NCT04869397终止2 期
Treatment of Respiratory Complications Associated With COVID-19 Infection Using Wharton's Jelly (WJ)-Umbilical Cord (UC) Mesenchymal Stromal Cells (ProTrans®): a Randomized Phase II Controlled Clinical Trial
McGill University Health Centre/Research Institute of the McGill University Health Centre1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2021年6月14日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Composite endpoint
研究概览
简要总结
This is a randomized phase II placebo controlled clinical trial. Active arm: Allogeneic Wharton's jelly derived MSCs (WJ-MSCs). Both groups will receive standard of care treatment for COVID (e.g. dexamethasone)
详细描述
Allogeneic Wharton's jelly-MSCs (WJ-MSC) will be provided by NextCell Pharma under the commercial name of ProTrans®. ProTrans® will be administered at a fixed dose of 100 million cells per patient in a single infusion at bedside.
Placebo: Sodium chloride buffer supplemented with 5% HSA and 10% DMSO same volume and mode of administration as treatment group (NextCell Pharma).
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
- Double (Participant, Investigator)
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
- •Male or female, aged 18 years-old or older
- •Laboratory-confirmed SARS-CoV-2 infection determined by reverse-transcription polymerase chain reaction (RT-PCR) prior to randomization
- •Hospitalized patients
- •Severe COVID-19 pneumonia defined as patients who cannot saturate > 96% on 4 L/min but are NOT on "non-invasive" ventilation nor invasive mechanical ventilation nor Extracorporeal membrane oxygenation (ECMO). Patients on high flow would be eligible if they receive treatment in a non-critical care unit only.
- •Use of contraception or acceptable birth control for the duration of the study in women of childbearing potential
- •Provision of written or verbal informed consent by the patient or designated substitute decision maker
排除标准
- •Inability to provide informed consent
- •Patients expected to survive less than 24 hours
- •Advanced directives of patient's wishes to refuse intubation.
- •Patients on mechanical ventilation
- •Pregnant women [pregnancy defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotrophin (hCG) laboratory test]
- •Breastfeeding
- •Weight > 100 kg or < 50 kg
- •Cancer not in remission or active serious illness unrelated to COVID-
- •Any of the following laboratory results at screening: Absolute neutrophil count (ANC) ≤ 1.0 x 109/L, Platelets (PLT) < 50 G /L, Alanine transaminase (ALT) or Aspartate transaminase (AST) > 5N, eGFR < 30 mL/min
- •Current documented bacterial infection
- •Known infection with Human immunodeficiency virus, Treponema pallidum, Hepatitis B antigen (serology consistent with previous vaccination and a history of vaccination is acceptable) or Hepatitis C
- •On-going therapy against tuberculosis, or exposed to tuberculosis or have travelled in areas with high risk of tuberculosis or mycosis within the last 3 months
- •Known allergies to a component of the ProTrans® product
- •Pre-existing chronic respiratory diseases requiring long-term oxygen therapy or severe pulmonary hypertension (PAPS >30 mm HG) or pulmonary fibrosis
- •Pre-existing cirrhosis with basal Child and Pugh of C
研究组 & 干预措施
Allogeneic Wharton's jelly-MSCs (WJ-MSC)
Experimental
Intravenous administration, 1 dose, for 20 minutes
干预措施: Allogeneic Wharton's jelly-MSCs (WJ-MSC) (Biological)
Placebo
Placebo Comparator
Intravenous administration, 1 dose, for 20 minutes
干预措施: Placebo (Other)
结局指标
主要结局
Composite endpoint
时间窗: at 15 days after intervention
rate of use of mechanical ventilation (i.e. need for intubation) or death
次要结局
- Clinical status evaluation assessed by the 9-point ordinal scale(day 7, 15 and 30)
- Survival(day 7, 15 and 30)
- Time to clinical improvement assessed by the 9-point ordinal scale(time from randomization to either an improvement of 1 point on the 9-point ordinal scale or discharge from hospital)
- Duration of hospitalization and ICU stay(From enrolment to discharge or ICU transfer or death)
研究者
Ines Colmegna
Senior Researcher
McGill University Health Centre/Research Institute of the McGill University Health Centre
研究点 (1)
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