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| Name | Class |
|---|---|
| HeartStem Institute | UNKNOWN |
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This double blind, placebo controlled, multi-arm, multi-site study investigates the safety and efficacy of stem cell therapy for the treatment of patients admitted to hospital suffering complications from COVID-19 and the treatment of healthy subjects (healthcare providers) for prophylactic effect following those patients.
Recent preliminary data from Wuhan/China have claimed that intravenous injections of mesenchymal stem cells derived from human umbilical chords have resulted in complete recovery of COVID-19 infected elderly patients with respiratory failure.
This study investigates the efficacy and safety of a single umbilical cord derived stem cell intravenous injection in patients with suspected or confirmed COVID-19 infection with fever and respiratory illness.
A second arm will test efficacy and safety of a single umbilical cord derived stem cell intravenous injection to healthcare providers at high exposure rates to COVID-19 infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COVID-19 Patients Experimental | Experimental | 13 COVID-19 infected subjects (Patients admitted to hospital suffering complications from COVID-19) will be randomized and equally distributed between placebo and experimental intervention. |
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| COVID-19 Patients Placebo | Placebo Comparator | 13 COVID-19 infected subjects (Patients admitted to hospital suffering complications from COVID-19) will be randomized and equally distributed between placebo and experimental intervention. |
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| Healthcare Providers Experimental | Experimental | 7 healthy subjects (healthcare providers following patients admitted to hospital suffering complications from COVID-19) will be randomized and equally distributed between placebo and experimental intervention. |
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| Healthcare Providers Placebo | Placebo Comparator | 7 healthy subjects (healthcare providers following patients admitted to hospital suffering complications from COVID-19) will be randomized and equally distributed between placebo and experimental intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PrimePro | Biological | Intravenous Injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Survival Rates | Survival Rate in COVID-19 infected patients admitted to hospital for complications | 30 Days |
| Contraction Rates | Contraction Rate of COVID-19 in healthy healthcare workers following patients admitted to hospital for complications due to COVID-19 | 30 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ernst R Von Schwarz, MD, PhD | HeartStem Institute, Southern California Hospital at Culver City | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern California Hospital at Culver City / Southern California Hospital at Hollywood | Culver City | California | 92032 | United States |
Data will be blinded and password protected. Research publications will be produced for medical journals. Participating Investigators will have password protected access only.
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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This study is a randomized assignment, double-blind, placebo-controlled, multi-arm, multi-site study located at Southern California Hospitals at Culver City and Hollywood.
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| Placebo | Other | Intravenous Injection |
|
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |