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Umbilical Cord Derived Mesenchymal Stem Cells Treatment in Ischemic Stroke (Recruiting)

Primary Purpose

Stroke

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Human umbilical cord mesenchymal stem cells
Sponsored by
Affiliated Hospital to Academy of Military Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Cellular therapy, Stroke, Neuronal Plasticity, Recovery, umbilical cord mesenchymal stem cells, Transplantation, Cardiovascular Diseases, Ischemia, Brain Infarction, Brain Ischemia, Cerebrovascular Disorders

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Confirmed diagnosis of intracerebral ischemic stroke in three months by Magnetic Resonance Imaging(MRI)
  • Patients have received proper treatment within two weeks from the onset of stroke symptoms.
  • Age between 18 to 70 years old for men or women
  • Patients with persistent neurological deficit .
  • Obtaining informed consent signed (after being informed of the purpose, procedure, and venture of this study, the patient or guardian or legal representative must signing the informed consent document for engagement of participation.
  • Patients basic situation are allowable to be involved in the program.

Exclusion Criteria:

  • Patients with serious extensive stroke, who are unwilling to the risk.
  • Patients with serious persistent neurological deficit (NIHSS > 24).
  • Medical history of neurological pathology with a deficit as consequence (Rankin < 3 before stroke).
  • Patients with serious psychological disease.
  • Patients with myocardial infarction in recent 3 months.
  • Patients with recurring thromboembolic disease in recentin recent 3 months.
  • Patients with organ transplantation.
  • Patients with infection history including Human Immunodeficiency Virus(HIV),Human T-cell Leukemia Virus(HTLV), Hepatitis B Virus(HBV), Hepatitis C Virus(HCV),ect.
  • Patients receive current immunosuppressive/immunomodulating treatment.
  • Patients basic situation are unallowable to be involved in the program.
  • Patients who refuse to participate.
  • Patients who are inability or unwillingness of individual or legal guardian/representative to give written informed consent.
  • Patients who are pregnant or feeding women.
  • Patients who are Participating in another therapeutic clinical trial or in period of exclusion of a therapeutic clinical study.

Sites / Locations

  • Department of Neurosurgery,Affiliated Hospital of Academy of Military Medical Sciences(307 Hospital)

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

conventional stroke treatment

hUC-MSC treatment

Arm Description

Control group without intervention, whereas they receive conventional stroke treatment that including rehabilitation

Patients will receive human umbilical cord mesenchymal stem cells transplantation accompanied with conventional treatment including rehabilitation

Outcomes

Primary Outcome Measures

Number of treatment related-adverse events during the study period.

Secondary Outcome Measures

Comparison of National Institutes of Health stroke scale (NIHSS).
Comparison of modified Rankin scale (mRS).
Distinguish of EuroQol 5d (EQ-5D) between pre- and post-treatment 180 days.
Comparison of infarct size measured by brain MRI.

Full Information

First Posted
July 2, 2015
Last Updated
November 30, 2015
Sponsor
Affiliated Hospital to Academy of Military Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02580019
Brief Title
Umbilical Cord Derived Mesenchymal Stem Cells Treatment in Ischemic Stroke
Acronym
Recruiting
Official Title
Cell Therapy by Intravenous Injection of Umbilical Cord Derived Mesenchymal Stem Cells After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Affiliated Hospital to Academy of Military Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study aims at estimating the safety and efficacy of the intravenous injection of human umbilical cord mesenchymal stem cell(hUC-MSC) for patients suffering from ischemic stroke in recent 3 months.
Detailed Description
Given the attention paid in recent times, in China and elsewhere, to stroke, which is the leading cause of acquired adult disability and has negative effects on patients' quality of life.Therefore,It's little wonder there's much focus there days on treatment of stroke. For the patients who have suffered from ischemic stroke in 3 months, indeed, they have the opportunity to get symptomatic improvement through receiving conventional stroke treatments that including rehabilitation. At the same time, these treatments are ineffective in some cases. Alternatively, the phenomenon of increasing brain plasticity after stroke provoke an essential therapy. Human umbilical cord mesenchymal stem cells treatment enhances a functional improvement after cerebral ischemia, likewise, treament in rodent models are proved effective. Human umbilical cord mesenchymal stem cells therapy performs a role as take the place destroyed cerebral tissue with a stem cells graft. The totality of evidence from trials running umbilical cord mesenchymal stem cells transplanted into patients suffering from ischemic stroke support the safety of this approach. In terms of efficacy, positive results are reported in the majority of the trials. Our research project involves a development of cell therapy in a phase IIa clinical trial of safety and efficacy in patients (randomised, controlled, open, with 2 parallel groups).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Cellular therapy, Stroke, Neuronal Plasticity, Recovery, umbilical cord mesenchymal stem cells, Transplantation, Cardiovascular Diseases, Ischemia, Brain Infarction, Brain Ischemia, Cerebrovascular Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
conventional stroke treatment
Arm Type
No Intervention
Arm Description
Control group without intervention, whereas they receive conventional stroke treatment that including rehabilitation
Arm Title
hUC-MSC treatment
Arm Type
Experimental
Arm Description
Patients will receive human umbilical cord mesenchymal stem cells transplantation accompanied with conventional treatment including rehabilitation
Intervention Type
Biological
Intervention Name(s)
Human umbilical cord mesenchymal stem cells
Intervention Description
A single dose of 2×107 hUC-MSC will treated to patients, IV, Repeat every weeks for four times.
Primary Outcome Measure Information:
Title
Number of treatment related-adverse events during the study period.
Time Frame
180 days after transfusion
Secondary Outcome Measure Information:
Title
Comparison of National Institutes of Health stroke scale (NIHSS).
Time Frame
180 days after the cell treatment.
Title
Comparison of modified Rankin scale (mRS).
Time Frame
180 days after the cell treatment.
Title
Distinguish of EuroQol 5d (EQ-5D) between pre- and post-treatment 180 days.
Time Frame
180 days after the cell treatment.
Title
Comparison of infarct size measured by brain MRI.
Time Frame
180 days after the cell treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Confirmed diagnosis of intracerebral ischemic stroke in three months by Magnetic Resonance Imaging(MRI) Patients have received proper treatment within two weeks from the onset of stroke symptoms. Age between 18 to 70 years old for men or women Patients with persistent neurological deficit . Obtaining informed consent signed (after being informed of the purpose, procedure, and venture of this study, the patient or guardian or legal representative must signing the informed consent document for engagement of participation. Patients basic situation are allowable to be involved in the program. Exclusion Criteria: Patients with serious extensive stroke, who are unwilling to the risk. Patients with serious persistent neurological deficit (NIHSS > 24). Medical history of neurological pathology with a deficit as consequence (Rankin < 3 before stroke). Patients with serious psychological disease. Patients with myocardial infarction in recent 3 months. Patients with recurring thromboembolic disease in recentin recent 3 months. Patients with organ transplantation. Patients with infection history including Human Immunodeficiency Virus(HIV),Human T-cell Leukemia Virus(HTLV), Hepatitis B Virus(HBV), Hepatitis C Virus(HCV),ect. Patients receive current immunosuppressive/immunomodulating treatment. Patients basic situation are unallowable to be involved in the program. Patients who refuse to participate. Patients who are inability or unwillingness of individual or legal guardian/representative to give written informed consent. Patients who are pregnant or feeding women. Patients who are Participating in another therapeutic clinical trial or in period of exclusion of a therapeutic clinical study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li De Sheng, P.H.D
Phone
13811435365
Ext
011-86-126
Email
deshengli301@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Huang Min, B.S
Phone
18310706110
Ext
011-86-126
Email
871803864@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Duan Lian, P.H.D
Organizational Affiliation
Director and Professor, Department of Neurosurgery, Affiliated Hospital(307 Hospital), Academy of Military Medical Science, Beijing, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neurosurgery,Affiliated Hospital of Academy of Military Medical Sciences(307 Hospital)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100071
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
25449888
Citation
Cheng Q, Zhang Z, Zhang S, Yang H, Zhang X, Pan J, Weng L, Sha D, Zhu M, Hu X, Xu Y. Human umbilical cord mesenchymal stem cells protect against ischemic brain injury in mouse by regulating peripheral immunoinflammation. Brain Res. 2015 Jan 12;1594:293-304. doi: 10.1016/j.brainres.2014.10.065. Epub 2014 Nov 6.
Results Reference
background
PubMed Identifier
24444827
Citation
Tsuji M, Taguchi A, Ohshima M, Kasahara Y, Sato Y, Tsuda H, Otani K, Yamahara K, Ihara M, Harada-Shiba M, Ikeda T, Matsuyama T. Effects of intravenous administration of umbilical cord blood CD34(+) cells in a mouse model of neonatal stroke. Neuroscience. 2014 Mar 28;263:148-58. doi: 10.1016/j.neuroscience.2014.01.018. Epub 2014 Jan 18.
Results Reference
background
PubMed Identifier
23583051
Citation
Verina T, Fatemi A, Johnston MV, Comi AM. Pluripotent possibilities: human umbilical cord blood cell treatment after neonatal brain injury. Pediatr Neurol. 2013 May;48(5):346-54. doi: 10.1016/j.pediatrneurol.2012.10.010.
Results Reference
background
PubMed Identifier
19938343
Citation
Yalvac ME, Rizvanov AA, Kilic E, Sahin F, Mukhamedyarov MA, Islamov RR, Palotas A. Potential role of dental stem cells in the cellular therapy of cerebral ischemia. Curr Pharm Des. 2009;15(33):3908-16. doi: 10.2174/138161209789649439.
Results Reference
result
Links:
URL
http://journal.hep.com.cn/fmd/EN/Y2015/V9/I1/20
Description
This review article provides an update role of hUC-MSCs implantation in the treatment of ischemic stroke.
URL
http://www.nature.com/pr/journal/v72/n3/full/pr201271a.html
Description
Human umbilical cord blood-derived mesenchymal stem cell transplantation attenuates severe brain injury by permanent middle cerebral artery occlusion in newborn rats

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Umbilical Cord Derived Mesenchymal Stem Cells Treatment in Ischemic Stroke

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