Safety of Autologous Human Umbilical Cord Blood in the Treatment of Stroke in Children.
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Functional outcome measure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Weeks 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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,
- •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.
结局指标
主要结局
Functional outcome measure
时间窗: Two years
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.
次要结局
- Speech Therapy Specific Neuropsychological outcome measures(Two years)
研究者
Aryn Knight
AVP Research
Memorial Hermann Health System