NCT02767817
Unknown
Phase 1
The Safety and Efficacy Assessment of Injectable Collagen Scaffold™ Combined With Mesenchymal Stem Cells Transplantation in Patients With Brain Injury
ConditionsBrain Injury
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Brain Injury
- Sponsor
- Chinese Academy of Sciences
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Number of adverse events and participants with those adverse events
- Last Updated
- 5 years ago
Overview
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.
Investigators
Jianwu Dai
Principal Investigator of Regenerative Medicine Laboratory, Institute of Genetics and Developmental Biology, CAS
Chinese Academy of Sciences
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-
- •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 \<
- •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.
Outcomes
Primary Outcomes
Number of adverse events and participants with those adverse events
Time Frame: 24 month
Proportion of patients with postoperative infections and serious adverse events (SAEs) will be assessed by long term follow-up.
Secondary Outcomes
- 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 electrical brain activity as measured by Electroencephalography (EEG)(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 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 pain intensity as measured by Visual Analogue Scale (VAS)(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)
Study Sites (1)
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