Mesenchymal Stem Cell Therapy For Covid 19

A Phase 1 clinical trial of intravenous administration of mesenchymal stem cells derived from umbilical cord and placenta in patients with novel COVID-19 virus pneumonia.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/08/027043

Enrollment

Registered

2020-08-09

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Mesenchymal Stem Cells: Mesenchymal Stem cells derived from umbilical cord and placenta Control Intervention1: Not Applicable: Not Applicable

Eligibility

Inclusion criteria

Inclusion criteria: Patients admitted with RT-PCR confirmed COVID-19 illness. Age: 18-65 years without any uncontrolled comorbidities like hypertension, diabetes, renal failure, etc Written informed consent Has any of the two PaO2/ FiO2: 200-300 Respiratory Rate > 24/min and SaO2 <= 93% on room air

Exclusion criteria

Exclusion criteria: Pregnant women Breastfeeding women Critically ill patients: P/F ratio Shock (Requiring Vasopressor to maintain a MAP >= 65mmHg or MAP below 65) Patients with other severe co-morbidities like cancer, chronic renal, chronic liver failure and chronic cardiac failure. This will not include diabetes, hypertension, etc Participating in any other clinical trial

Design outcomes

Primary

Measure	Time frame
1. Avoidance of - Progression to severe ARDS (P/F ratio 100) and All-cause Mortality at 28 days 2. Oxygenation Index : SpO2 3. Multi Organ Function: CBC,LFT,Serum Creatinine,Electrolytes, 4. Troponin and Myoglobin 5. Clinical measures: Fever and Respiratory Rate 6.Immediate Adverse Events occurring after IV administration of MSCs 7. Other adverse events e.g. Pulmonary embolism, Stroke, Arrhythmias, Liver failureTimepoint: All Days	—

Measure

Time frame

1. Avoidance of - Progression to severe ARDS (P/F ratio 100) and All-cause Mortality at 28 days 2. Oxygenation Index : SpO2 3. Multi Organ Function: CBC,LFT,Serum Creatinine,Electrolytes, 4. Troponin and Myoglobin 5. Clinical measures: Fever and Respiratory Rate 6.Immediate Adverse Events occurring after IV administration of MSCs 7. Other adverse events e.g. Pulmonary embolism, Stroke, Arrhythmias, Liver failureTimepoint: All Days

—

Secondary

Measure	Time frame
Time to recovery on 8 Point ordinal scale Time to symptom resolution (Fever, Cough, Shortness of Breath) Duration of Hospital stay after intervention Change in SOFA Duration of respiratory support required (Invasive mechanical ventilation and non invasive) Radiological improvement (Chest X Ray/ Chest CT scan) Duration of conversion of positive to negative Covid 19 from RT PCR Levels of CRP, IL6, TNF-alpha, Ferritin, CD3, CD4, CD4/CD8Timepoint: Lab parameters- Day 0, 2,4,6,8, 14 days Xray- 0,7,14,21,28 days and 6 months	—

Measure

Time frame

Time to recovery on 8 Point ordinal scale Time to symptom resolution (Fever, Cough, Shortness of Breath) Duration of Hospital stay after intervention Change in SOFA Duration of respiratory support required (Invasive mechanical ventilation and non invasive) Radiological improvement (Chest X Ray/ Chest CT scan) Duration of conversion of positive to negative Covid 19 from RT PCR Levels of CRP, IL6, TNF-alpha, Ferritin, CD3, CD4, CD4/CD8Timepoint: Lab parameters- Day 0, 2,4,6,8, 14 days Xray- 0,7,14,21,28 days and 6 months

—

Countries

India

Contacts

Public ContactDr Abhijit Bopardikar

ReeLabs Pvt. Ltd.

drrohitrkulkarni@gmail.com9820526618

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 17, 2026