A Phase 1 interventional study of autologous bone marrow mononuclear cell transfusion and marrow stromal cells in Stroke, sponsored by University of California, Irvine. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2016-02-04.
Sponsored by University of California, Irvine · Phase 1, Interventional, and Treatment
This study will examine the safety of two different cellular therapies in the treatment of stroke.
Stroke remains a leading cause of death and disability. A limited number of therapies, such as intravenous tissue plasminogen activator, have been approved to interrupt stroke in the early hours after symptom onset. Many patients are not able to benefit from these therapies, however, and so a need exists for development of new interventions to reduce disability after stroke. This study will be an early step towards this, and will examine the safety of two cell types, mononuclear cells and marrow stromal cells. In each case, the cells will be autologous, specifically being derived from the subject's own bone marrow.
7,283 studies on the registry are indexed under Stroke; 2,013 are open to participants now.
Browse Stroke studies →University of California, Irvine is the lead sponsor of 466 studies on the registry; 96 are open to participants now.
Of its 41 completed or terminated interventional studies of FDA-regulated products, 30 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Placebo
Drug: placebo
a single intravenous autologous bone marrow mononuclear cell transfusion
Biological: autologous bone marrow mononuclear cell transfusion
a single intravenous autologous marrow stromal cell transfusion
Biological: marrow stromal cells
a single intravenous transfusion approximately 2 days after bone marrow aspiration, and 4 days after stroke onset; the full amount of autologous mononuclear cells derived from 30 cc of bone marrow
Also known as: mononuclear cells
a single intravenous transfusion approximately 21 days after bone marrow aspiration, and 23 days after stroke onset; the full amount of marrow stromal cells cultured over 21 days from 30 cc of bone marrow (expected to be approximately 1,000,000 cells/kg body weight)
Also known as: mesenchymal stromal cells
a single intravenous transfusion of saline, approximately 2-21 days after bone marrow aspiration, and 4-23 days after stroke onset; the full amount of mononuclear cells derived from 30 cc of bone marrow
death
Time frame: 90 days after stroke onset
myocardial infarction
Time frame: 90 days after stroke onset
pulmonary embolism
Time frame: 90 days after stroke onset
ischemic stroke
Time frame: 90 days after stroke onset
deep venous thrombosis
Time frame: 90 days after stroke onset
other arterial or venous thrombosis
Time frame: 90 days after stroke onset
Infection requiring IV antibiotics
Time frame: 90 days after stroke onset
This study is withdrawn, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of California, Irvine