NCT01438593

Brief Summary

The purpose of the study is to determine the safety and possible effectiveness of brain transplants of CD34+ stem cells obtained from umbilical cord blood (UCB) to treat stroke.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2011

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 22, 2011

Completed
1.3 years until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

August 2, 2012

Status Verified

December 1, 2011

Enrollment Period

11 months

First QC Date

September 7, 2011

Last Update Submit

July 31, 2012

Conditions

Ischemic StrokeIschaemic Cerebral InfarctionInfarction, Middle Cerebral ArteryIschemiaBrain Ischemia

Keywords

StrokeBrain diseaseIschemiaCerebral infractionCord Blood

Outcome Measures

Primary Outcomes (4)

  • Change from baseline in NIH Stroke Scale (NIHSS)

    Evaluate change from Baseline in NIHSS at 1 week

    Change from baseline in NIHSS at 1 weeks

  • Change from Baseline in NIH Stroke Scale(NIHSS)

    Evaluate change from Baseline in NIHSS at 2 weeks

    Change from Baseline in NIHSS at 2 weeks

  • Change from baseline in NIH Stroke Scale

    Evaluate change from baseline in NIHSS at 4 weeks

    Change from baseline in NIHSS at 4 weeks

  • Change from baseline in NIH Stroke Scale ( NIHSS)

    Evaluate change from baseline in NIHSS at 12 weeks

    Change from baseline in NIHSS at 12 weeks

Secondary Outcomes (3)

  • Change from baseline in Brain Image

    Change from baseline in Brain Image at 1 week

  • Change from baseline in Brain Image

    Change from baseline in Brain Image at 4 weeks

  • Change from baseline in Brain Image

    Change from baseline in Brain Image at 6 months

Study Arms (1)

HUCB, Medicine, Rehabilitation

EXPERIMENTAL

Stroke patients are received intracerebral implantation of human cord blood stem cells (CD34+), Antiplatelet Medication, and Rehabilitation.

Procedure: Intercerebral implantation of allogenic CD34+ stem cell

Interventions

Intercerebral implantation of allogenic CD34+ stem cellPROCEDURE

Each patient will receive brain implant of approximately 5 million allogenic Umbilical cord blood CD34+ Stem Cell

Also known as: Hematopoietic stem cell, Cord Blood Stem Cell, UCB Stem Cell
HUCB, Medicine, Rehabilitation

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects can be of either gender and must be between 35 through 75 years of age.
  • Subjects must have had ischemic stroke more than 6 and less than 60 months ago.
  • Subjects must have stable hemiplegia or hemiparesis condition at least for 3 months.
  • Subjects must have stroke-induced clinical deficits affecting motor, perceptual, or language functions, with a National Institutes of Health Stroke Scale (NIHSS) of 5-15.
  • Subjects must have stroke in the middle cerebral artery territory.
  • Subjects must have an available umbilical cord blood unit that has an HLA-match of at least 5:6 (HLA-A, -B, and -DR).
  • Subjects must be able to read and understand the informed consent form that has been approved by the appropriate Institutional Review Board (IRB). The subject must sign and date the informed consent form before any study-specific procedures. (Note: If a subject consents to participation but is not in a position to sign and date the informed consent form personally because of his or her physical conditions, the consent form must be confirmed orally at the time of consent, marked or finger printed by the subject voluntarily). The informed consent procedure must be observed by an independent witness who is present throughout the whole informed consent process and sign the consent form.

You may not qualify if:

  • Subject has evidence of a non-ischemic mechanism, subarachnoid hemorrhage, primary intracerebral or intraventricular hemorrhage or MRI has shown that the occlusion is not in the middle cerebral artery territory.
  • Pregnant or lactating women.
  • History of alcohol or drug abuse in the previous 3 months.
  • Subjects must not have the following conditions in documents:
  • significant renal, cardiovascular, hepatic, or psychiatric disease
  • abnormal blood coagulation parameters,
  • immunodeficiency (e.g. AIDS)
  • tumors, leukemia, and other cancer that may interfere with the clinical trial protocol
  • infectious diseases, including hepatitis, or other conditions that may be a contraindication to the planned therapies and evaluation.
  • Subject must not be currently participating in another investigational study or taking any investigational drug within the last four weeks before the screening of this study.
  • Any other condition that, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol and would not be suitable to perform a surgery or to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University Hospital

Taichung, Taiwan, 244, Taiwan

Location

MeSH Terms

Conditions

Ischemic StrokeInfarction, Middle Cerebral ArteryIschemiaBrain IschemiaStrokeBrain Diseases

Interventions

Cord Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesCerebral InfarctionBrain InfarctionCerebral Arterial DiseasesIntracranial Arterial DiseasesInfarctionPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Stem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Shinn-Zong Lin, M.D.;PhD.

    China Medical University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Woei-Cherng Shyu, M.D.;PhD.

CONTACT

886-4-22052121Shyu9423@gmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Neurosurgery, China Medical University

Study Record Dates

First Submitted

September 7, 2011

First Posted

September 22, 2011

Study Start

January 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

August 2, 2012

Record last verified: 2011-12

Locations

TW(1)