Injectable Collagen Scaffold™ Combined With MSCs Transplantation for Brain Injury

NCT02767817 | Unknown Phase 1 DMC

• 1 other identifier: CAS-XDA-BI/IGDB
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

Study Arms (3)

Stereotactic Hematoma Evacuation

SHAM COMPARATOR

Procedure: Stereotactic Hematoma Evacuation

MSCs Transplantation

EXPERIMENTAL

Biological: MSCs Transplantation

Injectable Collagen Scaffold with MSCs Transplantation

EXPERIMENTAL

Biological: Injectable Collagen Scaffold with MSCs Transplantation

Interventions

Stereotactic Hematoma Evacuation PROCEDURE

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.

Stereotactic Hematoma Evacuation

MSCs Transplantation BIOLOGICAL

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.

MSCs Transplantation

Injectable Collagen Scaffold with MSCs Transplantation BIOLOGICAL

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.

Injectable Collagen Scaffold with MSCs Transplantation

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female，35-75 years old.
• The surgery time should be \> 6 hours after symptom onset.
• Glasgow coma score (GCS) was 9-15.
• 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.

You may not qualify if:

• Glasgow coma scale of \<8.
• 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.

Sponsors & Collaborators

• Chinese Academy of Sciences: lead
• Affiliated Hospital of Logistics University of CAPF: collaborator

Study Sites (1)

Affiliated Hospital of Logistics Universtiy of CAPF

Tianjin, 300162, China

Location

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Jianwu Dai, Ph.D

  Chinese Academy of Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator of Regenerative Medicine Laboratory, Institute of Genetics and Developmental Biology, CAS

Study Record Dates

• First Submitted: April 29, 2016
• First Posted: May 10, 2016
• Study Start: March 1, 2016
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: December 23, 2020

Record last verified: 2016-04

Locations

CN (1)