NCT01028794

Brief Summary

The purpose of this study is to determine whether autologous bone marrow mononuclear cells transplantation after stroke is safe and/or effective to improve neurological outcome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2008

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 2008

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

December 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 9, 2009

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

July 8, 2013

Status Verified

July 1, 2013

Enrollment Period

5.2 years

First QC Date

December 8, 2009

Last Update Submit

July 4, 2013

Conditions

Cerebral EmbolismStroke

Keywords

strokebone marrowmononuclear cellangiogenesisneurogenesis

Outcome Measures

Primary Outcomes (2)

  • Improvement of NIHSS（National Institute of Health Stroke Scale）

    30 days after treatment

  • Frequency of change for the worse in NIHSS

    30 days aftrer treatment

Secondary Outcomes (2)

  • Mean level of mRS (modified Rankin Scale)

    30 days after treatment

  • Frequency of death

    day 30 after treatment

Study Arms (2)

autologous bone marrow mononuclear cell

EXPERIMENTAL

On day 7-10 after stroke, patient has 25ml of bone marrow cells aspiration. Mononuclear cells are purified by Ficoll and administrated intravenously.

Biological: autologous bone marrow mononuclear cells

autologous bone marrow mononuclear cells

EXPERIMENTAL

On day 7-10 after stroke, patient has 50ml of bone marrow cells aspiration. Mononuclear cells are purified by Ficoll and administrated intravenously.

Biological: autologous bone marrow mononuclear cells

Interventions

autologous bone marrow mononuclear cellsBIOLOGICAL

intravenous administration of autologous bone marrow derived mononuclear cells obtained from 25ml of bone marrow on day 7-10 after stroke (only once in that period)

autologous bone marrow mononuclear cell

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with cerebral embolism.
  • NIHSS score is more than (or equal to) 10.
  • On day 7 after onset of stroke, the improvement of NIHSS is less than (or equal to) 5, compared with the level at administration.
  • Bone marrow aspiration can be done in 10 days after onset of stroke

You may not qualify if:

  • Patient with cerebral hemorrhage or symptomatic hemorrhagic infarction.
  • Patient who expects brain surgery.
  • Patient with acute myocardial infarction.
  • Patient with coagulation disorder.
  • Number of Platelet \< 100000/mm3
  • Serum creatinine level \>2.0mg/dl
  • Patient with malignancy.
  • Patient with uncontrolled proliferative diabetic retinopathy.
  • Patient suspected infective endocarditis.
  • HBV, HCV, HIV or HTLV positive

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cerebrovascular Disease, National Cardiovascular Center

Suita, Osaka, 565-8565, Japan

Location

Related Publications (4)

  • Taguchi A, Soma T, Tanaka H, Kanda T, Nishimura H, Yoshikawa H, Tsukamoto Y, Iso H, Fujimori Y, Stern DM, Naritomi H, Matsuyama T. Administration of CD34+ cells after stroke enhances neurogenesis via angiogenesis in a mouse model. J Clin Invest. 2004 Aug;114(3):330-8. doi: 10.1172/JCI20622.

    PMID: 15286799BACKGROUND

  • Taguchi A, Ohtani M, Soma T, Watanabe M, Kinosita N. Therapeutic angiogenesis by autologous bone-marrow transplantation in a general hospital setting. Eur J Vasc Endovasc Surg. 2003 Mar;25(3):276-8. doi: 10.1053/ejvs.2002.1831. No abstract available.

    PMID: 12623341BACKGROUND

  • Taguchi A, Matsuyama T, Moriwaki H, Hayashi T, Hayashida K, Nagatsuka K, Todo K, Mori K, Stern DM, Soma T, Naritomi H. Circulating CD34-positive cells provide an index of cerebrovascular function. Circulation. 2004 Jun 22;109(24):2972-5. doi: 10.1161/01.CIR.0000133311.25587.DE. Epub 2004 Jun 7.

    PMID: 15184275BACKGROUND

  • Taguchi A, Wen Z, Myojin K, Yoshihara T, Nakagomi T, Nakayama D, Tanaka H, Soma T, Stern DM, Naritomi H, Matsuyama T. Granulocyte colony-stimulating factor has a negative effect on stroke outcome in a murine model. Eur J Neurosci. 2007 Jul;26(1):126-33. doi: 10.1111/j.1460-9568.2007.05640.x.

    PMID: 17614944BACKGROUND

MeSH Terms

Conditions

Intracranial EmbolismStroke

Condition Hierarchy (Ancestors)

Intracranial Embolism and ThrombosisCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesThromboembolismEmbolism and Thrombosis

Study Officials

  • Akihiko Taguchi, MD.PhD

    Department of Cerebrovascular Disease, National Cardiovascular Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 8, 2009

First Posted

December 9, 2009

Study Start

May 1, 2008

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

July 8, 2013

Record last verified: 2013-07

Locations

JP(1)