Safety of Autologous Bone Marrow Cell Treatment for Acute Ischemic Stroke
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Status:
This study has been completed.
Purpose:
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.
Interventions:
Autologous stem cell
Stem cells from the patient's own blood or bone marrow are retrieved and given back to the patient.
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Location(s):
Houston, Texas
Year Started:
2009
Design:
Interventional, Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study.
Inclusion Criteria
Acute ischemic stroke; NIHSS 6 to 20; known onset time of acute symptoms; based upon published preclinical studies, stem cell transplantation procedure must be performed within 24 to 72 hrs after stroke symptom onset; multimodal MRI inclusion criteria will be hemispheric strokes in the MCA circulation, > 2.5 cm maximum diameter on diffusion-weighted imaging, no midline shift, no hemorrhage, and infarct size less than or equal to 100 cc.
Exclusion Criteria
>70 yo; eligible for treatment with rt-PA within the therapeutic treatment window or experimental therapies that include intra-arterial or endovascular therapies; any prior hemorrhagic, ischemic, or traumatic lesion of the brain
seizure disorder; developmental delay; chronic kidney disease defined as baseline creatinine >1.4; hepatic disease or altered liver function as defined by SGPT >150 U/L and or T. Bilirubin >1.3 mg/dL at admission; pulmonary disease (e.g, COPD with oxygen-requirement at rest or with ambulation, moderate to severe asthma); mechanical heart valve; cancer; prior immunosuppression, including prior chemotherapy administration or current immunosuppression as defined by WBC <3 x 10^3 cells/ml; known HIV; hematocrit <10g/dl;
uncorrected coagulopathy at the time of consent defined as INR >1.4; PTT>35 sec, or thrombocytopenia (PLT<100,000)
any hemodynamic instability at the time of consent (e.g, requiring continuous fluid resuscitation or ionotropic support), or hypoxemia (SaO2<90%); persistent hypoxemia defined as SaO2 <94% for >30 minutes occurring at any time from hospital admission to time of consent; pregnancy or positive b-HCG; current participation in any formal research study; unable to return for follow-up visits for clinical evaluation, laboratory studies, or MRI evaluation; patients on anticoagulation. Single antiplatelet agents will not be an exclusion criterion but if the patients are on more than one antiplatelet agent, they will be excluded; history of myocardial infarction or evidence of old MI on EKG; history of a transient ischemic attack defined as history of a transient episode of aphasia, limb weakness, or visual loss;
unable to undergo MRI scan due to metal implant, claustrophobia refractory to anti-anxiety medication, weight greater than 300 pounds, or maximum circumference of 22.5 inches.
Patient Involvement:
Patient will have MRI to confirm diagnosis, NIHSS 6 to 20 and baseline lab tests. Peripheral IV infusion of autologous stem cell within 24 to 72 hours of diagnosis. Follow-up per physician direction, at 3 months and for 5 years.
Primary Outcome:
Safety and feasibility of bone marrow mononuclear cell autologous (stem cell) transplantation in patients with acute stroke.
Secondary Outcome:
Functional outcome at 3 months.
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Source of Information:
ClinicalTrials.gov
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Web Links and Publications:
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This information last updated on: 10/5/2009
Reviewed on: 05/05/2009.
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