A Phase I Study of the Safety of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) for Perianal Fistulas in Patients With Crohn's Disease
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- No incidence of treatment-emergent adverse events (TEAEs)
研究概览
简要总结
Objectives:
Primary: To demonstrate the safety of allogeneic UC-MSCs administered by injection for complex perianal fistulas in patients with Crohn's disease
Secondary: To determine the efficacy of a single/multiple allogeneic UC-MSCs injection in improving complex perianal fistula complications and (re-epithelialization of the external openings).
详细描述
Design and Investigation:
Number of Patients: 5 (including a consideration of 20% [1 patient] dropout from the trial)
Dosage and mode of administration Dosage: A total of 60 million PF2020-CELL (UC-MSCs) will be injected locally around the fistula tract, with a separation of 1 cm between injections. All patients will receive a total of 60 million cells per visit for 5 visits, with a 6 - 12 weeks interval between the injections. If the patient is completely healed during any course of stem cell injections, subsequent stem cell treatments can be discontinued. However, patients will still be required to undergo regular follow-up examinations, including physical examinations and other medical tests, until the study is completed.
Mode of administration: The procedure involves localizing the fistulous tract, performing curettage and closing the internal opening, and the injection of PF2020-CELL (UC-MSCs). The indicated dose of PF2020-CELL (UC-MSCs) will be injected starting from the tissues around the internal orifice or orifices and then progressing towards the external opening.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult men and women age 18 years and above.
- •Diagnosis of perianal fistulae associated with Crohn's disease refractory to medical therapy.
- •Presence of perianal fistula(s) with a maximum of 2 internal openings and a maximum of 3 external openings based on clinical assessment.
- •Fit for surgery.
排除标准
- •Informed consent refusal.
- •Pregnancy or breastfeeding women.
- •Current diagnosis of active cancer or remission for less than 5 years.
- •Evidence of active sepsis or significant localised infection.
- •Patients with HIV, HBV, HCV or treponema infection, whether active or latent.
- •Patients with documented allergies.
- •Patients who have received infliximab or any other biologics in the 4 weeks before the cell treatment administration.
- •Patients currently receiving, or having received within 1 month prior to enrollment into this clinical trial, any investigational drug.
- •Patients with any other co-morbidity/ co-pathologies which is deemed as contraindication to stem cells infusion (infection, administration of steroids).
研究组 & 干预措施
PF2020-CELL (UC-MSCs) - Allogeneic Human Umbilical Cord Mesenchymal Stem Cells
A total of 60 million PF2020-CELL (UC-MSCs) will be injected locally around the fistula tract, with a separation of 1 cm between injections. All patients will receive a total of 60 million cells per visit for 5 visits, with a 6 - 12 weeks interval between the injections. If the patient is completely healed during any course of stem cell injections, subsequent stem cell treatments can be discontinued. However, patients will still be required to undergo regular follow-up examinations, including physical examinations and other medical tests, until the study is completed.
干预措施: PF2020-CELL (UC-MSCs) - Allogeneic Human Umbilical Cord Mesenchymal Stem Cells (Biological)
结局指标
主要结局
No incidence of treatment-emergent adverse events (TEAEs)
时间窗: Throughout study completion, an average of 1.5 year
example of TEAEs are pyrexia (non-persistent fever, \<38.5°C), infection, perianal abscess, enlargement of fistula \& allergic reaction.
次要结局
- Clinical healing(Visits 5, 9, 13, 17, 21 (approximately 6 to 12 weeks between visits))