Clinical Research of Human Mesenchymal Stem Cells in the Treatment of COVID-19 Pneumonia

NCT04339660 | Unknown Phase 1 DMC

• 1 other identifier: Pr20200402
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The COVID-19 pneumonia has grown to be a global public health emergency since patients were first detected in Wuhan, China, in December 2019, which spread quickly to worldwide and presented a serious threat to public health. It is mainly characterized by fever, dry cough, shortness of breath and breathing difficulties. Some patients may develop into rapid and deadly respiratory system injury with overwhelming inflammation in the lung. Currently, no specific drugs or vaccines are available to cure the patients with COVID-19 pneumonia. Hence, there is a large unmet need for a safe and effective treatment for COVID-19 pneumonia patients, especially the critically ill cases. The significant clinical outcome and well tolerance was observed by the adoptive transfer of allogenic MSCs. We proposed that the adoptive transfer therapy of MSCs might be an ideal choice to be used. We expect to provide new options for the treatment of critically ill COVID-19 pneumonia patients and contribute to improving the quality of life of critically ill patients.

Conditions

COVID-19

Keywords

COVID-19; UC-MSCs; critically ill; cell transplantation

Outcome Measures

Primary Outcomes (2)

• The immune function (TNF-α 、IL-1β、IL-6、TGF-β、IL-8、PCT、CRP)

  Improvement and recovery time of inflammatory and immune factors

  Observe the immune function of the participants within 4 weeks

• Blood oxygen saturation

  Evaluation of Pneumonia change

  Monitor blood oxygen saturation of the participants within 4 weeks

Secondary Outcomes (6)

• Rate of mortality within 28-days

  At baseline, Day 1, Day 2, Day 7, Week 2, Week 3, Week 4

• Size of lesion area by chest imaging

  At baseline, Day 1, Day 2, Day 7, Week 2, Week 3, Week 4

• CD4+ and CD8+ T cells count

  At baseline, Day 1, Day 2, Day 7, Week 2, Week 3, Week 4

• Peripheral blood count recovery time

  At baseline, Day 1, Day 2, Day 7, Week 2, Week 3, Week 4

• Duration of respiratory symptoms (fever, dry cough, difficulty breathing, etc.)

  At baseline, Day 1, Day 2, Day 7, Week 2, Week 3, Week 4

Study Arms (2)

UC-MSCs treatment group

EXPERIMENTAL

Participants will receive conventional and treatment with MSCs, MSCs were suspended in 100 mL of normal saline, and the total number of transplanted cells was calculated by 1\*10E6 cells per kilogram of weight. This product is generally a course of treatment, a total of 1 time, depending on the condition of the need to be given again at an interval of 1 week.

Biological: UC-MSCs

Control group

PLACEBO COMPARATOR

Participants will receive conventional treatment and Placebo intravenously.

Other: Placebo

Interventions

UC-MSCs BIOLOGICAL

1\*10E6 UC-MSCs /kg body weight suspended in 100mL saline

UC-MSCs treatment group

Placebo OTHER

100mL saline intravenously

Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, 18 years old ≤ age ≤ 75years old;
• CT image is characteristic of 2019 novel coronavirus pneumonia;
• Laboratory confirmation of 2019-nCoV infection by reverse transcription polymerase chain reaction (RT-PCR);
• In compliance with the 2019-nCoV pneumonia diagnosis standard (according to the novel coronavirus infection pneumonia diagnosis and treatment program (Trial Implementation Version 6) issued by the National Health and Medical Commission, and WHO 2019 new coronavirus guidelines standards): (A) increased breathing rate (≥30 beats / min), difficulty breathing, cyanosis of the lips; (B) in resting state, means oxygen saturation ≤93%; (C) partial pressure of arterial oxygen (PaO2) / Fraction of inspired oxygen (FiO2) ≤300 mmHg (1mmHg = 0.133kPa);
• Participant or the authorized agent signed the informed consent form.
• Agree to collect clinical samples.

You may not qualify if:

• Malignant disease in the past five years;
• Participant with no hope of survival were clinically predicted and only received hospice care, or those who were in a deep coma and did not respond to supportive treatment measures within three hours of admission.
• Participant who are participating in other clinical trials or who have participated in other clinical trials within 3 months.
• Cases of severe shock and respiratory failure.

Sponsors & Collaborators

• Puren Hospital Affiliated to Wuhan University of Science and Technology: lead
• Shanghai University: collaborator
• Qingdao Co-orient Watson Biotechnology group co. LTD: collaborator
• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: collaborator

Study Sites (1)

Puren Hospital Affiliated to Wuhan University of Science and Technology

Wuhan, Hubei, 430081, China

RECRUITING

MeSH Terms

Conditions

COVID-19; Critical Illness

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yan Liu, MD

CONTACT

+8613387517458; 447822853@qq.com

Yue Zhu

CONTACT

+8617786289703; 978925651@qq.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2020
• First Posted: April 9, 2020
• Study Start: February 1, 2020
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: April 9, 2020

Record last verified: 2020-04

Locations

CN (1)