Repairing Peri-Anal Fistulas With Regenerative Cell Therapeutics
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Healing rate (percentage)
研究概览
简要总结
This clinical study aims to evaluate the outcome of the treatment of complex perianal fistulas (PAF) by the combination of minimal surgical debridement with regenerative cellular therapeutics.
详细描述
After being informed about the study and potential risks, all patients giving written informed consent will undergo screening serology and preoperative work-up to determine eligibility for study entery. Patients who meet the eligibility requirements will be treated for their fistulas by combined minor surgical debridement of the fistula tract and closure of the internal orifice as well as liposuction from the abdominal wall. Regenerative cells- enriched lipoaspirate will be injected around the entire length of the fistula tract. The first five patients will receive their own regenerative cells and act as donors for the next included patients, but they will not be included in the final analysis. The rest of the included patients (70) will be randomized in double-blinded manner (participant and investigator) in a 1:1 ratio to either recieve own regenerative cells (ADRC Adipose-Derived Regeneative Cells) or donated cultured regenerative cells (ADRC001). All included patients will be scheduled for follow-up at 3, 6 and 12 months after treatment.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Autologous ADRC
Allocated patients will be treated for the fistula by combined surgical debridement of the fistula tract, closure of the internal orifice and injection of 30 ml lipoaspirate around the entire length of the fistula tract. Lipoaspirate will be harvested from the anterior abdominal wall under the same operation. Two hours later, the patient will receive injection of 5 ml suspension including 30 million autologous adipose-derived regenerative cells ADRC and injected at the same site of the lipoaspirate injection.
干预措施: ADRC injection (Drug)
allogenic ADRC001
Allocated patients will be treated for the fistula by combined surgical debridement of the fistula tract, closure of the internal orifice and injection of 30 ml lipoaspirate around the entire length of the fistula tract. Lipoaspirate will be harvested from the anterior abdominal wall under the same operation. Two hours later, the patient will receive injection of 5 ml suspension including 30 million cultured allogenic adipose-derived regenerative cells ADRC001 and injected at the same site of the lipoaspirate injection.
干预措施: ADRC001 injection (Drug)
结局指标
主要结局
Healing rate (percentage)
时间窗: at 6 and 12 months follow-up
Clinical healing is defined as closure of the external opening(s), absence/cessation of discharge and swelling by palpation.
次要结局
- QoL(at12 months follow-up.)
- Transplantation-related alloantibodies(at12 months follow-up.)
- Fecal Incontinence(at12 months follow-up.)
- Risk factors for recurrence of fistula.(at12 months follow-up.)
- Radiological healing.(at12 months follow-up.)
- Treatment efficacy.(at12 months follow-up.)
- Cellular composition(at 3 months follow-up.)
研究者
Karam Matlub Sørensen, PhD
Primary Investigator (PI)
University of Southern Denmark