Injectable Collagen Scaffold™ Combined With MSCs Transplantation for Brain Injury

Phase 1

• Conditions: Brain Injury
• Interventions: Procedure: Stereotactic Hematoma Evacuation; Biological: Injectable Collagen Scaffold with MSCs Transplantation; Biological: MSCs Transplantation

• Registration Number: NCT02767817
• Lead Sponsor: Chinese Academy of Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03
• Status Verified: 2016-04
• Study First Submitted: 2016-04-29
• Study First Submitted QC: 2016-05-09
• Study First Posted: 2016-05-10
• Last Update Submitted: 2020-12-21
• Last Update Posted: 2020-12-23
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stereotactic Hematoma Evacuation	Stereotactic Hematoma Evacuation	-
Injectable Collagen Scaffold with MSCs Transplantation	Injectable Collagen Scaffold with MSCs Transplantation	-
MSCs Transplantation	MSCs Transplantation	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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 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 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 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

Trial Locations

Locations (1)

Affiliated Hospital of Logistics Universtiy of CAPF; 🇨🇳 Tianjin, China