NCT01700166

Brief Summary

The specific aims of this study are:

  1. 1.To determine if Human Umbilical Cord Blood (hUCB) infusion is safe in children with perinatal arterial ischemic stroke (AIS).
  2. 2.To determine if late functional outcome, physiologic response, and anatomic findings are changed following hUCB infusion in children with perinatal AIS.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2012

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 2, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 4, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 20, 2024

Status Verified

March 1, 2024

Enrollment Period

11 months

First QC Date

October 2, 2012

Last Update Submit

March 18, 2024

Conditions

Arterial Ischemic Stroke (AIS) in Children

Keywords

AutologousCord BloodStem CellsPediatric strokeChildren with ischemic strokeCerebral PalsyPerinatal AIS

Outcome Measures

Primary Outcomes (1)

  • Functional outcome measure

    Physiological (e.g., SSEP, EEG) and anatomic outcome (MRI) changes will be evaluated by repeating assessments, clinical tests and imaging exams at the pre-treatment and follow-up visits.

    Two years

Secondary Outcomes (1)

  • Speech Therapy Specific Neuropsychological outcome measures

    Two years

Study Arms (1)

Biologic; Cord Blood Stem Cells; Intravenous injection

EXPERIMENTAL

Autologous Human Umbilical Cord Blood derived Stem Cell injection

Biological: Autologous Human Cord Blood derived Stem Cell injection

Interventions

Autologous Human Cord Blood derived Stem Cell injectionBIOLOGICAL

One time intravenous (in the vein) injection with two year follow-up

Also known as: Patient's own cord blood, Patient's own stem cells
Biologic; Cord Blood Stem Cells; Intravenous injection

Eligibility Criteria

Age6 Weeks - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Between 6 weeks and 6 years of age on the day of study cord blood infusion.
  • MRI documented single arterial distribution infarction.
  • Initial injury occurring in the pre-natal or perinatal period.
  • Ability of caregivers to understand and speak English
  • Ability of child and caregiver to travel to Houston, and stay for at least 4 days, and to return for all Follow-up visits (patient is responsible for cost of travel and lodging while in Houston)

You may not qualify if:

  • Inability to obtain all pertinent medical records, including pertinent physician notes, laboratory findings, and radiographic images, related to the original injury, hospitalization and rehabilitation - must be sent to research team at least 14 days prior to scheduled study cord blood treatment.
  • Recent radiographic evidence (imaging performed within past 2 weeks) of extensive stroke as evidenced by \>100ml lesion.
  • Multifocal infarctions on screening MRI.
  • Evidence of hypoxic-ischemic encephalopathy on screening MRI.
  • Uncorrected coagulopathy during the baseline period defined as INR \> 1.4; PTT\> 35 sec; PLT \< 100,000.
  • Known history of:
  • Recently diagnosed infection (within past 2 weeks) requiring treatment and/or medical intervention.
  • Renal disease or altered renal function as defined by serum creatinine \> 1.5 mg/dL at admission.
  • Hepatic disease or altered liver function as defined by SGPT \> 150 U/L, and/or T. Bilirubin \>1.3 mg/dL at enrollment.
  • Malignancy.
  • Immunosuppression as defined by WBC \< 3 (10x3) at admission.
  • HIV, Hepatitis B, Hepatitis C.
  • Pneumonia, or chronic lung disease requiring oxygen.
  • Cord blood sample contamination.
  • Participation in a concurrent intervention study.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Memorial Hermann Hospital; University of Texas Health Science Center - Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Ischemic StrokeCerebral Palsy

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBrain Damage, Chronic

Study Officials

  • Timothy C. Foster, MD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

  • Linda S. Baumgartner, MS, CCC-SLP, LSLS, Cert.AVT

    Florida Hospital for Children - Orlando

    PRINCIPAL INVESTIGATOR

  • James E. Baumgartner, MD

    Florida Hospital for Children - Orlando

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
AVP Research

Study Record Dates

First Submitted

October 2, 2012

First Posted

October 4, 2012

Study Start

September 1, 2012

Primary Completion

August 1, 2013

Study Completion

December 1, 2016

Last Updated

March 20, 2024

Record last verified: 2024-03

Locations

US(1)