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

James Baumgartner, MD

Status and phase

Suspended

Phase 2

Phase 1

Conditions

Perinatal Arterial Ischemic Stroke

Treatments

Biological: Autologous Cord Blood Infusion

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02460484

443002

Details and patient eligibility

About

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.

Full description

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.

Enrollment

10 estimated patients

Sex

All

Ages

6 weeks to 6 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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)

Exclusion criteria

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:
1. Recently diagnosed infection (within past 2 weeks) requiring treatment and/or medical intervention
2. Renal disease or altered renal function as defined by serum creatinine >1.5 mg/dL at admission
3. Hepatic disease or altered liver function as defined by SGPT > 150 U/L, and/or T. Bilirubin >1.3 mg/dL at enrollment
4. Malignancy
5. Immunosuppression as defined by WBC < 3 (10x3) at admission
6. 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