Pediatric Autologous Bone Marrow Mononuclear Cells for Severe Traumatic

Status Completed

Clinical Trial Summary

Pediatric severe traumatic brain injury (TBI) is the leading cause of death and disability in children ages 1-14 years old. There are no effective therapies to treat secondary brain injury and the post-injury response of CNS apoptosis and neuroinflammation. This study is a follow-up trial from a previously performed Phase I trial that demonstrated the safety and potential CNS structural preservation effect of intravenous autologous bone marrow mononuclear cells (BMMNC) after severe TBI in children. (Cox, 2011) The study is designed as a prospective, randomized, placebo controlled, blinded Phase 2 safety/biological activity study. The investigators hope to determine the effect of intravenous infusion of autologous BMMNCs on brain structure and neurocognitive/functional outcomes after severe TBI in children.

Clinical Trial Description

Study Design: Multicenter, randomized, blinded, placebo controlled, Bayesian adaptive dose escalation design. Study Intervention: Single dose administered within 48 hours from time of injury. Controls will undergo a sham harvest and receive similarly labeled/external appearance and volume of 0.9% NaCl. BMMNC's will be harvested and undergo processing under cGMP conditions to obtain 6x10^6 cells/kg or 10x10^6 cells/kg weight. The cellular product/placebo will be infused within 48 hours of injury. Safety Monitoring & Follow-Up: Subjects will be monitored for infusion related toxicity post-infusion through hospital discharge and follow-up return study visits. Laboratory and imaging studies will be repeated at the 1, 6, and 12-month follow-up visits. A medical safety monitor (MSM) will review blinded SAE reports following post-infusion Day 14 for each subject in real time to ensure good clinical practice and to quickly identify safety concerns. The MSM will remain blinded to the treatment assignment, unless the NINDS appointed DSMB approves unblinding. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01851083
Study type	Interventional
Source	The University of Texas Health Science Center, Houston
Contact
Status	Completed
Phase	Phase 2
Start date	August 2013
Completion date	October 12, 2020

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT03052712` - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies	N/A
Recruiting	`NCT05503316` - The Roll of Balance Confidence in Gait Rehabilitation in Persons With a Lesion of the Central Nervous System	N/A
Completed	`NCT04356963` - Adjunct VR Pain Management in Acute Brain Injury	N/A
Completed	`NCT03418129` - Neuromodulatory Treatments for Pain Management in TBI	N/A
Terminated	`NCT03698747` - Myelin Imaging in Concussed High School Football Players
Recruiting	`NCT05130658` - Study to Improve Ambulation in Individuals With TBI Using Virtual Reality -Based Treadmill Training	N/A
Recruiting	`NCT04560946` - Personalized, Augmented Cognitive Training (PACT) for Service Members and Veterans With a History of TBI	N/A
Completed	`NCT05160194` - Gaining Real-Life Skills Over the Web	N/A
Recruiting	`NCT02059941` - Managing Severe Traumatic Brain Injury (TBI) Without Intracranial Pressure Monitoring (ICP) Monitoring Guidelines	N/A
Recruiting	`NCT03940443` - Differences in Mortality and Morbidity in Patients Suffering a Time-critical Condition Between GEMS and HEMS
Recruiting	`NCT03937947` - Traumatic Brain Injury Associated Radiological DVT Incidence and Significance Study
Completed	`NCT04465019` - Exoskeleton Rehabilitation on TBI
Recruiting	`NCT04530955` - Transitioning to a Valve-Gated Intrathecal Drug Delivery System (IDDS)	N/A
Recruiting	`NCT03899532` - Remote Ischemic Conditioning in Traumatic Brain Injury	N/A
Suspended	`NCT04244058` - Changes in Glutamatergic Neurotransmission of Severe TBI Patients	Early Phase 1
Completed	`NCT03307070` - Adapted Cognitive Behavioral Treatment for Depression in Patients With Moderate to Severe Traumatic Brain Injury	N/A
Recruiting	`NCT04274777` - The Relationship Between Lipid Peroxidation Products From Traumatic Brain Injury and Secondary Coagulation Disorders
Withdrawn	`NCT04199130` - Cognitive Rehabilitation and Brain Activity of Attention-Control Impairment in TBI	N/A
Withdrawn	`NCT05062148` - Fundamental and Applied Concussion Recovery Modality Research and Development: Applications for the Enhanced Recovery	N/A
Withdrawn	`NCT03626727` - Evaluation of the Efficacy of Sodium Oxybate (Xyrem®) in Treatment of Post-traumatic Narcolepsy and Post-traumatic Hypersomnia	Early Phase 1

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Pediatric Autologous Bone Marrow Mononuclear Cells for Severe Traumatic Brain Injury

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms