Injectable Collagen Scaffold™ Combined With MSCs Transplantation for Brain Injury

Brain Injury Clinical Trial

Official title:

The Safety and Efficacy Assessment of Injectable Collagen Scaffold™ Combined With Mesenchymal Stem Cells Transplantation in Patients With Brain Injury

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02767817
• Other study ID #: CAS-XDA-BI/IGDB
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: March 2016
• Est. completion date: December 2021

Study information

• Verified date: April 2016
• Source: Chinese Academy of Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injury
• Wounds and Injuries

Intervention

Procedure:
• Stereotactic Hematoma Evacuation
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.

Biological:
• MSCs Transplantation
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 Transplantation
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.

Locations

Country	Name	City	State
China	Affiliated Hospital of Logistics Universtiy of CAPF	Tianjin

Sponsors (2)

Lead Sponsor	Collaborator
Chinese Academy of Sciences	Affiliated Hospital of Logistics University of CAPF

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 month
Secondary	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
Secondary	Change in motor recovery evaluated by Brunnstrom stage		1, 3, 6, 12, 18 and 24 month after surgery
Secondary	Change in self-care ability as measured by Barthel Index (BI)		1, 3, 6, 12, 18 and 24 month after surgery
Secondary	Change in pain intensity as measured by Visual Analogue Scale (VAS)		1, 3, 6, 12, 18 and 24 month after surgery
Secondary	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
Secondary	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
Secondary	Change in brain pathology diagnosed by Head CT scan		baseline, day 1,4,7, and 1, 3, 6, 12, 18, 24 month after surgery