PDA001 for the Treatment of Adults With Moderate-to-Severe Crohn's Disease
| Condition | Crohn's Disease |
|---|---|
| Phase | Phase 2 |
| Sponsor | Celularity Incorporated |
| Status | Completed |
| Enrollment | 50 participants |
| Interventions | Human Placenta-Derived Cells PDA001 Intravenous Infusion, Vehicle Control |
| Start date | Aug, 2010 |
| Completion date | Feb, 2012 |
| Results posted | Jul 7, 2026 |
Summary
This Phase 2a study evaluated the efficacy, safety, and tolerability of intravenous human placenta-derived cells (PDA001) compared with placebo in adults with moderate-to-severe Crohn's disease. Three PDA001 dose levels were evaluated.
Percentage of Subjects With Clinical Response Based on Crohn's Disease Activity Index (CDAI) at Both Week 4 and Week 6
| 200 × 10^6 Cells of Human Placenta-Derived Cells PDA001 | 5 Participants |
|---|---|
| 800 × 10^6 Cells of Human Placenta-Derived Cells PDA001 | 5 Participants |
| Vehicle Control | 0 Participants |
| 1.6 × 10^9 Cells of Human Placenta-Derived Cells PDA001 | 2 Participants |
Open in BENITIONS View on ClinicalTrials.gov
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