Autologous Bone Marrow Mononuclear Cell Transplantation for Stroke Patients

N

National Cerebral and Cardiovascular Center

Status and phase

Completed
Phase 2
Phase 1

Conditions

Stroke
Cerebral Embolism

Treatments

Biological: autologous bone marrow mononuclear cells

Study type

Interventional

Funder types

Other

Identifiers

NCT01028794
UMIN000001133 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

20 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

12 participants in 2 patient groups

autologous bone marrow mononuclear cell
Experimental group
Description:
On day 7-10 after stroke, patient has 25ml of bone marrow cells aspiration. Mononuclear cells are purified by Ficoll and administrated intravenously.
Treatment:
Biological: autologous bone marrow mononuclear cells
autologous bone marrow mononuclear cells
Experimental group
Description:
On day 7-10 after stroke, patient has 50ml of bone marrow cells aspiration. Mononuclear cells are purified by Ficoll and administrated intravenously.
Treatment:
Biological: autologous bone marrow mononuclear cells

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems