Umbilical Cord Blood in the Treatment of Stroke in Children.

NCT ID: NCT01700166

Last Updated: 2024-03-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2016-12-31

Brief Summary

The specific aims of this study are:

1. To determine if Human Umbilical Cord Blood (hUCB) infusion is safe in children with perinatal arterial ischemic stroke (AIS).

2. 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.

Conditions

Arterial Ischemic Stroke (AIS) in Children

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Biologic; Cord Blood Stem Cells; Intravenous injection

Autologous Human Umbilical Cord Blood derived Stem Cell injection

Group Type: EXPERIMENTAL

Autologous Human Cord Blood derived Stem Cell injection

Intervention Type: BIOLOGICAL

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

Interventions

Autologous Human Cord Blood derived Stem Cell injection

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

Intervention Type: BIOLOGICAL

Other Intervention Names

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

Eligibility Criteria

Inclusion Criteria

1. Between 6 weeks and 6 years of age on the day of study cord blood infusion.

2. MRI documented single arterial distribution infarction.

3. Initial injury occurring in the pre-natal or perinatal period.

4. Ability of caregivers to understand and speak English

5. 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.

1. Recent radiographic evidence (imaging performed within past 2 weeks) of extensive stroke as evidenced by >100ml lesion.

2. Multifocal infarctions on screening MRI.

3. Evidence of hypoxic-ischemic encephalopathy on screening MRI.

4. Uncorrected coagulopathy during the baseline period defined as INR > 1.4; PTT> 35 sec; PLT < 100,000.

5. 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.

6. Pneumonia, or chronic lung disease requiring oxygen.

7. Cord blood sample contamination.

8. Participation in a concurrent intervention study.

9. Desire for organ-donation in the event of death.

10. 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.

• Minimum Eligible Age: 6 Weeks
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Institute for Rehabilitaion and Research Foundation

OTHER

Sponsor Role: collaborator

Cord Blood Registry, Inc.

INDUSTRY

Sponsor Role: collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: collaborator

M.D. Anderson Cancer Center - Houston

UNKNOWN

Sponsor Role: collaborator

Baylor College of Medicine

OTHER

Sponsor Role: collaborator

Aryn Knight

OTHER

Sponsor Role: lead

Responsible Party

Aryn Knight

AVP Research

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Timothy C. Foster, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

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

Role: PRINCIPAL_INVESTIGATOR

Florida Hospital for Children - Orlando

James E. Baumgartner, MD

Role: STUDY_CHAIR

Florida Hospital for Children - Orlando

Locations

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

Houston, Texas, United States

Countries

United States

Other Identifiers

JB IND #14576

Identifier Type: -

Identifier Source: org_study_id