Allogeneic Adipose Tissue Derived Mesenchymal Stromal Cell Therapy for Treating Patients With Severe Respiratory COVID-19. A Danish, Double-blind, Randomized Placebo-controlled Study
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Changes in clinical critical treatment index
研究概览
简要总结
The emerging field of stem cell therapy holds promise of treating a variety of diseases. Especially the mesenchymal stromal cells from bone marrow 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 their ability to evade recognition and actively suppress the immune system.
This knowledge is transferred into studies with COVID-19 patients having severe pulmonary dysfunction, to modify the virus induced immunological and inflammatory activity involved in the progression of disease often leading to prolonged ICU stay and in some occasion's death.
We will conduct a clinical trial in which patients with COVID-19 and severe pulmonary symptoms will be randomized to either placebo or treatment with allogeneic CSCC_ASCs from adipose tissue. The aim is to assess the impact of CSCC_ASCs on the activated immune system and clinical efficacy on pulmonary function.
The perspective is that this new information can be of pivotal importance and potentially be a paradigm shift for the clinical problems and severe outcome seen in some patients with severe COVID-19 and other severe diseases with Acute Respiratory Distress Syndrome.
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 placebo-controlled
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 18-80 years
- •Confirmed HCoV-19 infection
- •Temperature above 38.0o C
- •Pulmonary symptoms and signs, at least one of the following before clinical decision for intubation and respirator treatment:
- •Respiratory distress, RR ≥ 30/min;
- •Oxygen saturation ≤ 93% at rest state;
- •Arterial partial pressure of oxygen (PaO2) / Fraction of inspiration O2 (FiO2) ≤ 300mmHg, 1mmHg=0.133kPa
- •Pneumonia that is judged by chest radiograph or computed tomography
- •In respirator and possible for treatment within the first 24 hours
排除标准
- •Patients that have need for additional immunosuppressive treatment
- •Patients with any past (within the past 3-5 years) or present malignancy (other than excised basal cell carcinoma).
- •Co-Infection with other infectious agent.
- •Females capable of becoming pregnant must have a negative pregnancy test prior to treatment. 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.
- •Patients who are participating in other clinical trials.
研究组 & 干预措施
ASC
100 million allogeneic adipose-derived mesenchymal stromal cell
干预措施: Stem Cell Product (Drug)
Placebo
Saline
干预措施: Stem Cell Product (Drug)
结局指标
主要结局
Changes in clinical critical treatment index
时间窗: day 7 from randomization
次要结局
- Duration of hospitalization(3 months)
- Marker of Immunological function -CD4+ and CD8+ T cell count(3 months)
- Days of respirator treatment(3 months)
- Mortality(3 months)
- Improvement of clinical symptoms including duration of fever and respiratory need(3 months)
- Cytokine profile(3 months)
- Glomerular Filtration Rate(3 months)
- C-reactive protein and leucocyte(3 months)
研究者
JKastrup
Professor MD
Rigshospitalet, Denmark