Study of Intravenous Administration of Allogeneic Adipose Stem Cells for COVID-19 (CoronaStem1)
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|ClinicalTrials.gov Identifier: NCT04486001|
Recruitment Status : Not yet recruiting
First Posted : July 24, 2020
Last Update Posted : November 6, 2020
|Condition or disease||Intervention/treatment||Phase|
|Covid19||Biological: PSC-04||Phase 1|
This study is single arm, non-randomized Phase 1 study of the safety and preliminary efficacy of PSC-04, an adipose-derived allogeneic mesenchymal stem cell. The outcome data will be compared to contemporaneous non-enrolled patients at the same clinical site(s) as the enrolled patients.
Primary: To evaluate the safety of intravenous infusion of allogeneic adipose stem cells in patients with COVID-19 disease and respiratory distress.
Secondary: To evaluate a set of secondary safety and efficacy outcome variables to give guidance in assessing the risk/benefit ratio in patients with COVID-19 respiratory distress.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||single group comparison with cohort of contemporaneous non-treated patients.|
|Masking:||None (Open Label)|
|Official Title:||COVID-19 Stem Cell Therapy: A Phase I Study of Intravenous Administration of Allogeneic Adipose Stem Cells|
|Estimated Study Start Date :||December 15, 2020|
|Estimated Primary Completion Date :||January 15, 2021|
|Estimated Study Completion Date :||January 15, 2021|
Experimental: Treatment Group
This is single arm study with only comparison to non-treated cohorts at site.
adipose stem cells derived from screened donor lipoaspirate and culture expanded.
Other Name: allogeneic, adipose-derived stem cells
- Frequency of all adverse events [ Time Frame: Through study completion, an average of three months ]Frequency of all reported adverse events in study
- Frequency of infusion related serious adverse events [ Time Frame: 6 hours post infusion ]Frequency of SAEs in the 6 hours post-infusion for each infusion
- Frequency of serious adverse events [ Time Frame: Through study completion, an average of three months ]Frequency of all serious adverse events in study
- Mortality [ Time Frame: Study days 0-28 ]All-cause mortality through Day 28
- Ventilator Free Days [ Time Frame: Study days 0-28 ]Ventilator free days through Study day 28
- ICU Free Days [ Time Frame: Days 0 through 28 ]Total days not in ICU from Study day 0 through Study day 28
- Total Hospital Days [ Time Frame: Days 0 through discharge, an average of 28 days ]Total Days in Hospital from Day 0 through discharge for survivors
- Total ICU Days [ Time Frame: Days 0 through discharge, an average of 28 days ]Total Days in ICU from Day 0 through discharge for survivors
- Improvement in Oxygenation [ Time Frame: Study days 0, 2, 4, 6 ]Improvement in oxygenation comparing Study day 0, to days 2, 4, 6
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): NCT04486001
|Contact: Susan P Harman, BSemail@example.com|
|Contact: Robert J Harman, DVM, MPVMfirstname.lastname@example.org|
|Principal Investigator:||Christopher Rogers, MD||Personalized Stem Cells, Inc.|