Safety/Feasibility of Autologous Mononuclear Bone Marrow Cells in Stroke Patients
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ClinicalTrials.gov Identifier: NCT00859014 |
Recruitment Status :
Completed
First Posted : March 10, 2009
Results First Posted : January 1, 2015
Last Update Posted : January 1, 2015
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Condition or disease | Intervention/treatment | Phase |
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Ischemic Stroke | Biological: Autologous Bone Marrow Mononuclear Cells | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 25 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Safety/Feasibility of Autologous Mononuclear Bone Marrow Cells in Stroke Patients |
Study Start Date : | January 2009 |
Actual Primary Completion Date : | November 2013 |
Actual Study Completion Date : | November 2013 |

Arm | Intervention/treatment |
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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.
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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 |
- Study Related Serious Adverse Events (SR-SAE) [ Time Frame: 2 Years ]Study Related Serious Adverse Events (SAE) as adjudicated by the DSMB - "Events"
- Functional Outcome [ Time Frame: 90-days ]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.

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Ages Eligible for Study: | 18 Years to 83 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00859014
United States, Texas | |
Memorial Hermann Hospital-Medical Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Sean I Savitz, MD | University of Texas Heath Science Center- Houston |
Other Publications:
Responsible Party: | Sean Savitz, Professor, Neurology, The University of Texas Health Science Center, Houston |
ClinicalTrials.gov Identifier: | NCT00859014 |
Other Study ID Numbers: |
N01-HB-37163-05 R21HD060978 ( U.S. NIH Grant/Contract ) |
First Posted: | March 10, 2009 Key Record Dates |
Results First Posted: | January 1, 2015 |
Last Update Posted: | January 1, 2015 |
Last Verified: | December 2014 |
Stroke Ischemic Stroke Cerebrovascular Disorders Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases |