Clinical Trial: Safety of Autologous Human Umbilical Cord Blood Treatment for Perinatal Arterial Ischemic Stroke

Study Status: Suspended
Recruit Status: Suspended
Study Type: Interventional

Official Title: Safety of Autologous Human Umbilical Cord Blood Treatment for Perinatal

Brief Summary: Autologous human umbilical cord blood (hUCB) stored at Cord Blood Registry will be given to children who have suffered from a Perinatal Arterial Ischemic Stroke. The aim is to determine if hUCB infusion is safe, if late functional outcome is improved, if hUCB treatment improves physiologic response in the child's SSEP & EEG, and the effect of hUCB infusion in altering anatomic findings on MRI.

Detailed Summary:

Autologous human umbilical cord blood (hUCB) stored at Cord Blood Registry will be given to children who have suffered from a Perinatal Arterial Ischemic Stroke.

Subjects will come to Orlando for pretesting to include an MRI, SSEP, Urodynamics, blood work: CBC, CMP, Hepatic Function Panel, PT/PTT/INR, Chest Xray, EEG, Gross Motor Function Classification, Manual Ability Classification System, and a Speech and Language Evaluation.

After pretesting, the subjects will receive their autologous cord blood infusion intravenously. The subjects will then be monitored for 24 hours post infusion. After 24 hours, the subject will undergo repeat blood work and a chest x ray. Subjects will then be discharged home.

Subjects will follow up in Orlando at 6 months and 1 year post infusion. Follow up testing will repeat the exams performed at pretesting.


Sponsor: Florida Hospital

Current Primary Outcome:

  • Composite Outcome: Hemodynamic Safety [ Time Frame: 1 year ]

    Three primary and two secondary hemodynamic indices will be monitored as indices of hemodynamic stability throughout the infusion and post-infusion periods. Heart rate, blood pressure, and oxygen saturation will be recorded every 5 minutes during the infusion, every 30 minutes for 2 hours after infusion and then hourly for 6 hours. A consistent, non-isolated 20% decrease in any of these indices will be prompt additional maneuvers to restore MAP.

    Two secondary hemodynamic indices will be monitored as indices of hemodynamic stability: capillary refill and heart rate. Prolongation of capillary refill by 2 seconds from baseline and/or >20% change in heart rate during the procedure will prompt an evaluation as to the etiology of the change in hemodynamic status. An adverse event will be defined as a sustained (> 10 minutes) >20% decrease in MAP. Transient decreases in MAP that respond to fluid infusion or inotropes will not be considered adverse events.

  • Composite Outcome: Pulmonary Safety [ Time Frame: 1 year ]
    A concern exists regarding the systemic infusion of leukocytes in a concentrated manner. Theoretically, activated monocytes could function to enhance PMN migration into the lung, as the lung is the primary "first pass" filter for intravenous infusion of any cellular product. PMN mediated organ injury typically occurs over a 6-24 hour time frame. Based on this, Chest radiographs will be performed and evaluated at Baseline and on Post-Infusion Day 1. Chest radiographs will be evaluated for systemic infusion of leukocytes in a concentrated manner. Addit

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • EEG [ Time Frame: 1 year ]
      History including current seizure frequency and anticonvulsant regimen. Comparison of current EEG findings to prior studies.
    • Fine and Gross Motor [ Time Frame: 1 year ]
      History and physical exam findings compared to previous evaluation. SSEP testing compared to prior tests. MACS and GMFCS classification compared to prior evaluations.
    • Language [ Time Frame: 1 year ]
      Language will be evaluated before treatment and at follow-up visits 6 months and 1 year. Full evaluations will include measures of language expression, reception, and oral-motor functioning. Formal tests include: The Preschool Language Scale, Fifth Edition (PLS-5), Expressive Vocabulary Test, Second Edition (EVT-2), and Peabody Picture Vocabulary Test, Fourth Edition (PPVT-4). Informal measures include: phonetic inventory, oral motor evaluation and The Rossetti Infant-Toddler Language Scale.
    • Speech [ Time Frame: 1 year ]
      Speech will be evaluated before treatment and at follow-up visits 6 months and 1 year. Full evaluations will include measures of speech production. Formal tests include: The Comprehensive Assessment of Spoken Language (CASL) and The Arizona Articulation Proficiency Scale- Third Edition.
    • Bladder: Urodynamics [ Time Frame: 1 year ]
      Questions focusing on toilet training and continence will be included in the patient's history. CMG testing will also be performed, and compared to prior CMG tests.


    Original Secondary Outcome:

    • EEG [ Time Frame: 1 year ]
      History including current seizure frequency and anticonvulsant regimen. Comparison of current EEG findings to prior studies.
    • Fine and Gross Motor [ Time Frame: 1 year ]
      History and physical exam findings compared to previous evaluation. SSEP testing compared to prior tests. MACS and GMFCS classification compared to prior evaluations.
    • Speech and Language [ Time Frame: 1 year ]
      Speech and language will be evaluated before treatment and at follow-up visits 6 months and 1 year. Full evaluations will include measures of language expression, reception, speech production and oral-motor functioning. Formal tests include: The Preschool Language Scale, Fifth Edition (PLS-5), the Comprehensive Assessment of Spoken Language (CASL), Expressive Vocabulary Test, Second Edition (EVT-2), Peabody Picture Vocabulary Test, Fourth Edition (PPVT-4), The Arizona Articulation Proficiency Scale- Third Edition, Informal measures include: phonetic inventory, oral motor evaluation and The Rossetti Infant-Toddler Language Scale.
    • Bladder: Urodynamics [ Time Frame: 1 year ]
      Questions focusing on toilet training and continence will be included in the patient's history. CMG testing will also be performed, and compared to prior CMG tests.


    Information By: Florida Hospital

    Dates:
    Date Received: April 23, 2015
    Date Started: April 2015
    Date Completion: June 2019
    Last Updated: August 23, 2016
    Last Verified: August 2016