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Application and Research of Mesenchymal Stem Cells in Alleviating Severe Development of COVID-19 Infection

Primary Purpose

COVID-19

Status

Recruiting

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Umbilical cord mesenchymal stem cells implantation

Comparator

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring MSC, COVID-19

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 18-85 years;The diagnosis of COVID-19 infection was clinically classified as Moderate cases, and the criteria were based on Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia(Trial Version 10) Having the relevant clinical manifestations of COVID-19 infection. Having one or more of the following etiological and serological examination results Tested positive for Novel Coronavirus nucleic acid Tested positive for Novel Coronavirus antigen Novel Coronavirus was isolated and cultured positive Novel Coronavirus specific immunoglobulin G reaches a titration of at least 4-fold increase during convalescence compared with the acute phase. Moderate cases diagnostic criteria：Persistent high fever > 3 days or (and) cough, Tachypnea etc，but respiratory rate≧30 breaths/ min ,oxygen saturation > 93% on finger pulse oximeter taken at rest. Radiology shows the characteristic manifestations of COVID-19 pneumonia There are one or more of the following risk factors for the development of severe / critical severity: Patients over 65 years old, especially those who have not been vaccinated against novel coronavirus Patients with cardiovascular and cerebrovascular diseases (including hypertension), chronic lung disease, diabetes, chronic liver and kidney disease, tumors and other underlying diseases, as well as maintenance dialysis Patients with immune deficiency (such as AIDS, long-term use of corticosteroids or other immunosuppressive drugs resulting in immune dysfunction) Patients with Obesity (body mass index ≥30) late trimester of pregnancy and perinatal women Heavy smoker. Exclusion Criteria: Patients with prior or present tumor history,or precancerous lesions confirmed by pathological examination. Patients with active acute myocardial infarction or acute cerebral infarction. Pregnant or lactating patients. Patients with poorly controlled mental illness. Patients addicted to alcohol or drugs. Patients Unable or unwilling to sign informed consent or poor compliance. Patients with active tuberculosis or influenza virus, adenovirus and other acute respiratory virus infection. Patients deemed unsuitable for stem cell therapy by clinicians. Patients enrolled in other clinical trials within 3 months.

Sites / Locations

The First Hospital of Hebei Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

MSCs group

comparator

Arm Description

Patient in Mscs group will receive MSCs implantation by intravenous injection Within 10-15 days of infection

Patients in comparator group will receive placebo treatment Within 10-15 days of infection

Outcomes

Primary Outcome Measures

Effectiveness evaluation

The incidence and clinical status of progression to critical type after the third stem cell transplantation were evaluated

Secondary Outcome Measures

Hospitalization time

The patient's hospital stay in days should be recorded.

oxygenation index（OI）

The oxygenation index of the patient was quantitatively measured in mmHg.

Oxygen saturation（SaO2）

The blood oxygen saturation of patients was monitored by oximeter.

Chest CT

A computed tomography (CT) scan of the patient's chest was performed to evaluate the level of inflammation, the scope of the involvement, and the degree of fibrosis in the heart and lungs.

Pulmonary function evaluation

Lung ventilation experiments were used to measure the lung volume (in ml) and airway patency (in ml) of patients in order to assess their lung function.

Blood biochemical examination

The progression of the lesion was determined by blood chemistry tests on a patient's blood sample, which mostly included liver function: Alanine aminotransferase (U/L)，Glutamic oxaloacetic transaminase (U/L), renal function:blood urea nitrogen (mmol/L) and serum creatinine (umol/L), cardiac function: creatine kinase isoenzymes(U/L) and Troponin(ng/ml), and inflammatory factors: C- reactive protein (mg/dl) and Interleukin- 6(Pg/ml) .

Echocardiographic examination of heart function

Echocardiography was used to evaluate the patient's myocardial contractility, primarily focusing on left ventricular ejection fraction (LVEF).

Safety assessment

infusion and allergic reactions, life-threatening adverse events

Full Information

NCT ID

NCT05741099

First Posted

February 10, 2023

Last Updated

February 22, 2023

Sponsor

Hebei Medical University

1. Study Identification

Unique Protocol Identification Number

NCT05741099

Brief Title

Application and Research of Mesenchymal Stem Cells in Alleviating Severe Development of COVID-19 Infection

Official Title

The Application and Research of Mesenchymal Stem Cells in Alleviating the Severe Development of Novel Coronavirus Infection to Clarify Its Safety and Effectiveness.

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 28, 2023 (Actual)

Primary Completion Date

January 2024 (Anticipated)

Study Completion Date

January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hebei Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study is to evaluate the safety and efficacy of umbilical cord mesenchymal stem cells Therapy for COVID-19.

Detailed Description

Since 2019, novel coronavirus Disease 2019 (COVID-19) has spread and prevailed all over the world. COVID-19 has a wide range of clinical manifestations of respiratory and non-respiratory symptoms, including mild or severe influenza-like syndrome, respiratory distress or respiratory failure, and may end in multiple organ failure. Mesenchymal stem cells (MSCS) are considered as ideal seed cells for the treatment of various diseases due to their unique immune regulation, self-renewal and multiple differentiation potentials. The safety of MSC transplantation in the treatment of COVID-19 patients has been proved by a number of clinical studies, and has shown good clinical efficacy in shortening the course of the disease, alleviating lung damage, and reducing the level of inflammatory factors. However, previous clinical studies mainly focused on the efficacy of MSC transplantation in critically ill patients of COVID-19, ignoring the important role of cell transplantation in delaying or preventing COVID-19 's progress and preventing reinfection.COVID-19 has spread throughout the country and even the world, and the increase in severe and critical cases has caused a great impact on national medical and health resources. Stem cell transplantation offers new treatment ideas for COVID-19 patients. Since the role of cell transplantation in delaying or preventing the progression of light and medium novel coronavirus infection and preventing reinfection has not been clearly reported, this study intends to use MSC transplantation to evaluate the role of stem cells in the occurrence and development of novel coronavirus infection, so as to provide an important reference for the prevention and treatment of COVID-19 by MSC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19

Keywords

MSC, COVID-19

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

MSCs group

Arm Type

Experimental

Arm Description

Patient in Mscs group will receive MSCs implantation by intravenous injection Within 10-15 days of infection

Arm Title

comparator

Arm Type

Placebo Comparator

Arm Description

Patients in comparator group will receive placebo treatment Within 10-15 days of infection

Intervention Type

Biological

Intervention Name(s)

Umbilical cord mesenchymal stem cells implantation

Intervention Description

Patient in Mscs group will receive MSCs implantation by intravenous injection.

Intervention Type

Other

Intervention Name(s)

Comparator

Intervention Description

Patients in comparator group will receive placebo treatment

Primary Outcome Measure Information:

Title

Effectiveness evaluation

Description

The incidence and clinical status of progression to critical type after the third stem cell transplantation were evaluated

Time Frame

Within 1 year of receiving mesenchymal stem cell transplants

Secondary Outcome Measure Information:

Title

Hospitalization time

Description

The patient's hospital stay in days should be recorded.

Time Frame

Time period from patient admission to discharge

Title

oxygenation index（OI）

Description

The oxygenation index of the patient was quantitatively measured in mmHg.

Time Frame

At the time of our patient's hospitalization and 7 days after receiving the third MSC transplant.

Title

Oxygen saturation（SaO2）

Description

The blood oxygen saturation of patients was monitored by oximeter.

Time Frame

At the time of our patient's hospitalization and 7 days after receiving the third MSC transplant.

Title

Chest CT

Description

A computed tomography (CT) scan of the patient's chest was performed to evaluate the level of inflammation, the scope of the involvement, and the degree of fibrosis in the heart and lungs.

Time Frame

At admission, before to the stem cell transplant, and at 1 month, 6 months, and 12 months following the third MSC transplant.

Title

Pulmonary function evaluation

Description

Lung ventilation experiments were used to measure the lung volume (in ml) and airway patency (in ml) of patients in order to assess their lung function.

Time Frame

At admission, before to the stem cell transplant, and at 1 month, 6 months, and 12 months following the third MSC transplant.

Title

Blood biochemical examination

Description

Time Frame

At admission, before to the stem cell transplant, and at 1 month, 6 months, and 12 months following the third MSC transplant.

Title

Echocardiographic examination of heart function

Description

Echocardiography was used to evaluate the patient's myocardial contractility, primarily focusing on left ventricular ejection fraction (LVEF).

Time Frame

At admission, before to the stem cell transplant, and at 1 month, 6 months, and 12 months following the third MSC transplant.

Title

Safety assessment

Description

infusion and allergic reactions, life-threatening adverse events

Time Frame

Within 1 year of receiving mesenchymal stem cell transplants

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xianyun Wang, Doctor

Phone

031187156290

wangxianyun_mbb@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xifeng Jiang, Doctor

Organizational Affiliation