Safety/Feasibility of Autologous Mononuclear Bone Marrow Cells in Stroke Patients
This study has been completed.
Information provided by (Responsible Party):
Sean Savitz, The University of Texas Health Science Center, Houston
First received: March 9, 2009
Last updated: December 31, 2014
Last verified: December 2014
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.
Biological: Autologous Bone Marrow Mononuclear Cells
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Safety/Feasibility of Autologous Mononuclear Bone Marrow Cells in Stroke Patients
Primary Outcome Measures:
Secondary Outcome Measures:
- Functional Outcome [ Time Frame: 90-days ] [ Designated as safety issue: No ]
Modified Rankin Scale (mRS) Score. The mRS is a six point (scored: 0 - 5) scale that measures post stroke disability. A seventh category (mRS = 6) is for patients who have died. A higher score indicates greater degree of disability. Patients scoring '5' are bed ridden, where as those scoring '0' are completely symptom free and independent.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||November 2013 (Final data collection date for primary outcome measure)
Experimental: Autologous Bone Marrow Mononuclear Cells
Harvest of bone marrow from ischemic stroke patients, isolation and purification of mono-nuclear cell fraction from bone marrow, intravenous administration of autologous bone marrow mono-nuclear cells with a targeted dose of 10 million cells / kg.
Biological: Autologous Bone Marrow Mononuclear Cells
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
Our primary hypothesis is that autologous bone marrow mononuclear cell transplantation by intravenous administration is feasible and safe after acute ischemic stroke. Our secondary hypothesis is that autologous transplantation is associated with improved outcome after acute stroke.
|Ages Eligible for Study:
||18 Years to 83 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00859014
|Memorial Hermann Hospital-Medical Center
|Houston, Texas, United States, 77030 |
The University of Texas Health Science Center, Houston
||Sean I Savitz, MD
||University of Texas Heath Science Center- Houston
ClinicalTrials.gov processed this record on March 26, 2015
||Sean Savitz, Professor, Neurology, The University of Texas Health Science Center, Houston
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 9, 2009
|Results First Received:
||December 18, 2014
||December 31, 2014
||United States: Food and Drug Administration