Deep Second-degree Burn
Conditions
Interventions
low-dose group:Umbilical cord mesenchymal stem cell injection 1.0×10^6/kg
middle-dose group:Umbilical cord mesenchymal stem cell injection 2.0×10^6/kg
high-dose group:Umbilical cord mesenchymal stem cell injection 5.0×10^6/kg
Sponsors
Shanghai Changhai Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 60 years, male or female; 2. Confirmed diagnosis of deep second-degree burn (excluding electrical or chemical burns),with TBSA between 30-50%.Injury within the prior 48 hours; 3. Subjects must understand and volunteer to give written informed consent.
Exclusion criteria
Exclusion criteria: 1. Those who are suspected or confirmed to be allergic to any component of the stem cell preparation under study, and those with allergies; 2. Patients with shock, severe infection, sepsis, moderate-to-severe inhalation injury, multiple injuries and compound injuries; 3. Complicated with other serious infectious diseases, diabetes, chronic malnutrition, autoimmune diseases (such as lupus erythematosus, multiple sclerosis, etc.) and severely poorly controlled hypertension, who have had myocardial infarction and cerebrovascular accident within 6 months By; 4. Those who have any serious diseases of major organs, such as the heart, lung, liver, kidney, blood system and nervous system and other basic diseases or serious complications, are judged by the investigator not to participate in the experiment; 5. Patients with malignant tumors; 6. Those who are currently receiving other treatments that may affect the safety/efficacy of stem cells; 7. Those who have used human epidermal growth factor drugs as wound treatment drugs; 8. Those who are positive for hepatitis B surface antigen, hepatitis C virus antibody, Treponema pallidum antibody, or human immunodeficiency virus antibody; 9. Women during pregnancy and breastfeeding; 10. Those who have participated in stem cell clinical trials, or those who have participated in other clinical trials within 3 months; 11. Other investigators judged that they are not suitable to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose limiting toxicity;Maximum tolerated dose; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pro-inflammatory factors;C reactive protein;Procalcitonin;Adverse events;Serious adverse event;Incidence of infusion-related adverse reactions;Incidence of burn wound infection;Healing time of burn wound;Healing results of burn wound at Day 28; | — |
Countries
China
Contacts
Public ContactZhu Feng
Shanghai Changhai Hospital
Outcome results
None listed