weeks ,12weeks and 24 weeks |
| D007410 | Intestinal Diseases |