Back to resultsInjectable Collagen Scaffold™ Combined With MSCs Transplantation for Brain Injury
Primary Purpose
Brain Injury
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Stereotactic Hematoma Evacuation
MSCs Transplantation
Injectable Collagen Scaffold with MSCs Transplantation
Sponsored by
About this trial
This is an interventional treatment trial for Brain Injury
Eligibility Criteria
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.
Sites / Locations
- Affiliated Hospital of Logistics Universtiy of CAPF
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Sham Comparator
Experimental
Experimental
Arm Label
Stereotactic Hematoma Evacuation
MSCs Transplantation
Injectable Collagen Scaffold with MSCs Transplantation
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in functional outcomes as measured by National Institutes of Health stroke scale (NIHSS) score
Change in motor recovery evaluated by Brunnstrom stage
Change in self-care ability as measured by Barthel Index (BI)
Change in pain intensity as measured by Visual Analogue Scale (VAS)
Change in electrical brain activity as measured by Electroencephalography (EEG)
Changes in brain electrophysiology as measured by Somatosensory evoked potential (SSEP)
Change in brain pathology diagnosed by Head CT scan
Full Information
NCT ID
NCT02767817
First Posted
April 29, 2016
Last Updated
December 21, 2020
Sponsor
Chinese Academy of Sciences
Collaborators
Affiliated Hospital of Logistics University of CAPF
1. Study Identification
Unique Protocol Identification Number
NCT02767817
Brief Title
Injectable Collagen Scaffold™ Combined With MSCs Transplantation for Brain Injury
Official Title
The Safety and Efficacy Assessment of Injectable Collagen Scaffold™ Combined With Mesenchymal Stem Cells Transplantation in Patients With Brain Injury
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Sciences
Collaborators
Affiliated Hospital of Logistics University of CAPF
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Stereotactic Hematoma Evacuation
Arm Type
Sham Comparator
Arm Title
MSCs Transplantation
Arm Type
Experimental
Arm Title
Injectable Collagen Scaffold with MSCs Transplantation
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Stereotactic Hematoma Evacuation
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
MSCs Transplantation
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Injectable Collagen Scaffold with MSCs Transplantation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of adverse events and participants with those adverse events
Description
Proportion of patients with postoperative infections and serious adverse events (SAEs) will be assessed by long term follow-up.
Time Frame
24 month
Secondary Outcome Measure Information:
Title
Change in functional outcomes as measured by National Institutes of Health stroke scale (NIHSS) score
Time Frame
baseline, day 1-7, and 1, 3, 6, 12, 18 and 24 month after surgery
Title
Change in motor recovery evaluated by Brunnstrom stage
Time Frame
1, 3, 6, 12, 18 and 24 month after surgery
Title
Change in self-care ability as measured by Barthel Index (BI)
Time Frame
1, 3, 6, 12, 18 and 24 month after surgery
Title
Change in pain intensity as measured by Visual Analogue Scale (VAS)
Time Frame
1, 3, 6, 12, 18 and 24 month after surgery
Title
Change in electrical brain activity as measured by Electroencephalography (EEG)
Time Frame
baseline, day 1, 4, 7, and 1, 3, 6, 12, 18, 24 month after surgery
Title
Changes in brain electrophysiology as measured by Somatosensory evoked potential (SSEP)
Time Frame
baseline, day 1,4,7, and 1, 3, 6, 12, 18, 24 month after surgery
Title
Change in brain pathology diagnosed by Head CT scan
Time Frame
baseline, day 1,4,7, and 1, 3, 6, 12, 18, 24 month after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianwu Dai, Ph.D
Organizational Affiliation
Chinese Academy of Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Affiliated Hospital of Logistics Universtiy of CAPF
City
Tianjin
ZIP/Postal Code
300162
Country
China
12. IPD Sharing Statement
Learn more about this trial
Injectable Collagen Scaffold™ Combined With MSCs Transplantation for Brain Injury
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