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Injectable Collagen Scaffold™ Combined With MSCs Transplantation for Brain Injury

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ClinicalTrials.gov Identifier: NCT02767817
Recruitment Status : Recruiting
First Posted : May 10, 2016
Last Update Posted : May 10, 2016
Sponsor:
Collaborator:
Affiliated Hospital of Logistics University of CAPF
Information provided by (Responsible Party):
Jianwu Dai, 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.

Condition or disease Intervention/treatment Phase
Brain Injury Procedure: Stereotactic Hematoma Evacuation Biological: MSCs Transplantation Biological: Injectable Collagen Scaffold with MSCs Transplantation Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Safety and Efficacy Assessment of Injectable Collagen Scaffold™ Combined With Mesenchymal Stem Cells Transplantation in Patients With Brain Injury
Study Start Date : March 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Collagen

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.




Primary Outcome Measures :
  1. Number of adverse events and participants with those adverse events [ Time Frame: 24 month ]
    Proportion of patients with postoperative infections and serious adverse events (SAEs) will be assessed by long term follow-up.


Secondary Outcome Measures :
  1. 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 ]
  2. Change in motor recovery evaluated by Brunnstrom stage [ Time Frame: 1, 3, 6, 12, 18 and 24 month after surgery ]
  3. Change in self-care ability as measured by Barthel Index (BI) [ Time Frame: 1, 3, 6, 12, 18 and 24 month after surgery ]
  4. Change in pain intensity as measured by Visual Analogue Scale (VAS) [ Time Frame: 1, 3, 6, 12, 18 and 24 month after surgery ]
  5. 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 ]
  6. 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 ]
  7. 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 ]


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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02767817


Contacts
Contact: Zhifeng Xiao, Ph.D 86-10-82614420 zfxiao@genetics.ac.cn
Contact: Sufang Han, Ph.D 86-10-82614420 sufanghan22@genetics.ac.cn

Locations
China
Affiliated Hospital of Logistics Universtiy of CAPF Recruiting
Tianjin, China, 300162
Contact: Yue Tu, M.D.         
Sponsors and Collaborators
Chinese Academy of Sciences
Affiliated Hospital of Logistics University of CAPF
Investigators
Principal Investigator: Jianwu Dai, Ph.D Chinese Academy of Sciences

Responsible Party: Jianwu Dai, Principal Investigator of Regenerative Medicine Laboratory, Institute of Genetics and Developmental Biology, CAS, Chinese Academy of Sciences
ClinicalTrials.gov Identifier: NCT02767817     History of Changes
Other Study ID Numbers: CAS-XDA-BI/IGDB
First Posted: May 10, 2016    Key Record Dates
Last Update Posted: May 10, 2016
Last Verified: April 2016

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System