Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase I Safety Trial of CTX0E03 Drug Product Delivered Intracranially in the Treatment of Patients With Stable Ischemic Stroke
Brief Summary: The study is designed to test the safety of a manufactured neural stem cell line (CTX cells) delivered by injection into the damaged brains of male patients 60 years of age or over who remain moderately to severely disabled 6 months to 5 years following an ischemic stroke. In addition the trial will evaluate a range of potential efficacy measures for future trials. Treatment will involve a single injection of one of four doses of CTX cells into the patient's brain in a carefully controlled neurosurgical operation performed under general anesthetic. The trial is designed to treat 12 patients and measure outcomes over 24 months. Patients will be invited to participate in a long-term follow-up trial for a further 8 years.


Options:
A: Inclusion Criteria:

* Symptoms and signs of clinically definite middle cerebral artery acute stroke.
* Time of stroke onset is known and treatment can be started between day 5 and 9 of onset.
* DWI-MRI has reliably shown relevant acute ischemic lesions
* Extracranial duplex/transcranial Doppler must confirm intra/extracranial arteries permeability.
* The stroke is severe (NIH Stroke Scale \>= 8 before procedure).
* An age range of 18-80 years old.

Exclusion Criteria:

* Patients out of inclusion age range.
* Lacunar infarction.
* Patients with cancer.
* Patients with present or previous malignant disease during the last 5 years, except for basal cell carcinoma.
* Hematological causes of stroke.
* Severe co-morbidity.
* Hepatic or renal dysfunction.
* The patient is female and of childbearing potential (unless it is certain that pregnancy is not possible) or breast feeding.
* Patient is likely to be unavailable for follow-up.
* Patient with evidence of life threatening infection of life threatening illness.
* Patient was already dependent in activities of daily living before the present acute stroke.
B: Inclusion Criteria:

* Males
* 60 years or over
* Unilateral ischemic stroke involving subcortical white matter or Basal Ganglia 6 months to 5 years before entry
* NIHSS score minimum 6 with hemiparesis (2 or more for motor arm and leg)
* Neurologically stable for 2 m
* modified Rankin score of 2-4
* Fit for general anesthesia, neurosurgery
* Capacity to consent
* Infarct at least 1cm diameter

Exclusion Criteria:

* Structural brain vascular lesions requiring surgery or increasing the risk of stereotaxic implantation
* Unstable medical conditions with expected survival \<12 months
* Any medical condition that would impair participation (eg progressive neurological disorders, mental illness)
* Major surgery within 30 days
* Previous allogeneic tissue transplant
* MMSE \< 24
* Epilepsy
* Coagulation disorders or anticoagulant treatment that cannot be interrupted
* Stimulants, botox, tamoxifen
* Contraindications to MRI
C: Inclusion Criteria:

1. Sudden onset of focal neurologic deficit or impairment of consciousness.
2. CT or MRI scan of head showing no haematoma and relevant lesions within the MCA and ACA territory.
3. Age between 30 -70 years (after amendment 18 -70 years).
4. \>7 to \</=30 days passed since the onset of the qualifying event.
5. Glasgow Coma Scale score of \>8 at the time of randomization, in aphasic Eye and Motor score of \>6.
6. Modified Barthel Index score of 50 or less at the time of randomization.
7. NHISS score of 7 or more points and inability to walk unaided or raise upper limb by 90 degree.
8. Patient is stable. ( normal respiration, afebrile, BP less than mean arterial pressure of 125 mm of Hg, fasting blood sugar \< 200 mg% and normal urea/electrolytes for at least 48 hours.)

Exclusion Criteria: -

1. Lacunar syndrome
2. Intubation
3. Posterior circulation stroke
4. Co morbidity likely to limit survival to less than 3 years eg. Hepatic or renal failure.
5. Inaccessibility for follow up.
6. Allergy to local anaesthetic.
7. Unwillingness to provide written informed consent.
8. Symptom of acute myocardial infarction or acute involvement of any other organ.
9. Pregnancy 10. HIV positive 11. Patient is a part of any other trial in last 6 months.
D: Inclusion Criteria:

* males and females
* above 18 years of age
* diagnosed as stroke by clinical and MRI findings

Exclusion Criteria:

* presence of respiratory distress
* presence of acute infections such as Human Immunodeficient Virus/Hepatitis B Virus/Hepatitis C Virus
* malignancies
* acute medical conditions such as respiratory infection, fever
* hemoglobin less than 8
* bleeding tendency
* bone marrow disorder
* left ventricular ejection fraction \< 30%
* pregnancy or breastfeeding

Answer: B