Treatment With Mesenchymal Stem Cells for Severe Corona Virus Disease 2019(COVID-19)
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|ClinicalTrials.gov Identifier: NCT04288102|
Recruitment Status : Recruiting
First Posted : February 28, 2020
Last Update Posted : April 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Corona Virus Disease 2019(COVID-19)||Biological: MSCs Biological: Saline containing 1% Human serum albumin（solution of MSC）||Phase 2|
The epidemic of 2019 novel coronavirus (causing the disease Covid-19) has expanded from Wuhan throughout China and is being exported to a growing number of countries, some of which have seen onward transmission. COVID-19 caused clusters of severe respiratory illness and was associated with 2% mortality. There is currently no vaccine and no specific antiviral treatment recommended for COVID-19. About 20% of the patients were severe and the mainstay of clinical management is largely symptomatic treatment, with organ support in intensive care for seriously ill patients. Therefore, it is urgent to find a safe and effective therapeutic approach to COVID-19.
In the last years, the promising features of mesenchymal stem cells (MSCs), including their regenerative properties and ability to differentiate into diverse cell lineages, have generated great interest among researchers whose work has offered intriguing perspectives on cell-based therapies for various diseases. These findings seem to highlight that the beneficial effect of MSC-based treatment could be principally due by the immunomodulation and regenerative potential of these cells. MSCs could significantly reduce the pathological changes of lung and inhibit the cell-mediated immune inflammatory response induced by influenza virus in animal model . MSCs has been shown to reduce nonproductive inflammation and affect tissue regeneration and is being evaluated in patients with ARDS. Our phase I preliminary data of parallel assignment study(NCT04252118) showed that three doses of MSCs was safe in patients with COVID-19. Randomized control trial is needed to assess efficacy and safety.
The investigators will do a prospective, double-blind, multicentre, randomised trial to assess treatment with three intravenous doses of MSCs compared with placebo. 90 severe COVID-19 patients will be recruited in China. 60 patients will receive i.v. transfusion 3 times of MSCs（ 4.0*10E7 cells per time) and the conventional treatment as the treated group. In addition, the 30 patients will receive placebo and conventional treatment as control group.
Size of lesion area and severity of pulmonary fibrosis by chest CT,mMRC (Modified Medical Research Council) dyspnea scale, 6-minute walk test, maximum vital capacity (VCmax), Diffusing Capacity (DLCO), oxygen saturation, oxygenation index, duration of oxygen therapy, side effects, immunological characteristics (immune cells, inflammatory factors, etc.) will be evaluated during the 90 days follow up.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized, double-blind, placebo-controlled study|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Human Mesenchymal Stem Cells in Combination With Standard Therapy in the Treatment of COVID-19 Patients With Severe Convalescence|
|Actual Study Start Date :||March 5, 2020|
|Estimated Primary Completion Date :||July 15, 2020|
|Estimated Study Completion Date :||July 31, 2020|
Experimental: Mesenchymal Stem Cells (MSCs)
Conventional treatment plus MSCs Participants will receive conventional treatment plus 3 times of MSCs
3 times of MSCs(4.0*10E7 cells per time) intravenously at Day 0, Day 3, Day 6.
Placebo Comparator: Placebo
Conventional treatment plus placebo Participants will receive conventional treatment plus 3 times of placebo
Biological: Saline containing 1% Human serum albumin（solution of MSC）
3 times of placebo（intravenously at Day 0, Day 3, Day 6）
- Size of lesion area and severity of pulmonary fibrosis by chest CT [ Time Frame: At Baseline , Day 6, Day 10, Day 14, Day 28 and Day 90 ]Evaluation of Pneumonia Improvement
- mMRC (Modified Medical Research Council) dyspnea scale [ Time Frame: Baseline , Day 7, Day 14, Day 28, Day 90 ]
Evaluation of Pneumonia Improvement
No limitation of activities, discharged from hospital =Score 1; Hospitalized, no oxygen therapy=Score 2; Oxygen by mask or nasal prongs-Score 3; Non-invasive ventilation or high-flow oxygen=Score 4; Mechanical ventilation or ECMO=Score 5; Death=Score 6.
- Oxygenation index( PaO2/FiO2) [ Time Frame: Baseline , Day 7, Day 14, Day 28, Day 90 ]Evaluation of Pneumonia Improvement
- Duration of oxygen therapy(days) [ Time Frame: Day 28, Day 90 ]Evaluation of Pneumonia Improvement
- Duration of hospitalization(days) [ Time Frame: Day 28, Day 90 ]Evaluation of Pneumonia Improvement
- Blood oxygen saturation [ Time Frame: Baseline , Day 7, Day 14, Day 28, Day 90 ]Evaluation of Pneumonia Improvement
- CD4+ T cell count and cytokine level [ Time Frame: Baseline , Day 6, Day 10, Day 14, Day 21, Day 28, Day 90 ]Marker of Immunological function
- Side effects in the MSCs treatment group [ Time Frame: Baseline , Day 3, Day 6，Day 10, Day 14, Day 21, Day 28, Day 90 ]Proportion of participants with treatment-related adverse events as assessed by CTCAE v4.0
- 6-minute walk test [ Time Frame: Baseline, Day 10, Day 14, Day 21, Day 28, Day 90 ]Evaluation of Pneumonia Improvement
- Maximum vital capacity (VCmax) [ Time Frame: Baseline, Day 10, Day 14, Day 21, Day 28, Day 90 ]Evaluation of Pneumonia Improvement
- Diffusing Capacity (DLCO) [ Time Frame: Baseline, Day 10, Day 14, Day 21, Day 28, Day 90 ]Evaluation of Pneumonia Improvement
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04288102
|Contact: Lei Shi, MD,PhDemail@example.com|
|Contact: Fu-Sheng Wang, MD,PhDfirstname.lastname@example.org|
|Maternal and Child Hospital of Hubei Province||Recruiting|
|Wuhan, Hubei, China, 430000|
|Contact: Weifen Xie, MD, PhD|
|Wuhan Huoshenshan Hospital||Recruiting|
|Wuhan, Hubei, China, 430000|
|Contact: Lei Shi, MD, PhD email@example.com|
|Study Chair:||Fu-Sheng Wang, MD, PhD||The fifth medical center of PLA general hospital|