Autologous Hematopoietic Stem Cell Transplantation in Ischemic Stroke (AHSCTIS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Zhejiang Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Zhejiang University
Information provided by (Responsible Party):
Yaguo Li, Zhejiang Hospital
ClinicalTrials.gov Identifier:
NCT01518231
First received: January 10, 2012
Last updated: January 24, 2012
Last verified: January 2012

January 10, 2012
January 24, 2012
January 2012
December 2012   (final data collection date for primary outcome measure)
Change from Baseline in NIH-stroke scale (NIHSS) at 12 months [ Time Frame: 1,3,6,12 months after cell transplantation ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01518231 on ClinicalTrials.gov Archive Site
  • Barthel index [ Time Frame: 1,3,6,12 months after cell transplantation ] [ Designated as safety issue: Yes ]
  • perfusion magnetic resonance imaging scan [ Time Frame: 1,3,6,12 months after cell transplantation ] [ Designated as safety issue: Yes ]
  • Modified Rankin Scale(mRS) [ Time Frame: 3,6,12 months after cell transplantation ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Autologous Hematopoietic Stem Cell Transplantation in Ischemic Stroke
Phase 1 Study of Autologous Peripheral Hematopoietic Stem Cell Transplantation in Ischemic Stroke

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

Stroke is among the main causes of mortality and disability of elderly population which still lack of efficient therapy. Stem sell transplantation provides a functional improvement after cerebral ischemia in rat models. Our study will recruit 40 ischemic stroke patients which will be divided into 2 groups (20 patients each): treatment group and control group. The former will be implanted with peripheral blood stem cell through anterior cerebral artery or middle cerebral artery (determined by the section of infarction) and receive convention stroke therapy. The latter only receive convention stroke therapy. The investigators expect that transplantation of the peripheral hematopoietic stem cell is safe and efficient to neurological recovery.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Stroke
  • Procedure: autologous hematopoiesis stem cell transplantation
    Every participant will be transplanted with about 4 million autologous peripheral blood stem cell(CD34+) through cerebral artery.
  • Drug: Aspirin
    aspirin 100mg,qd,po(patients with no fibrillation atrial)
  • Drug: Warfarin
    warfarin 2~6mg,qd,po(patients with fibrillation atrial);
  • Drug: Atorvastatin
    atorvastatin 20mg,qd,po
  • Drug: Edaravone
    edaravone 30mg,bid,ivgtt.
  • Drug: Warfarin
    warfarin 2~6mg,qd,po(patients with fibrillation atrial)
  • Drug: Edaravone
    edaravone 30mg,bid,ivgtt
  • Experimental: cell transplantation
    The study group will not only be implanted with autologous hematopoietic stem cells, but also receive drug therapy.
    Interventions:
    • Procedure: autologous hematopoiesis stem cell transplantation
    • Drug: Aspirin
    • Drug: Warfarin
    • Drug: Atorvastatin
    • Drug: Edaravone
  • No Intervention: Convention therapy
    The control group just receive drug therapy.
    Interventions:
    • Drug: Aspirin
    • Drug: Warfarin
    • Drug: Atorvastatin
    • Drug: Edaravone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
December 2013
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Both
40 Years to 70 Years
No
Contact: Yaguo Li, master 0086-0571-87987373 ext 5103 tjqlyg@163.com
Contact: Yumiao Zhou, master 0086-0571-87987373 ext 5094 zlf859@yahoo.com.cn
China
 
NCT01518231
Zhejiang Hospital
No
Yaguo Li, Zhejiang Hospital
Zhejiang Hospital
Zhejiang University
Study Director: Yaguo Li, master Zhejiang Hospital
Principal Investigator: Yumiao Zhou, master Zhejiang Hospital
Zhejiang Hospital
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP