Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03279081 | Study to Assess Efficacy and Safety of Cx601, Adult Allogeneic Expanded Adipose-derived Stem Cells (eASC) for the Treatment of Complex Perianal Fistula(s) in Participants With Crohn's Disease (CD) | PHASE3 | COMPLETED | 568 | — | — | Sep 15, 2017 | Jul 26, 2023 | Sep 19, 2024 | 159 | United States, Belgium +13 |
| NCT01541579 | Adipose Derived Mesenchymal Stem Cells for Induction of Remission in Perianal Fistulizing Crohn's Disease | PHASE3 | COMPLETED | 278 | — | — | Jul 1, 2012 | Nov 1, 2016 | Nov 29, 2019 | 52 | Austria, Belgium +6 |
Combined remission was defined as the closure of all treated external openings that were draining at baseline despite gentle finger compression and absence of collection(s) \>2 cm (in at least 2 dimensions) of the treated perianal fistula(s) confirmed by blinded central magnetic resonance imaging (MRI) assessment. Percentages are rounded off to whole number at the nearest decimal.
Combined Remission of perianal fistulising Crohn's disease defined as the clinical assessment of closure of all treated external openings (EO) that were draining at baseline despite gentle finger compression at week 24, and absence of collections \> 2 cm of the treated perianal fistulas confirmed by centrally blinded MRI assessment by week 24.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo (saline) 24 milliliters (mL) was administered once by local injection. |
| Cx601 | EXPERIMENTAL | Cx601 expanded adipose-derived stem cells (eASCs) 120 million cells (5 million cells per mL) was administered once by local injection. |
| Treatment Arm | EXPERIMENTAL | Cx601 is a cell suspension in aseptic buffered solution containing human expanded adipose-derived stem cells (eASCs) 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. |
| Placebo-control group | PLACEBO_COMPARATOR | Placebo (saline solution) will be given also for intralesional injection at the same quantity (volume, 24 mL) and following the same schedule. |
| Name | Type | Description |
|---|---|---|
| Cx601 | DRUG | Cx601 eASCs intralesional injection. |
| Placebo | OTHER | Cx601 placebo-matching eASCs intralesional injection. |
| Saline solution | OTHER | 24 mL saline solution by intralesional injection |
Inclusion Criteria: 1. Signed informed consent. 2. Participants of either gender greater than or equal to (\>=) 18 years and less than or equal to (\<=) 75 years of age. 3. Participants with CD diagnosed at least 6 months prior to Screening visit in accordance with accepted clinical, endoscopic, hi...