Stem Cells Trial in Acute Ischemic Stroke
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What? Clinical trial evaluating 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.
Where? Participants receive care at the Memorial Hermann Hospital-Medical Center in Houston, Texas.
Why? To evaluate the safety and feasibility of bone marrow mononuclear cell autologous (stem cell) transplantation in patients with acute stroke, and determine the functional outcome.
How? Peripheral IV infusion of autologous stem cell
When? This 5 year study is currently accepting patients. Patients will be required to travel to the Memorial Hermann Hospital-Medical Center in Houston, TX for the procedure and for follow-up evaluation over the treatment period.
Who may participate? Patients must meet the following criteria:
1) Acute ischemic stroke
2) Age 18 to 80 years
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 and IA therapy is allowed
Who may not participate? Patients may not participate if they meet the following criteria, or others:
1) NIHSS 1a > 1
2) Ischemic stroke in the past 3 months, any vascular territory
3) Myocardial infarction in the past 3 months
4) 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 within last 3 years or current immunosupression 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 or Imaging.
21) Multiple anti-platelet medications (Aggrenox® is considered a single platelet agent.)
22) Any other condition that the investigator feels would pose a significant hazard to the patient if enrolled.
23) 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.
24) CT and/or Multimodal MRI exclusion criteria will be: hemispheric strokes < 2.5 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
Primary Invetsigator:
Dr. Sean Savitz
University of Texas - Houston Medical School
For more information:
Susan E. Alderman, RN, BSN
Email:
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