Injectable Collagen Scaffold™ Combined With MSCs Transplantation for Brain Injury

Chinese Academy of Sciences30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Brain Injury

Interventions

Stereotactic Hematoma EvacuationPROCEDURE

MSCs TransplantationBIOLOGICAL

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 TransplantationBIOLOGICAL

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

Sex: ALLMin age: 35 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Affiliated Hospital of Logistics Universtiy of CAPF

Tianjin, China

Outcomes

Primary Outcomes

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.

Time frame: 24 month

Secondary Outcomes

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

Change in motor recovery evaluated by Brunnstrom stage

Time frame: 1, 3, 6, 12, 18 and 24 month after surgery

Change in self-care ability as measured by Barthel Index (BI)

Time frame: 1, 3, 6, 12, 18 and 24 month after surgery

Change in pain intensity as measured by Visual Analogue Scale (VAS)

Time frame: 1, 3, 6, 12, 18 and 24 month after surgery

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

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

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

Data from ClinicalTrials.gov

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