Safety and efficacy evaluation of human Mesenchymal Stem Cells (MSCs) in patients with SARS-CoV-2 infectio

Phase 1

• Conditions: Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

• Registration Number: CTRI/2021/09/036645
• Lead Sponsor: ifeCell International Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1 A positive reverse transcription, polymerase chain reaction (RT-PCR) assay for SARS-CoV-2.

2 Patients currently hospitalized with moderate to severe SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus) infection (COVID19) satisfying the criteria as below:

a. Peripheral capillary oxygen saturation (SpO2) �94%.

b. Respiratory rate �24 breaths per minute with/without breathlessness.

3 Lower respiratory tract infection at screening suggestive of moderate to severe COVID19 disease: radiographic infiltrates on X-ray chest (PA view) or chest spiral CT scan.

4 Patients with onset of COVID19 symptoms within 5 days prior to screening.

5 Willing and able to provide written informed consent prior to performing any study related procedure.

Exclusion Criteria

1 Patients with mild COVID19 disease (SpO2 >94%, and/or respiratory rate <24 breaths per minute.

2 High risk individuals:

a Age > 60 years

b Known patients of any cardiovascular disease, hypertension, and CAD

c Known patients of type-1 or type-2 diabetes mellitus

d Any immunocompromised states

e History of chronic lung/kidney/liver disease

f History of any cerebrovascular disease

g Obesity

3 Participation in any other clinical trial of an experimental treatment for COVID-19.

4 Evidence of multiorgan failure.

5 Mechanically ventilated (including V-V ECMO or V-A ECMO).

6 Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) >5 times upper limit of normal (ULN).

7 Creatinine clearance <30 mL/min using the Cockcroft-Gault formula.

8 Pregnant or breast-feeding women.

9 Anticipated discharge from the hospital or transfer to another hospital within 72 hours of enrolment.

10 Hypersensitivity to active ingredient(s) or any of the excipients of the study formulation.

11 Patient who declines to sign the written informed consent.

12 Patients with any other clinical conditions which, in the opinion of the investigator, would not allow for the safe completion of the protocol.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Proportion of participants experiencing Treatment-Emergent Adverse Events (TEAE). <br/ ><br>2. 28-day mortality <br/ ><br>Timepoint: 1. Proportion of participants experiencing Treatment-Emergent Adverse Events (TEAE) during 28 days of study. <br/ ><br>2. Percent mortality 28 days after drug administration <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
1.Proportion of patients with clinical recovery (clinical recovery defined as the first day on which the subject has improvement in 2 points from baseline recorded on the 8-category ordinal scale for clinical improvement) from day 1 through day 28. <br/ ><br>2.Time to recovery (defined as the first day on which the subject satisfies criteria�s 1, 2 or 3 of the 8-category ordinal scale for clinical improvement). <br/ ><br>3.Total duration of hospital stays (days). <br/ ><br>4. Proportion of patients who achieve a peripheral capillary oxygen saturation (SpO2) �94% on room air after start of therapy <br/ ><br>Timepoint: 28 days Follow up