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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02767817 |
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Date of registration:
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29/04/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Injectable Collagen Scaffold™ Combined With MSCs Transplantation for Brain Injury
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Scientific 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 |
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Date of first enrolment:
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March 2016 |
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Target sample size:
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30 |
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Recruitment status: |
Unknown status |
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URL:
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https://clinicaltrials.gov/show/NCT02767817 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
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Phase:
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Phase 1
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Countries of recruitment
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China
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Contacts
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Name:
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Jianwu Dai, Ph.D |
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Address:
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Telephone:
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Email:
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Affiliation:
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Chinese Academy of Sciences |
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Key inclusion & exclusion criteria
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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.
Age minimum:
35 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Brain Injury
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Intervention(s)
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Procedure: Stereotactic Hematoma Evacuation
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Biological: Injectable Collagen Scaffold with MSCs Transplantation
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Biological: MSCs Transplantation
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Primary Outcome(s)
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Number of adverse events and participants with those adverse events
[Time Frame: 24 month]
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Secondary Outcome(s)
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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]
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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]
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Change in motor recovery evaluated by Brunnstrom stage
[Time Frame: 1, 3, 6, 12, 18 and 24 month after surgery]
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Change in pain intensity as measured by Visual Analogue Scale (VAS)
[Time Frame: 1, 3, 6, 12, 18 and 24 month after surgery]
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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]
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Change in self-care ability as measured by Barthel Index (BI)
[Time Frame: 1, 3, 6, 12, 18 and 24 month after surgery]
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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]
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Secondary ID(s)
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CAS-XDA-BI/IGDB
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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