Injectable Collagen Scaffold™ Combined With MSCs Transplantation for Brain Injury

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

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 Overview

• Status: Unknown
• Conditions: Brain Injury
• Intervention / Treatment: Procedure: Stereotactic Hematoma Evacuation; Biological: MSCs Transplantation; Biological: Injectable Collagen Scaffold with MSCs Transplantation

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Tianjin, China, 300162
    • Affiliated Hospital of Logistics Universtiy of CAPF

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Stereotactic Hematoma Evacuation	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.
Experimental: MSCs Transplantation	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.
Experimental: Injectable Collagen Scaffold with MSCs Transplantation	Biological: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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 self-care ability as measured by Barthel Index (BI)	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 electrical brain activity as measured by Electroencephalography (EEG)	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)	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

Collaborators and Investigators

• Sponsor: Chinese Academy of Sciences
• Collaborators: Affiliated Hospital of Logistics University of CAPF

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: April 29, 2016
• First Submitted That Met QC Criteria: May 9, 2016
• First Posted (Estimate): May 10, 2016

Study Record Updates

• Last Update Posted (Actual): December 23, 2020
• Last Update Submitted That Met QC Criteria: December 21, 2020
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries
• Other Study ID Numbers: CAS-XDA-BI/IGDB