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

Withdrawn before enrolling · Phase 1/Phase 2

Conditions studied: Perinatal Arterial Ischemic Stroke

In brief

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.

Key facts

Study ID

NCT02460484

Run by

James Baumgartner, MD

People needed

0

Starts

2015-04-01

Expected to finish

2022-06-01

Last updated by the study team

2026-06-16

Who can join

Age: 0 and older, up to 6. Sex: any. Healthy volunteers: not accepted.

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 prenatal or perinatal period
• Ability of child and caregiver to travel to Orlando, 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 Orlando)

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 FHFC research team 14 days prior to scheduled study cord blood treatment. Need brain MRI with flair sequence <2 weeks old.
• 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
• Any evidence of active maternal infection during the pregnancy (Hepatitis A, Hepatitis B, Hepatitis C, HIV 1, HIV 2, Human T-lymphotropic Virus (HTLV) 1, HTLV 2
• Pneumonia, or chronic lung disease requiring oxygen
• Cord blood sample contamination
• Participation in a concurrent intervention study
• Desire for organ-donation in the event of death
• Unwillingness or inability to stay for at least four days following cord blood infusion (should any problems arise following the infusion) and to return for 6 month, and 1 year follow-up visits

Where it is running

• Florida Hospital for Children — Orlando, Florida, United States

Full record on ClinicalTrials.gov

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