Overview
The regulation of T cells / IL-17 pathway mediated by the intestinal flora has become a new molecular target for the treatment of SAP. To test whether TFXSCs are through the pathway as above, this protocol describes an ongoing randomized controlled clinical trial, based on the theory of traditional Chinese medicineTCM.
Description
This is a multicenter, randomized, double-blind, placebo-controlled clinical trial. A total of 378 patients will be recruited and randomly assigned to TFXSCs group or placebo-matched group in a 1:1 ratio. The treatment course is 10-12 consecutive days, with a 907-day follow-up.
Eligibility
Inclusion Criteria:
- Diagnosis of spontaneous haemorrhage according to Western medicine, CT scan of brain confirmed acute intracerebral hemorrhage;
- Aged between 18 and 85;
- Diagnosis of modified CDC;
- within 7 days after stroke onset;
- Willingness to participate and to sign the informed consent form.
Exclusion Criteria:
- Cerebral hemorrhage is confirmed by examination to be caused by a brain tumor, brain trauma, blood disease, cerebrovascular malformation (a congenital abnormality) or aneurysm;
- Patients with a cerebral hernia;
- GCS7;
- Received any antibiotic treatment within 4 weeks before the start of the study;
- Patients with pulmonary tuberculosis, pulmonary edema, pulmonary embolism, non-infectious pulmonary itomy and respiratory circulation failure;
- Patients with liver or kidney function (such as alanine aminotransferase [ALT], aspartate aminotransferase [AST] and creatinine[Cre]) 3 times higher than the normal upper limit;
- Patients with a clear history of gastrointestinal diseases such as gastrointestinal tumors, inflammatory bowel disease, a gastrointestinal bleeding period within 3 months;
- Patients with immune-related diseases such as SLE, rheumatoid arthritis, sjogren's syndrome or receiving immunotherapy for other diseases;
- Patients who are not suitable for the trial as decided by the researchers.