Safety/Feasibility of Autologous Mononuclear Bone Marrow Cells in Stroke Patients
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke
Intervention: Autologous Bone Marrow Mononuclear Cells
Intervention description: Harvest of bone marrow from ischemic stroke patients, isolation of bone marrow mono-nuclear cells, and peripheral IV infusion of autologous bone marrow mono-nuclear cells
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 83 Years
Healthy volunteers: No

Summary:

      The purpose of this research study is to find out if bone marrow treatment (bone marrow
      aspiration and infusion of stem cells) can be safely used in adults who have recently (within
      24-72 hours)suffered an acute ischemic stroke.
    

Eligibility criteria:

        Inclusion Criteria:

          1. acute ischemic stroke

          2. age 18 to 83 years If >80 then the pre-stroke mRS needs to be < 1)

          3. Right hemisphere NIHSS 6 -15, left hemisphere NIHSS 6-18

          4. known onset time of acute symptoms

          5. stem cell transplantation procedure must be performed within 24 to 72 hrs after stroke
             symptom onset

          6. TPA infusion is allowed

        Exclusion Criteria:

          1. NIHSS 1a > 1

          2. pre-stroke mRS > 1 if > 80 years of age

          3. Ischemic stroke in the last 3 months, any vascular territory

          4. MI, primary hemorrhagic or traumatic lesion of the brain within the last 3 months or
             identified on MRI. Small hemorrhagic transformation of the acute infarct is allowed.

          5. seizure disorder

          6. developmental delay

          7. chronic kidney disease defined as baseline creatinine >1.4

          8. hepatic disease or altered liver function as defined by SGPT >150 U/L and or T.
             Bilirubin >1.6 mg/dL at admission

          9. pulmonary disease (e.g, COPD with oxygen-requirement at rest or with ambulation,
             moderate to severe asthma)

         10. mechanical heart valve

         11. Active malignancy or diagnosis of malignancy within 5 years prior to the start of
             screening or any history of chemotherapy or radiation affecting the bone marrow. Skin
             cancers (except for melanoma) are permitted.

         12. prior immunosuppression, including chemotherapy administration within last 3 years or
             current immunosuppression as defined by WBC <3 x 103 cells/ml

         13. known HIV

         14. hemoglobin <10g/dl

         15. uncorrected coagulopathy at the time of consent defined as INR >1.4; PTT>37 sec, or
             thrombocytopenia (PLT<100,000)

         16. any hemodynamic instability at the time of consent (e.g, requiring continuous fluid
             resuscitation or ionotropic support).

         17. Hypoxemia (SaO2<90%) at the time of consent, respiratory distress or persistent
             hypoxemia defined as SaO2 <94% for >30 minutes occurring at any time from hospital
             admission to time of consent. Intubation alone is not an exclusion.

         18. pregnancy or positive b-HCG

         19. current participation in any interventional research study

         20. unable to return for follow-up visits for clinical evaluation, laboratory studies, or
             imaging evaluation

         21. Multiple anti-platelet medications (Aggrenox is considered a single platelet agent)

         22. Unable to undergo MRI or CT scan

         23. Any other condition that the investigator feels would pose a significant hazard to the
             patient if enrolled.

         24. Exclude infarct lesion size >145cc unless the NIHSS 1a remains < 1 and there is no
             evidence of infarct expansion or edema formation on any imaging obtained from
             admission up to the point just prior to infusion.

         25. Exclude IA therapy use or if there is a planned or anticipated hemicraniectomy.
             Diagnostic angiograms are allowed

         26. CT and/or Multimodal MRI exclusion criteria will be:

               -  hemispheric strokes < 1.5 cm maximum diameter (on the MRI as seen on the
                  diffusion-weighted imaging or CT)

               -  midline shift >1mm or significant hemorrhagic transformation of the acute infarct