NCT01769755已完成1 期
A Randomized, Double-Blind, Placebo-Controlled Dose Escalation Study to Determine the Safety and Efficacy of Intravenous Infusion of Human Placenta-Derived Cells (PDA001) for the Treatment of Crohn's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 12
- 主要终点
- Adverse Events
研究概览
简要总结
To assess the safety and efficacy of intravenous (IV) PDA001 infused every two weeks for up to 5 total infusions in subjects with Crohn's disease who are refractory to one or more standard Crohn's disease therapies.
详细描述
This is a randomized, double-blind, placebo-controlled, dose-escalation study to study 3 cohorts of subjects with Crohn's Disease including (but not limited to) those with colonic involvement. Each cohort (n = 9) will include PDA001 treated subjects (n = 6) as well as placebo (vehicle control) treated subjects (n = 3). Cohorts will be enrolled sequentially, beginning with the lowest dose cohort (1/4 unit PDA001) and progressing until the maximum tolerated dose of IV PDA001 is determined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Males and females 18 - 75 years of age at the time of signing the informed consent document.
- •Minimum weight of subject is 40 kg at screening.
- •Subject must have inflammatory Crohn's Disease (CD) diagnosed at least 6 months but no greater than 15 years prior to treatment with Investigational Product (IP).
- •Subject must have confirmation of ongoing CD by ileocolonoscopy at screening.
- •Subject must have a Crohn's Disease Activity Index (CDAI) score ≥ 220 and ≤ 450 as assessed between Visit 1 and Visit 2.
排除标准
- •Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study including but not limited to
- •Liver Function Tests Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) > 2.5 x the upper limit of normal at screening.
- •Serum creatinine concentration > 2.0 mg/dl at screening. Alkaline phosphatase > 2.5 x the upper limit of normal at screening.
- •Bilirubin level > 2 mg/dL (unless subject has known Gilbert's disease).
- •Pregnant or lactating females.
- •Morbidly obese subjects Body Mass Index (BMI) > 35 at screening).
- •Subject has untreated chronic infection including Clostridium difficile toxin positive at screening or treatment of any infection with antibiotics within 4 weeks prior to dosing with IP (other than a treated urinary tract infection or drained perianal abscess). Note: Stable doses of antibiotics used to treat Crohn's Disease are allowed.
- •Subject has organic heart disease (eg, congestive heart failure), clinically significant arrhythmia or clinically significant abnormal findings on Electrocardiograms (ECG).
- •Subject has a history of other malignancies within 5 years (except basal cell carcinoma of the skin that is surgically cured, remote history of cancer now considered cured or positive Pap smear with subsequent negative follow up).
- •Subject has had a stricture of the bowel requiring hospitalization within 182 days prior to treatment with IP.
- •Subject has had bowel surgery other than perianal (for example, fistulotomy, seton placement, or abscess drainage) or previous abscess drainage within 182 days prior to treatment with IP.
- •Subject has had any surgery within 28 days prior to treatment with IP.
- •Subject has a colostomy, ileostomy or ileal pouch anal anastomosis.
- •Subject has received an investigational agent -an agent or device not approved by FDA for marketed use in any indication-within 90 days (or 5 half-lives, whichever is longer) prior to treatment with investigational product.
- •Subject has received previous cell therapy.
- •Subject is expecting to have elective surgery at any time between Visit 1 (screening) and Visit 7 (end of induction phase).
- •Subject has concurrent diagnosis of ulcerative colitis.
- •Subjects with protein C or S deficiency.
- •Subjects with prior history of thrombophlebitis or other pathological arterial or venous thrombosis.
研究组 & 干预措施
Human Placenta-Derived Cells PDA001 Intravenous Infusion
Experimental
Intravenous infusion of Human Placenta-Derived Cells PDA001 over the course of 2 hours.
干预措施: PDA001 (Biological)
Vehicle controlled placebo
Placebo Comparator
Intravenous infusion of Vehicle Controlled Placebo over the course of 2 hours
干预措施: Vehicle Controlled Placebo (Drug)
结局指标
主要结局
Adverse Events
时间窗: Up to 1 year
Number of participants experiencing adverse events during the initial and extended follow-up periods
次要结局
- Clinical Response(Up to 1 year)
- Clinical Remission(Up to 1 year)
研究者
研究点 (12)
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