Cord Blood Infusion for Ischemic Stroke

Completed · Phase 1

Conditions studied: Stroke

In brief

This is a phase one study investigating the safety of a single, intravenous infusion of banked allogeneic umbilical cord blood in subjects following an acute ischemic stroke. The cord blood infusion must be given within 3-10 days of the stroke. Follow up phone calls will occur at 1, 6, and 12 months post-infusion, and will include telephone surveys on post-stroke rehabilitation and functioning. A follow up clinic visit at 90 days will include a neurological exam, MRI, and blood tests.

Key facts

Study ID

NCT02397018

Run by

Joanne Kurtzberg, MD

People needed

10

Starts

2015-05-01

Expected to finish

2017-02-23

Last updated by the study team

2019-10-17

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• An individual is eligible for inclusion if all of the following apply:
• Is 18-80 years old
• Has had a recent (within the past 9 days), acute, cortical, hemispheric, ischemic stroke in the middle cerebral artery (MCA) distribution without a midline shift as detected by magnetic resonance imaging (MRI) as a diffusion-weighted image (DWI) abnormality
• Has a National Institutes of Health Stroke Scale (NIHSS) score of 8-15 (R) and 8-18 (L) at the time of enrollment with no more than a 4 point increase (worsening of score) from the baseline score compared to 24 hours prior to infusion
• Subjects must have a platelet count >100,000/uL, hemoglobin >8gm/dl, and white blood cell count (wbc) >2,500/uL.
• Subjects who received tissue plasminogen activator (tPA) or underwent mechanical reperfusion may be included in the study.
• Is able to provide consent to study or consent is obtained from the subject's legally authorized representative
• Subjects of childbearing potential must practice effective contraception during the study, and be willing to continue contraception for at least 6 months after intervention so that, in the opinion of the investigator, they will not become pregnant during the course of the study
• Is a good candidate for the trial, in the opinion of the investigator
• Agrees to participate in follow up visits
• Has an ABO/Rh matched umbilical cord blood unit with a minimum of 0.5 x 10\^7 total nucleated cells (TNCC)/kg based on the pre-cryopreservation TNCC.

You may not qualify if…

• An individual is ineligible to participate if any of the following apply.
• Medical Conditions:
• Has a medical history of neurological or orthopedic pathology with a deficit as a consequence that results in a modified Rankin Scale >1 before stroke or has a pre-existing cognitive deficit
• Has clinically significant and/or symptomatic hemorrhage associated with stroke
• Has new intracranial hemorrhage, edema, or mass effect that may place patient at increased risk for secondary deterioration when assessed prior to infusion
• Has hypotension as defined as the need for IV pressor support of systolic blood pressure <90
• Has isolated brain stem stroke
• Has pure lacunar stroke
• Requires mechanical ventilation
• Requires a craniotomy
• Has a serious psychiatric or neurological disease which could alter evaluation on functional or cognitive scales
• Has an active systemic infection or is HIV positive
• Has had an active malignancy within 3 years prior to the start of screening excluding skin cancers other than melanoma
• Has known coagulopathy such as Factor V Leyden, AntiPhospholipid Syndrome (APC), Protein C, Protein S deficiency, sickle cell, anticardiolipin antibody, or phospholipid syndrome
• Has any concurrent illness or condition that in the opinion of the investigator might interfere with treatment or evaluation of safety
• Has current or recent history of alcohol or drug abuse, or stroke associated with drug abuse
• Pregnant as documented by urine or blood test
• Concomitant or Prior Therapies:
• Subjects currently receiving immunosuppressant drugs
• History of prior transfusion reaction
• Currently on dialysis
• Recipient of bone marrow or organ transplant
• Renal insufficiency with serum creatinine >2.0 mg/dL
• Hepatic insufficiency (bilirubin >2.5mg/dL or transaminases >5x the upper limit of normal). Patients with Gilberts syndrome are eligible for study enrollment if other liver function tests are normal, regardless of bilirubin level.
• Any previous or current treatment with angiogenic growth factors, cytokines, gene or stem cell therapy

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States
• Houston Methodist — Houston, Texas, United States

Full record on ClinicalTrials.gov

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