Mesenchymal Stem Cell Infusion for COVID-19 Infection

• Status: Recruiting
• Trial end date: 2020-09-30
• Target enrollment: 0
• Participant gender: All

Summary

Since the outbreak of coronavirusdisease2019(COVID-19), many researchers in China have carried out/published clinical trials on treatment based on Western medicine, traditional Chinese medicine or a combination of the two. Trials on treatment modalities have mainly used antivirals, interferon, glucocorticoids in addition to traditional Chinese medicine. There are also clinical trials exploring hydroxyquinoline/chloroquine sulphate, immunoglobulins, Vitamin-C, washed microbiota, nebulized interferon, teicoplanin as well as Mesenchymal stem cells. However, most of these trials were small (median sample size 100) and the bulk of potential therapeutic strategies remain in the experimental phase and currently there is no effective specific antiviral with high-level evidence.The aim of this study is assess the efficacy of MSCs as an add-on therapy to standard supportive treatment for patients with moderate/severe COVID-19.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Armed Forces Bone Marrow Transplant Center, Rawalpindi, Pakistan; Dr. Zaineb Akram
• Collaborator: Pak Emirates Military Hospital

Criteria

Inclusion Criteria:

1. Male or female, aged ≥ 10years

2. Laboratory confirmation of COVID19 infection by reverse-transcription polymerase chain reaction (RT-PCR) from any diagnostic sampling source; and

3. Moderate illness: In compliance with the 2019-coronavirus 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 world health organization (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);

4. Critically ill : Respiratory failure, Septic Shock, muti-organ dysfunction syndrome (MODS)

Exclusion Criteria:

1. Patients with systemic autoimmune diseases

2. Not consenting for clinical trial

3. Those declared not for resuscitation due to underlying comorbid or current critical condition