Intermediate Size Expanded Access for the Use of ExoFlo in the Treatment of Abdominal Solid Organ Transplant Patients Who Are at Risk of Worsening Allograft Function With Conventional Immunosuppressive Therapy Alone
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
- 试验地点
- 1
研究概览
简要总结
This Expanded Access Protocol will provide access to the IMP ExoFlo for patients who have severe or life-threatening abdominal solid organ transplant rejection or who are evaluated and determined to be at high risk of progression to severe or life-threatening condition related to rejection of an abdominal solid organ transplant, at risk of worsening allograft function, or at risk of complications from current immunosuppressive therapeutic regimens.
详细描述
Objectives:
The primary objective of this expanded access program is to evaluate safety and tolerability of ExoFlo in patients with graft inflammation, or worsening graft function, or evidence of rejection of an abdominal solid organ transplant despite conventional therapies. The secondary objective is to characterize the improvement seen in serum inflammatory markers and inflammation of solid abdominal organ.
Endpoints:
Primary Endpoint:
Incidence of AEs or SAEs.
研究设计
- 研究类型
- Expanded Access
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
- •Provision of signed and dated informed consent form.
- •Stated willingness to comply with all study procedures and availability for the duration of the study.
- •Male or female, ages 18 to
- •Previous abdominal solid organ transplant, including intestinal transplant.
- •Diagnosis of acute or chronic rejection / inflammation based on clinical observations, laboratory analysis, histological evaluation.
- •Diagnosis of worsening allograft function based on clinical observations, laboratory analysis, histological evaluation.
- •Failed primary and alternate standard of care therapies.
- •Serious or life-threatening condition or progressing to serious or life-threatening condition if not treated as evaluated by the treating physician.
- •In otherwise good general health as evidenced by medical history.
- •Male or female of reproductive potential must utilize a medically effective birth control method during from time of enrollment to 6 months after last dose of IMP.
排除标准
- •Pregnant or breastfeeding.
- •Treatment with another investigational drug or other intervention within 30 days of enrollment.