Phase
Condition
Stroke
Cerebral Ischemia
Occlusions
Treatment
N/AClinical Study ID
Ages 30-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Have the ability to understand the requirements of the study, provide written informedconsent, understand and provide written authorization for the use and disclosure ofProtected Health Information (PHI) [per Health Insurance Portability andAccountability Act (HIPAA) Privacy Ruling] and comply with the study procedures
Men and women 30-65 years old
Women must have a negative serum pregnancy test and practice an acceptable method ofcontraception or be of non-childbearing potential (post-menopausal for at least 2years or who have undergone hysterectomy or oophorectomy or surgical sterilization)
At least 3 months but no more than 24 months from time of stroke, with a motorneurological deficit
Documented history of completed ischemic stroke in subcortical region of MCA orlenticulostriate artery with or without cortical involvement, with correlated findingsby MRI
Modified Rankin Score of 2, 3 or 4
FMMS score of 55 or less;
Two evaluations at approximately 3 weeks apart prior to surgery with less than +/- 4point change in the NIHSS
Able and willing to meet all follow-up requirements
Able and willing to undergo post-physical therapy/rehabilitation
Exclusion
Exclusion Criteria:
Any disabling psychological or psychiatric disorders which may confound the study
History of more than one symptomatic stroke, TIAs allowed
History of another major neurological disease or injury
Cerebral infarct size >8cm in any one measurement
Myocardial infarction within the prior 3 months
History of seizures or current use of antiepileptic medication
Receipt of any investigational drug or device within 30 days
Receipt of any cell infusion other than blood transfusion
Any concomitant medical disease or condition noted below:
Coagulopathy with INR > 1.4 at the time of surgery
Panel Reactive Antibodies (PRA) > 20% at initial screen
Active infection at the time of surgery
Active hypotension requiring vasopressor therapy
Skin breakdown over the site of surgery
Active or history of malignancy
Primary or secondary immune deficiency
Persistent MRI artifact that would prevent imaging pre and post-operation orunable to undergo MRI
Creatinine >115μmol/L, liver function tests (SGOT/SGPT, Bilirubin, Alk Phos) > 2xupper limit of normal, hematocrit/hemoglobin < 30/10, total WBC < 4000/mm3,platelet count <100,000/mm3, uncontrolled hypertension (systolic > 180mmHg or diastolic> 100mmHg) or uncontrolled diabetes (defined as hemoglobinA1C>8%), evidence of GI bleeding by hemoccult test,positive tuberculosis (TBtest: PPD/Mantoux), hepatitis B or C, or human immunodeficiency virus (HIV)
Presence of any of the following conditions:
Current drug abuse or alcoholism
Unstable medical conditions
Unstable psychiatric illness including psychosis and untreated major depression
Any condition that the Investigator or primary physician feels may interfere withparticipation in the study or may endanger the subject
Any condition that the surgeon feels may pose complications for the surgery
Known hypersensitivity to tacrolimus or methylprednisolone
Unable or unwilling to participate in physical and/or occupational therapy or returnto clinic for follow up examinations as scheduled
Inability to provide informed consent as determined by screening protocol.
Use of antiplatelet drugs less than 2 weeks before surgery
Study Design
Study Description
Connect with a study center
Ba Yi Brain Hospital
Beijing,
ChinaSite Not Available

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.