A Phase 1 clinical trial of intravenous administration of mesenchymal stem cells derived from umbilical cord and placenta in patients with novel COVID-19 virus pneumonia.
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- 1. Avoidance of -
研究概览
简要总结
This is a phase 1 safety study to be conducted in patients with novel Covid 19 virus pneumonia administered with mesenchymal stem cells derived from umbilical cord and placenta. This product is manufactured in a cGMP facility, licensed by CDSCO and FDA.The product has undergone all mandatory preclinical and characterization studies and analysis and is approved for use in humans to treat COVID-19 afflicted patients by CDSCO/DCG(I) as per the New Drugs and Clinical Trial Rules, 2019.
The study will be conducted in 20 patients. The dosage administered will be 100 million cells in 10 patients and 200 million cells in 10 patients in two doses on day 1 and day 4 along with standard care. Safety and efficacy of the MSCs will be studied as primary and secondary end points.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients admitted with RT-PCR confirmed COVID-19 illness.
- •Age: 18-65 years without any uncontrolled comorbidities like hypertension, diabetes, renal failure, etc Written informed consent Has any of the two PaO2/ FiO2: 200-300 Respiratory Rate > 24/min and SaO2 ≤ 93% on room air.
排除标准
- •Pregnant women Breastfeeding women Critically ill patients: P/F ratio < 200 (ARDS ) Shock (Requiring Vasopressor to maintain a MAP ≥ 65mmHg or MAP below 65) Patients with other severe co-morbidities like cancer, chronic renal, chronic liver failure and chronic cardiac failure.
- •This will not include diabetes, hypertension, etc Participating in any other clinical trial.
结局指标
主要结局
1. Avoidance of -
时间窗: All Days
Progression to severe ARDS (P/F ratio 100) and All-cause Mortality at 28 days
时间窗: All Days
2. Oxygenation Index : SpO2
时间窗: All Days
3. Multi Organ Function: CBC,LFT,Serum Creatinine,Electrolytes,
时间窗: All Days
4. Troponin and Myoglobin
时间窗: All Days
5. Clinical measures: Fever and Respiratory Rate
时间窗: All Days
6.Immediate Adverse Events occurring after IV administration of MSCs
时间窗: All Days
7. Other adverse events e.g. Pulmonary embolism, Stroke, Arrhythmias, Liver failure
时间窗: All Days
次要结局
- Time to recovery on 8 Point ordinal scale(Time to symptom resolution (Fever, Cough, Shortness of Breath))