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This is an interventional new drug clinical trial for a Phase 2 randomized, double-blind, and placebo control study using intravenous injection of allogeneic adipose stem cells (Celltex AdMSCs) for subjects with severe COVID-19.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group | Experimental | Each subject receives three separate doses of 200 million allogeneic adipose-derived mesenchymal stem cells via intravenously infusion on days 0, 3, and 6 with a total of 600 million AdMSCs during 7 days in addition to their standard of care. |
|
| Control Group | Placebo Comparator | The control group will receive placebo infusion on day 0, 3 and 6 along with standard of care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allogeneic adipose-derived stem cells | Biological | Culture expanded mesenchymal stem cells isolated from a patient's own abdominal fat tissue |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of AdMSC injection will be evaluated by assessment of the frequency and nature of adverse events occurring during the study based on the rate of all AdMSC-associated adverse events (AEs) in all subjects. | Incidence of treatment-related adverse events and severe adverse events during the study period | 6 months |
| Safety for AdMSCs based upon incidence of all AEs | Grouped by Medical Dictionary for Regulatory Activities (MedDRA) | 6 months |
| Compare the mortality rate | AdMSC treating group vs. control group | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Recognized immune measurements evaluating patients' symptom changes and overall function | To evaluate change of sequential organ failure assessment (SOFA) score as compare to the baseline | 6 months |
| Organ functional tests including blood specific enzymes and proteins |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality rate down to 0% | For severe and critical cases | 6 months |
| Achieve at least 30% more proportion of severe patients in AdMSC study group without developing organ failure or recovery from previous organ failure |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jane Young, Ph.D. | Contact | 7135901000 | jyoung@celltexbank.com |
| Name | Affiliation | Role |
|---|---|---|
| Derek W Guillory, MD | Root Causes Medicine | Principal Investigator |
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| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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The Phase 2 study is a randomized, double blind and placebo control study conducted initially in a single clinic facility.
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To evaluate the efficacy of allogeneic AdMSCs for COVID-19 |
| 6 months |
| Duration (days) of weaning from mechanical ventilation | Compared to control group | 6 months |
| Duration (days) of ICU monitoring | Compared to control group | 6 months |
| Duration (days) of vasoactive agent's usage | Compared to control group | 6 months |
| Duration of hospitalization (days) | Compared to control group | 6 months |
| Proportions of SARS-CoV-2 RT-PCR change to negative from respiratory tract specimens (oropharyngeal swabs) using CDC standard method | Compared to control group | 6 months |
| Proportions of quantifying viral RNA in stool change to negative in final follow-up using CDC standard method | Compared to control group | 6 months |
| Proportions of blood SARS-CoV-2 antibodies IgM/IgG show positive | Compared to control group | 6 months |
Compared to control group
| 6 months |
| D007239 |
| Infections |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |