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Umbilical Cord Blood in the Treatment of Stroke in Children. (Pedi Stroke)

Primary Purpose

Arterial Ischemic Stroke (AIS) in Children

Status

Withdrawn

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Autologous Human Cord Blood derived Stem Cell injection

About this trial

This is an interventional treatment trial for Arterial Ischemic Stroke (AIS) in Children focused on measuring Autologous, Cord Blood, Stem Cells, Pediatric stroke, Children with ischemic stroke, Cerebral Palsy, Perinatal AIS

Eligibility Criteria

6 Weeks - 6 Years (Child)All SexesDoes not accept 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 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)

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 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:
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, Hepatitis B, Hepatitis C.
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, 1 year, and 2 year follow-up visits.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Biologic; Cord Blood Stem Cells; Intravenous injection

Arm Description

Autologous Human Umbilical Cord Blood derived Stem Cell injection

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Speech Therapy Specific Neuropsychological outcome measures

Age appropriate Neurologic examinations and speech therapy specific standardized testing will be performed pre-treatment and at all follow-up visits.

Full Information

NCT ID

NCT01700166

First Posted

October 2, 2012

Last Updated

January 21, 2014

Sponsor

James E.Baumgartner, MD

Collaborators

The Institute for Rehabilitaion and Research Foundation, Cord Blood Registry, Inc., The University of Texas Health Science Center, Houston, M.D. Anderson Cancer Center - Houston, Baylor College of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT01700166

Brief Title

Umbilical Cord Blood in the Treatment of Stroke in Children.

Acronym

Pedi Stroke

Official Title

Safety of Autologous Human Umbilical Cord Blood in the Treatment of Stroke in Children.

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Withdrawn

Why Stopped

Principal Investigator relocated; Study may resume in Fl Hosp. for Children, Orlando FL

Study Start Date

September 2012 (undefined)

Primary Completion Date

August 2013 (Actual)

Study Completion Date

December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

James E.Baumgartner, MD

Collaborators

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The specific aims of this study are: To determine if Human Umbilical Cord Blood (hUCB) infusion is safe in children with perinatal arterial ischemic stroke (AIS). To determine if late functional outcome, physiologic response, and anatomic findings are changed following hUCB infusion in children with perinatal AIS.

Detailed Description

This study will enroll ten pediatric patients who have their umbilical cord blood banked with Cord Blood Registry, Inc. (CBR), who have been diagnosed with an arterial ischemic stroke (AIS), and whose caregivers contacted CBR, Inc. to notify them that the child has experienced an AIS around the time of birth. After receiving permission to release the patient's contact information, the CBR team will then relay the contact information to the Stem Cell Study Group at the University of Texas - Houston (UT) / Children's Memorial Hermann Hospital (CMHH) who will contact the family, explain the study, and send a consent form for their review. Several weeks prior to the scheduled procedure date, the patient will go to their family doctor for a physical evaluation and have blood drawn to rule out problems with the child's health. After successfully meeting initial pre-screening criteria, the patient's family will make their own arrangements to travel to Houston for the study procedures. Once the patient is in Houston, he/she will undergo baseline assessments, including physical, neurological exams and tests, speech therapy testing, laboratory tests, and imaging (MRI) of the brain. If any of the blood tests are abnormal, or the patient has an active infection, the procedure may be postponed or the patient may possibly be excluded from the study. If the patient continues to meet all criteria, the frozen cord blood will be shipped overnight to a special lab in Houston, TX for processing. Once release criteria have been met, the cells will be brought to the CMHH for infusion into the patient's vein. The patient will remain at CHMM for 24 hours of monitoring, after which they will be allowed to go home. Patients will be called daily by the research staff through Day 14, and once a month after that. Patients will return to Houston, Texas for 6 month, 1 year and 2 year follow-up visits for repeat assessments, tests, and exams just like at the baseline visit. The MRI of the brain will only be repeated at the 6 month visit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Arterial Ischemic Stroke (AIS) in Children

Keywords

Autologous, Cord Blood, Stem Cells, Pediatric stroke, Children with ischemic stroke, Cerebral Palsy, Perinatal AIS

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Biologic; Cord Blood Stem Cells; Intravenous injection

Arm Type

Experimental

Arm Description

Autologous Human Umbilical Cord Blood derived Stem Cell injection

Intervention Type

Biological

Intervention Name(s)

Autologous Human Cord Blood derived Stem Cell injection

Other Intervention Name(s)

Patient's own cord blood, Patient's own stem cells

Intervention Description

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

Primary Outcome Measure Information:

Title

Functional outcome measure

Description

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.

Time Frame

Two years

Secondary Outcome Measure Information:

Title

Speech Therapy Specific Neuropsychological outcome measures

Description

Age appropriate Neurologic examinations and speech therapy specific standardized testing will be performed pre-treatment and at all follow-up visits.

Time Frame

Two years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Weeks

Maximum Age & Unit of Time

6 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 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) 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 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. 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, 1 year, and 2 year follow-up visits.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Timothy C. Foster, MD

Organizational Affiliation

The University of Texas Health Science Center, Houston

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

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

Organizational Affiliation

Florida Hospital for Children - Orlando

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

James E. Baumgartner, MD

Organizational Affiliation

Florida Hospital for Children - Orlando

Official's Role

Study Chair

Facility Information:

Facility Name

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

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

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Umbilical Cord Blood in the Treatment of Stroke in Children.

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