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| ID | Type | Description | Link |
|---|---|---|---|
| hDPSC-CoVID-2019-02-2020 | Other Identifier | Renmin Hospital of Wuhan University |
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| Name | Class |
|---|---|
| Beijing SH Bio-Tech Corporation, Beijing (CN) | UNKNOWN |
| Utooth Biological Technology Co., Ltd. Hubei (CN) | UNKNOWN |
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This clinical trial is set out to evaluate the safety and efficacy of allogeneic human dental pulp mesenchymal stem cells in the treatment of severe pneumonia caused by COVID-19; to explore the effects of human dental pulp mesenchymal stem cells in the treatment of severe pneumonia of COVID-19 in terms of reducing mortality and improving clinical prognosis; and to discover a new therapeutic strategy for COVID-19 using allogeneic human dental pulp mesenchymal stem cells.
This clinical trial is set out to evaluate the followings:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hDPSCs group | Experimental | Routine treatment + Intravenous injection of human dental pulp stem cells |
|
| Control group | Placebo Comparator | Routine treatment + Intravenous saline injection (Placebo) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| allogeneic human dental pulp stem cells (BSH BTC & Utooth BTC) | Biological | Intravenous injection of 3.0x10e7 human dental pulp stem cells solution (30ml) on day 1, day 4 and day 7, based on routine treatment of COVID-19 |
| Measure | Description | Time Frame |
|---|---|---|
| TTCI | Time to Clinical Improvement | 1-28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Lung lesion | Lung Lesion by CT | 1-28 days |
| Immune function |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qingsong Ye, PhD,DDS | Contact | +8615858242516 | qingsongye@foxmail.com | |
| Chenliang Zhou, PhD | Contact | +862788041919 | 83920 |
| Name | Affiliation | Role |
|---|---|---|
| Prof. Qingsong Ye, PhD,DDS | Center for Regenerative Medicine, Renmin Hospital of Wuhan University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renmin Hospital of Wuhan University (East Campus) | Recruiting | Wuhan | Hubei | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32532356 | Derived | Ye Q, Wang H, Xia X, Zhou C, Liu Z, Xia ZE, Zhang Z, Zhao Y, Yehenala J, Wang S, Zhou G, Hu K, Wu B, Wu CT, Wang S, He Y. Safety and efficacy assessment of allogeneic human dental pulp stem cells to treat patients with severe COVID-19: structured summary of a study protocol for a randomized controlled trial (Phase I / II). Trials. 2020 Jun 12;21(1):520. doi: 10.1186/s13063-020-04380-5. |
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| Intravenous saline injection (Placebo) | Other | Intravenous injection of 3ml of 0.9% saline on day 1, day 4 and day 7, based on routine treatment of COVID-19 |
|
| 1-28 days |
| Time of SARS-CoV-2 clearance | Time of SARS-CoV-2 test turns negative | 1-28 days |
| Blood test | Blood cell count and classification | 1-28 days |
| SPO2 | Pulse oximetry | 1-28 days |
| RR | Respiratory rate | 1-28 days |
| Body temperature | Body temperature | 1-28 days |
| Side effects in the treatment group | Number of the included patients with hDPSCs-related adverse events, e.g. liver or kidney function failure | 1-28 days |
| C-reactive protein (mg/L) | C-reactive protein in microgram per litre | 1-28 days |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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