Efficacy of Intravenous Infusions of Stem Cells in the Treatment of COVID-19 Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04437823|
Recruitment Status : Recruiting
First Posted : June 18, 2020
Last Update Posted : June 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Corona Virus Infection||Biological: Intravenous Infusions of Stem Cells||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
Group 1 (15 subjects) Fifteen (15) subjects will be treated with three intravenous infusion (IV) of 5 x 10^5 (per Kg body weight) UCMSCs delivered via peripheral intravenous infusion on days 1, 3 and 5 besides the standard care (SOC).
Group 2 (5 subjects) Five (5) subjects will be treated under SOC. From two subjects in group 1 will not be treated 24hrs apart. Patients will be randomized in a 1:3 ratio (SOC: UCMSC).
|Masking:||None (Open Label)|
|Official Title:||Efficacy of Intravenous Infusions of Stem Cells in the Treatment of COVID-19 Patients|
|Actual Study Start Date :||June 1, 2020|
|Estimated Primary Completion Date :||May 31, 2021|
|Estimated Study Completion Date :||June 30, 2021|
Experimental: Group 1 : Treatment
Fifteen (15) subjects will be treated with three intravenous infusion (IV) of 5 x 10^5 UCMSCs per Kg body weight delivered via peripheral intravenous infusion on days 1, 3 and 5 besides the standard care (SOC).
Biological: Intravenous Infusions of Stem Cells
Cultured stem cells will be injected at days 1, 3 and 5 intravenously. While patients will be monitored and evaluated for various hematological and organ functions at baseline (day 0) and days 1, 3, 5, 7, 14, 21 and 30
No Intervention: Group 2: standard care
Five (5) subjects will be treated under Standard of Care (SOC) .
- Safety and efficacy assessment of infusion associated adverse events [ Time Frame: Day 01 to Day 30 ]Number of participants with significant side effects in stem cell treated group
- Chest Radiograph or Chest CT Scan [ Time Frame: Day 01 to Day 30 ]Assessment of Pneumonia improvement as a result of stem cell infusions
- COVID-19 Quantitative Real Time PCR [ Time Frame: Day 01 to Day 30 ]Quantitative real-time PCR analysis for the evaluation of negative corona virus test results following stem cell treatment
- Sequential Organ Failure Assessment (SOFA) Score [ Time Frame: Day 01 to Day 30 ]Evaluation of organ function (Each organ system is assigned a value for 0 (normal) to 4 (highest degree of dysfunction))
- Rate of mortality [ Time Frame: Day 01 to Day 30 ]Number of all mortalities within 30 days post first infusion
- Clinical Respiratory Changes [ Time Frame: Day 01 to Day 30 ]Examination of improvement in the physiology of lungs after treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04437823
|Contact: Sheikh Riazuddin, PhDfirstname.lastname@example.org|
|Contact: Mohsin Shahzad, PhDemail@example.com|
|Lahore, Punjab, Pakistan, 54550|
|Principal Investigator:||Moazzam N Tarar, MBBS, FCPS||Jinnah Burn & Reconstructive Surgery Center, Lahore|
|Principal Investigator:||Azra Mehmood, PhD||Centre of Excellence in Molecular Biology, Lahore|