A Danish, Single Centre, Double-blind, Randomized Study Evaluating Allogeneic Adipose Tissue Derived Mesenchymal Stromal Cell Therapy to Reduce Primary Graft Dysfunction After Lung Transplantation
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pulmonary graft dysfunction (PDG)
研究概览
简要总结
To investigate safety of treatment with allogeneic adipose tissue-derived mesenchymal stromal cells (ASCs) in patients undergoing lung transplantation, to evaluate whether the treatment can reduce host immunological reaction towards the graft, and to reduce the ischemic reperfusion-injury after transplantation.
详细描述
The emerging field of stem cell therapy holds promise of treating a variety of diseases. Especially the mesenchymal stromal cells from bone marrow (BMSCs) or adipose tissue (ASCs) have proven their potential for regenerative therapy in patients with ischemic heart disease. Both of these cell types have putative immunomodulatory properties, as they have demonstrated to actively suppress the immune system and hereby evade recognition.
This knowledge will be transferred into studies in the ischemic reperfusion-injury/primary lung graft dysfunction in lung transplantation, and in suppressing the initial host immunological response towards the transplanted lung where a high degree of immunological and inflammatory activity is involved.
We will conduct a clinical trial in which patients receiving lung transplantation will be randomized to either placebo or treatment with allogeneic MSCs from adipose tissue. The aim is to assess the impact of MSCs on primary graft dysfunction.
The perspective is that this new information can be of pivotal importance and potentially be a paradigm shift for the clinical problems seen in the first period after lung transplantation and reduce the long-term graft rejection and dysfunction.
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)
盲法说明
Double-blind
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female lung recipients 18-70 years of age undergoing primary double (including size reduction) lung transplantation.
- •Patient willing and capable of giving written informed consent for study participation and anticipated to be able to participate in the study for 3 months.
排除标准
- •Recipients of multi-organ transplant, and or previously transplanted with any solid organ, including previous lung transplantation.
- •Patients scheduled for single lung transplantation.
- •Patients in need of acute transplantation e.g. patients on urgent call for transplantation and patients on respirator or on extra corporal membrane oxygenation (ECMO) treatment at time of transplantation.
- •Patients that based on crossmatch prior to transplantation have need for additional immunosuppressive treatment
- •Donor lung cold ischemic time > 12 hours.
- •Patients with platelet count < 50,000/mm3 at the evaluation before transplantation.
- •Patients who are unlikely to comply with the study requirements.
- •Patient unable to participate in the study for the full study period
- •Patients with any past (within the past 3-5 years) or present malignancy (other than excised basal cell carcinoma).
- •Females capable of becoming pregnant must have a negative pregnancy test prior to transplantation. After inclusion, they must use contraceptives for 2 months following the given stem cell treatment. The pill, spiral, depot injection of progesterone, sub-dermal implantation, hormonal vaginal ring and transdermal patch regarded as safe contraceptives.
研究组 & 干预措施
Infusion of 100 million ASC
Infusion of 100 million adipose derived mesenchymal stromal cells from healthy donors
干预措施: adipose derived mesenchymal stromal cells (Drug)
Infusion of 200 million ASC
Infusion of 200 million adipose derived mesenchymal stromal cells from healthy donors
干预措施: adipose derived mesenchymal stromal cells (Drug)
Infusion of placebo
Infusion of saline
干预措施: Saline (Drug)
结局指标
主要结局
Pulmonary graft dysfunction (PDG)
时间窗: 3 days after treatment
Difference in presence or not presence of Primary graft dysfunction (PGD) after transplantation in ASC treated patients compared to controls. Primary graft dysfunction is defined, according to the International Society for Heart and Lung Transplantation (ISHLT), as presence of both pulmonary infiltrates and hypoxemia occurring within the first 72 hours after transplantation
次要结局
- Kidney glomerular Filtration Rate(12 weeks after treatment)
- Inflammatory markers(through the 12 weeks)
研究者
JKastrup
MD professor
Rigshospitalet, Denmark