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Study Summary
No. 2005-0937:.......Other Supportive......Laura L. Worth......Pediatrics
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Study Summary Title
Study Summary
Number:		2005-0937
Study Title:Research Protocol: Safety of Autologous Stem Cell Treatment for Traumatic Brain Injury in Children
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Physician New Patient Referral
Name:Laura L. WorthPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:PediatricsReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-563-5404
Contact us about clinical trials
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General Information
Disease Group:Other SupportiveSupported By:N/A
Phase of Study:Phase IReturn
Visit:		N/A
Treatment
Agents:		CD34Home Care:N/A
Treatment Loc:Independent Multicenter Arrangements
Estimated
Length of Stay
in Houston:		Patients will not be admitted at M D Anderson Cancer Center. All admissions
will be at Memorial Hermann Children's Hospital. Minimal hospital stay 21
days.
Description/
Intervention:		Unavailable
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Study Objectives / Outcomes
Primary Objectives:
1. To determine if bone marrow progenitor cell harvest and i.v. transplantation is safe in children after traumatic brain injury.
2. To determine if late functional outcome is improves with stem cell transplantation compared to institutional, age, and severity of matched historical controls
Secondary Objective:
To accomplish in vitro bone marrow progenitor cell labeling using magnetodendrrimers. In vitro cell labeling with magnetodendrimers will be studied with in vitro magnetic resonance imaging to test labeling efficiency for future studies.
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Study Status Information
Study Activation / Registration Date:04/10/2007
IRB Review and Approval Date:04/10/2007
Study Type:Phase I
Recruitment Status:Terminated
Projected Accrual:10
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
Inclusion Criteria:1) Ages 5 - 14 years on day of injury

2) Hospital admission Glasgow Coma Sore bewteen 5 and 8.

3) Initial injury occurring less than 24 hours prior to consent

4) Ability of child and caregiver to speak English
Exclusion Criteria:1) Known history of previous brain injury

2) Known history of developmental delay.

3) Previous neurological imapirment and/or deficit

4) Known history of seizure disorder requiring anti-convulsant therapy

5) Recently treated infection

6) Renal disease as defined as serum creatinine >1.5 mg/dL at admission.

7) Hepatic disease or altered liver function as defined by SGPT. 150 U/L and/or bilirubin > 1.3 mg/dL at admission.

8) Known history of cancer.

9) Immunosuppression as defined by WBC <3 (10x3) at admission.

10) Known history of HIV.

11) Obliteration of perimesencephalic cistern on initial head CT/MRI suggesting prolonged hypoxic ischemic insult.

12) Initial hospital intercranial pressure (ICP) >40.

13) Hemodynamic instability at the time of consent as defined as ongoing fluid resuscitation and/or requirement for inotropic support to maintain MAP at or above normals for age - does not include CPP based inotropic support.

14) Uncorrected coagulopathy at the time of consent as defined as INR >1.4; PTT . 36 sec; PLT < 100,000; Fibrinogen < 100 g/dL.

15) Unstable pelvic fractures defined as requiring operative fixation to manage.

16) Pulmonary contusions defined as a chest x-ray with non-anatomic opacification and/or PaO2:FIO2 ratio ,250 associated with the mechanism or injury

17) Solid or hollow visceral injury of the abdomen and/or pelvis as diagnosed by CT or other imaging.

18) Spinal cord injury as diagnosed by CT or MR imaging or by clinical findings.

19) Persistent hypoxia defined as Sa)2 <94% for 30 min occurring at any time from hospital admission to time of consent.

20) Positive urine pregnancy test.

21) Participation in an intervention study.

22) Unwillingness to return for follow-up visits.
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Links
Registration Number: NCT00254722
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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