PDA001 for the Treatment of Adults With Moderate-to-Severe Crohn's Disease
| 适应症 | Crohn's Disease |
|---|---|
| 分期 | 2期 |
| 申办方 | Celularity Incorporated |
| 状态 | 已完成 |
| 受试者人数 | 50 人 |
| 干预（药物） | Human Placenta-Derived Cells PDA001 Intravenous Infusion, Vehicle Control |
| 开始日期 | 2010年8月 |
| 完成日期 | 2012年2月 |
| 结果公布日 | 2026年7月7日 |
摘要
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 |
在 BENITIONS 中查看 查看 ClinicalTrials.gov 原文
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