NCT01518231

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of autologous peripheral hematopoietic stem cell transplantation in ischemic 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
40

participants targeted

Target at P50-P75 for phase_1 stroke

Timeline
Completed

Started Jan 2012

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

Study Start

First participant enrolled

January 1, 2012

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 10, 2012

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 25, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

January 25, 2012

Status Verified

January 1, 2012

Enrollment Period

11 months

First QC Date

January 10, 2012

Last Update Submit

January 24, 2012

Conditions

Stroke

Keywords

strokehematopoietic stem cell transplantation

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in NIH-stroke scale (NIHSS) at 12 months

    1,3,6,12 months after cell transplantation

Secondary Outcomes (3)

  • Barthel index

    1,3,6,12 months after cell transplantation

  • perfusion magnetic resonance imaging scan

    1,3,6,12 months after cell transplantation

  • Modified Rankin Scale(mRS)

    3,6,12 months after cell transplantation

Study Arms (2)

cell transplantation

EXPERIMENTAL

The study group will not only be implanted with autologous hematopoietic stem cells, but also receive drug therapy.

Procedure: autologous hematopoiesis stem cell transplantationDrug: AspirinDrug: WarfarinDrug: AtorvastatinDrug: Edaravone

Convention therapy

NO INTERVENTION

The control group just receive drug therapy.

Drug: AspirinDrug: WarfarinDrug: AtorvastatinDrug: Edaravone

Interventions

autologous hematopoiesis stem cell transplantationPROCEDURE

Every participant will be transplanted with about 4 million autologous peripheral blood stem cell(CD34+) through cerebral artery.

cell transplantation
AspirinDRUG

aspirin 100mg,qd,po(patients with no fibrillation atrial)

cell transplantation
WarfarinDRUG

warfarin 2\~6mg,qd,po(patients with fibrillation atrial);

cell transplantation
AtorvastatinDRUG

atorvastatin 20mg,qd,po

cell transplantation
EdaravoneDRUG

edaravone 30mg,bid,ivgtt.

cell transplantation

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged 40\~70
  • no consciousness disorders
  • internal carotid artery territory infarction
  • stroke happened \< 1 year
  • with stable hemiplegia, but remain dependent in daily life
  • SSS(Scandinavian Stroke Scale) \< 40

You may not qualify if:

  • pregnant women
  • can't tolerate the test because of other disease, such as heart failure, liver failure, renal failure, abnormal blood coagulation, AIDS, combine other tumor or special condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yaguo Li

Hangzhou, Zhejiang, 310013, China

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

AspirinWarfarinAtorvastatinEdaravone

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingPyrrolesAzolesHeptanoic AcidsFatty AcidsLipidsAntipyrinePyrazolonesPyrazoles

Study Officials

  • Yaguo Li, master

    Zhejiang Hospital

    STUDY DIRECTOR

  • Yumiao Zhou, master

    Zhejiang Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yaguo Li, master

CONTACT

0086-0571-87987373tjqlyg@163.com

Yumiao Zhou, master

CONTACT

0086-0571-87987373zlf859@yahoo.com.cn

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Yaguo Li

Study Record Dates

First Submitted

January 10, 2012

First Posted

January 25, 2012

Study Start

January 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2013

Last Updated

January 25, 2012

Record last verified: 2012-01

Locations

CN(1)