Injectable Collagen Scaffold™ Combined With MSCs Transplantation for Brain Injury
NCT ID: NCT02767817
Last Updated: 2020-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
30 participants
INTERVENTIONAL
2016-03-31
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Stereotactic Hematoma Evacuation
Stereotactic 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.
MSCs Transplantation
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 10 million MSCs were transplanted into the hematoma cavity before the drainage tube was pulled out.
Injectable Collagen Scaffold with MSCs Transplantation
Injectable 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.
Interventions
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Stereotactic 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.
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 10 million MSCs were transplanted into the hematoma cavity before the drainage tube was pulled out.
Injectable 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.
Eligibility Criteria
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Inclusion Criteria
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
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.
35 Years
75 Years
ALL
No
Sponsors
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Affiliated Hospital of Logistics University of CAPF
OTHER
Chinese Academy of Sciences
OTHER_GOV
Responsible Party
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Jianwu Dai
Principal Investigator of Regenerative Medicine Laboratory, Institute of Genetics and Developmental Biology, CAS
Principal Investigators
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Jianwu Dai, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Chinese Academy of Sciences
Locations
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Affiliated Hospital of Logistics Universtiy of CAPF
Tianjin, , China
Countries
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Other Identifiers
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CAS-XDA-BI/IGDB
Identifier Type: -
Identifier Source: org_study_id