Brain Injury
Conditions
Brief summary
The purpose of this study is to assess the safety and efficacy of injectable collagen scaffold combined with Mesenchymal stem cells (MSCs) transplantation in patients with brain injury.
Interventions
PROCEDUREStereotactic Hematoma Evacuation
Stereotactic intracranial hematoma and insert the drainage tube to inhale haematoma. The drainage tube stayed in the position for 1-2 days until adequate drainage of hematomas, and then the drainage tube was pulled out.
BIOLOGICALMSCs Transplantation
Stereotactic intracranial hematoma and insert the drainage tube to inhale haematoma. The drainage tube stayed in the position for 1-2 days until adequate drainage of hematomas,and 10 million MSCs were transplanted into the hematoma cavity before the drainage tube was pulled out.
BIOLOGICALInjectable Collagen Scaffold with MSCs Transplantation
Stereotactic intracranial hematoma and insert the drainage tube to inhale haematoma. The drainage tube stayed in the position for 1-2 days until adequate drainage of hematomas, and injectable collagen scaffold combined with 10 million MSCs were transplanted into the hematoma cavity before the drainage tube was pulled out.
Sponsors
Affiliated Hospital of Logistics University of CAPF
Chinese Academy of Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female，35-75 years old. 2. The surgery time should be \> 6 hours after symptom onset. 3. Glasgow coma score (GCS) was 9-15. 4. CT diagnosis of intracerebral hemorrhage (25-40 ml), except for patients with signs of craniotomy to remove the hematoma. 5. Signed informed consent obtained from the patient or patient's legally authorized representative.
Exclusion criteria
1. Glasgow coma scale of \<8. 2. Patients suffering severe heart failure, severe lung disease, uremia, cirrhosis, end-stage cancer, coagulation disorders, stroke sequela. 3. Asphyxia, cardiac arrest or successful cardiopulmonary resuscitation before hospitalization. 4. Lactating or pregnant woman. 5. Refuse to sign informed content.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of adverse events and participants with those adverse events | 24 month | Proportion of patients with postoperative infections and serious adverse events (SAEs) will be assessed by long term follow-up. |
Secondary
| Measure | Time frame |
|---|---|
| Change in motor recovery evaluated by Brunnstrom stage | 1, 3, 6, 12, 18 and 24 month after surgery |
| Change in self-care ability as measured by Barthel Index (BI) | 1, 3, 6, 12, 18 and 24 month after surgery |
| Change in pain intensity as measured by Visual Analogue Scale (VAS) | 1, 3, 6, 12, 18 and 24 month after surgery |
| Change in functional outcomes as measured by National Institutes of Health stroke scale (NIHSS) score | baseline, day 1-7, and 1, 3, 6, 12, 18 and 24 month after surgery |
| Changes in brain electrophysiology as measured by Somatosensory evoked potential (SSEP) | baseline, day 1,4,7, and 1, 3, 6, 12, 18, 24 month after surgery |
| Change in brain pathology diagnosed by Head CT scan | baseline, day 1,4,7, and 1, 3, 6, 12, 18, 24 month after surgery |
| Change in electrical brain activity as measured by Electroencephalography (EEG) | baseline, day 1, 4, 7, and 1, 3, 6, 12, 18, 24 month after surgery |
Countries
China
Outcome results
None listed