Safety/Feasibility of Autologous Mononuclear Bone Marrow Cells in Stroke Patients

Completed · Phase 1

Conditions studied: Ischemic Stroke

In brief

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.

Key facts

Study ID

NCT00859014

Run by

The University of Texas Health Science Center, Houston

People needed

25

Starts

2009-01-01

Expected to finish

2013-11-01

Last updated by the study team

2015-01-01

Who can join

Age: 18 and older, up to 83. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• acute ischemic stroke
• age 18 to 83 years If >80 then the pre-stroke mRS needs to be < 1)
• Right hemisphere NIHSS 6 -15, left hemisphere NIHSS 6-18
• known onset time of acute symptoms
• stem cell transplantation procedure must be performed within 24 to 72 hrs after stroke symptom onset
• TPA infusion is allowed

You may not qualify if…

• NIHSS 1a > 1
• pre-stroke mRS > 1 if > 80 years of age
• Ischemic stroke in the last 3 months, any vascular territory
• 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.
• 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 >1.6 mg/dL at admission
• pulmonary disease (e.g, COPD with oxygen-requirement at rest or with ambulation, moderate to severe asthma)
• mechanical heart valve
• 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.
• prior immunosuppression, including chemotherapy administration within last 3 years or current immunosuppression as defined by WBC <3 x 103 cells/ml
• known HIV
• hemoglobin <10g/dl
• uncorrected coagulopathy at the time of consent defined as INR >1.4; PTT>37 sec, or thrombocytopenia (PLT<100,000)
• any hemodynamic instability at the time of consent (e.g, requiring continuous fluid resuscitation or ionotropic support).
• 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.
• pregnancy or positive b-HCG
• current participation in any interventional research study
• unable to return for follow-up visits for clinical evaluation, laboratory studies, or imaging evaluation
• Multiple anti-platelet medications (Aggrenox is considered a single platelet agent)
• Unable to undergo MRI or CT scan
• Any other condition that the investigator feels would pose a significant hazard to the patient if enrolled.
• 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.
• Exclude IA therapy use or if there is a planned or anticipated hemicraniectomy. Diagnostic angiograms are allowed

Where it is running

• Memorial Hermann Hospital-Medical Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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