Please select the eligibility criteria that correspond to the clinical trial below.
Title: Intravenous Administration of Autoserum-cultured Autologous Mesenchymal Stem Cells in Ischemic Stroke: A Single Center, Randomized, Open Label, Prospective, Phase 3 Study
Brief Summary: The objectives of this study was to test hypothesis that ischemic stroke patients having moderate to severe persistent neurologic deficit will have better outcomes with intravenous transplantation of autologous mesenchymal stem cells (MSCs) expanded with autologous serum that is obtained at acute phase of stroke than patients receiving standard treatment.


Options:
A: 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.
B: 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.
C: 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
D: Inclusion Criteria:

1. Men or women (women must be of non-child bearing potential), age 30-75 yrs.
2. Have a stroke that is observed within 90 days of the onset of symptoms
3. Radiologically

   1. Relevant lesions within the middle cerebral artery territory (MCA) as assessed using diffusion-weighted imaging (DWI).
   2. The maximum diameter of the stroke region in any dimension must be ≥15 mm.
   3. Not involving more than a half of the ipsilateral periventricular zone
4. Clinically (National Institutes of Health stroke scale, NIHSS)

   1. Moderate-to severe persistent neurologic deficit (NIHSS of 6-21 inclusive)
   2. New onset of extremity paresis on the affected side, defined as a score of 2-4 on the NIHSS Motor Arm (item 5) or Leg (item 6) question.
   3. Must be alert or drowsy but easily arousable as defined by score of 0-1 on the NIHSS Level of Consciousness question (item 1).
   4. "Slow recovery" defined as Change in NIHSS ≤1 point/3 days
5. Willingness

   1. Reasonable likelihood of receiving standard physical, occupational and speech rehabilitation therapy as indicated for the post stroke deficits.
   2. Able to participate in the evaluation process to the point of accurate assessment.
   3. Willing and able to comply with scheduled visits, lifestyle guidelines, treatment plan, laboratory tests, and other study procedures.
   4. Evidence of a personally signed and dated informed consent document.

Exclusion Criteria:

1. Presence of significant disability prior to the current stroke. Significant disability is defined as having a pre-stroke modified Rankin score of 2 or more.
2. Have a stroke that is either

   1. lacunar infarction
   2. Hematologic cause of stroke
   3. Recurrent or progressive stroke within 1 week at the time of screening.
3. Hematologic disorders or bone marrow suppression.
4. Have a severe medical illness

   1. Severe heart failure
   2. Severe febrile illness
   3. Hepatic or renal dysfunction
   4. Active cancer
   5. Any evidence of chronic co-morbid condition or unstable acute systemic illnesses which, in the opinion of the investigator, could shorten the subject's survival or limit ability to complete the study.
5. Presence of human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), or syphilis on admission blood tests
6. Presence of depression that is active and not adequately controlled such that it interfere with major activities of daily living immediately prior to the current stroke.
7. Presence of dementia prior to the current stroke that is likely to confound clinical evaluation.
8. Pregnant females as determined by positive urine human chorionic gonadotropin (hCG) test or lactating females.
9. Subjects considered unwilling or unable to comply with the procedures and study visit schedule outlined in the protocol
10. Subjects unwilling to undergo bone marrow aspiration

Answer: D