Mesenchymal Stem Cell Treatment for Pneumonia Patients Infected With COVID-19

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT04252118
• Date of registration: 27/01/2020
• Prospective Registration: Yes
• Primary sponsor: Beijing 302 Hospital
• Public title: Mesenchymal Stem Cell Treatment for Pneumonia Patients Infected With COVID-19
• Scientific title: Safety and Efficiency of Mesenchymal Stem Cell in Treating Pneumonia Patients Infected With COVID-19
• Date of first enrolment: January 27, 2020
• Target sample size: 20
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT04252118
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

China

Contacts

• Name: Lei Shi, MD,PhD

• Name: Lei Shi, MD, PhD

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Male or female, aged at 18 years (including) -70 years old

2. Confirmed COVID-19 by reverse-transcription polymerase chain reaction (RT-PCR) from
any diagnostic sampling source; and

3. Pneumonia that is judged by chest radiograph or computed tomography.

Exclusion Criteria:

1. Pregnancy, lactation and those who are not pregnant but do not take effective
contraceptives measures;

2. Patients with malignant tumor, other serious systemic diseases and psychosis;

3. Patients who are participating in other clinical trials;

4. Inability to provide informed consent or to comply with test requirements.

5. Co-Infection of HIV, tuberculosis, influenza virus, adenovirus and other respiratory
infection virus.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

COVID-19

Intervention(s)

Biological: MSCs

Primary Outcome(s)

Size of lesion area by chest radiograph or CT [Time Frame: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21,Day 28]

Side effects in the MSCs treatment group [Time Frame: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21, Day 28, Day 90 and Day 180]

Secondary Outcome(s)

Time of nucleic acid turning negative [Time Frame: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21, Day 28, Day 90 and Day 180]

Improvement of Clinical symptoms including duration of fever and respiratory [Time Frame: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21, Day 28]

C-reactive protein [Time Frame: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21, Day 28, Day 90 and Day 180]

CD4+ and CD8+ T celll count [Time Frame: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21, Day 28, Day 90 and Day 180]

Alanine aminotransferase [Time Frame: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21, Day 28, Day 90 and Day 180]

Creatine kinase [Time Frame: At Baseline , Day 3, Day 6, Day 10, Day 14, Day 21, Day 28, Day 90 and Day 180]

Rate of mortality within 28-days [Time Frame: Day 28]

Secondary ID(s)

2020003D

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Huoshenshan Hospital

Fifth Affiliated Hospital, Sun Yat-Sen University

Tianjin Haihe Hospital

Innovative Precision Medicine Group (IPM), Hangzhou, China.

Shenzhen Third People's Hospital

VCANBIO CELL & GENE ENGINEERING CORP.,LTD, China