Injectable Collagen Scaffold™ Combined With MSCs Transplantation for Brain Injury

Study Overview
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Brief Summary
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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.

Official Title
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The Safety and Efficacy Assessment of Injectable Collagen Scaffold™ Combined With Mesenchymal Stem Cells Transplantation in Patients With Brain Injury

Conditions
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Brain Injury

Intervention / Treatment
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* Procedure: Stereotactic Hematoma Evacuation
* Biological: MSCs Transplantation
* Biological: Injectable Collagen Scaffold with MSCs Transplantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female，35-75 years old. The surgery time should be > 6 hours after symptom onset. Glasgow coma score (GCS) was 9-15. CT diagnosis of intracerebral hemorrhage (25-40 ml), except for patients with signs of craniotomy to remove the hematoma. Signed informed consent obtained from the patient or patient's legally authorized representative. Exclusion Criteria: Glasgow coma scale of <8. Patients suffering severe heart failure, severe lung disease, uremia, cirrhosis, end-stage cancer, coagulation disorders, stroke sequela. Asphyxia, cardiac arrest or successful cardiopulmonary resuscitation before hospitalization. Lactating or pregnant woman. Refuse to sign informed content.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Stereotactic Hematoma Evacuation<br> | Procedure: Stereotactic Hematoma Evacuation<br>* 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.<br>|
| Experimental: MSCs Transplantation<br> | Biological: MSCs Transplantation<br>* 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.<br>|
| Experimental: Injectable Collagen Scaffold with MSCs Transplantation<br> | Biological: Injectable Collagen Scaffold with MSCs Transplantation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events and participants with those adverse events | Proportion of patients with postoperative infections and serious adverse events (SAEs) will be assessed by long term follow-up. | 24 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 electrical brain activity as measured by Electroencephalography (EEG) |  | baseline, day 1, 4, 7, and 1, 3, 6, 12, 18, 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 |