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Phase 2 Pediatric Autologous BMMNC for Severe TBI



See All Traumatic Brain Injury Trials

The National Institute of Neurological Disorders and Stroke, part of the National Institutes of Health, is looking for individuals to participate in clinical studies.  Participating in clinical trials allows you to play an active role in research on the nature and causes of many disorders of the brain and nervous system, and to possibly help physician-scientists develop future treatments.  The information below is designed to help you quickly learn about actively recruiting research studies for which you or someone you know may be eligible.

Description:

The purpose of this study is to determine if bone marrow mononuclear (or white blood) cells (BMMNCs) can improve brain structure and neurocognitive or functional outcomes in children with severe traumatic brain injury (TBI). BMMNCs are made up of a mixture of cells, including stem cells. Stem cells are cells that have the potential to develop into some or many different cell types in the body.

Severe pediatric TBI is the leading cause of death and disability in children ages 1 to 14 years old.  Children who survive severe TBI usually have problems with memory and coordination that interfere with school and social interactions.  Currently there are no treatments to repair the brain after a severe TBI or to correct the memory or coordination problems that typically follow severe TBI.

Fifty children, ages 5 to 15 years old, will be enrolled over 5 years in this prospective, randomized study.  In addition to standard TBI management and treatment, each participant will have 1 of 2 procedures:  a bone marrow harvest and infusion of his/her own BMMNC, or a placebo or “sham” harvest and infusion of normal saline. Participants also will undergo a spleen ultrasound, magnetic resonance imaging (MRI), and blood and cerebrospinal fluid collections.

Follow-up will occur at 1-month, 6-month, and 1-year post TBI.  During each follow-up session, participants will undergo physical and neurological exams, laboratory tests, blood collection, a spleen ultrasound, a chest x-ray, and neuropsychological testing.

Knowledge gained from this study may provide scientists with information on how to better treat TBI in children.

Eligibility Criteria:

Please follow this link for trial eligibility information to share with your doctor.

Study Design: 

Interventional

Study Locations: 

Houston, Texas

For more information:

Contact: Steven C Kosmach, MSN, RN, CCRC; Tel: 713-500-7329, email: steven.kosmach@uth.tmc.edu; or Fernando Jimenez, MS, RN; Tel: 713-500-7395; email: fernando.jimenz@uth.tmc.edu; or visit: http://clinicaltrials.gov/ct2/show/NCT01851083

Last Reviewed July 22, 2014