Traumatic Brain InjuryPhase 1/2NCT01251003
Safety Study of Umbilical Cord Blood To Treat Pediatric Traumatic Brain Injury
A Phase 1/2 study testing Autologous cord blood in people with Traumatic Brain Injury, run by Charles Cox at 1 site in United States.
Trial summary
The purpose of this study is to determine if it is safe to use stored autologous Human Umbilical Cord Blood (hUCB) to treat pediatric patients that sustain a severe or moderate Traumatic Brain Injury (TBI), and have not fully recovered as measured by the Glasgow Outcome Score-Expanded (GOS-EC)/Child at 6 to 18 months… Read more about this study
- Who is it for?
- Ages 18 months to 17 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Autologous cord blood
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to May 2015
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Hospital admission Glasgow Coma Score between 3 and 12 at the time of injury
- Injury occurring 6 to 18 months prior to study cord blood infusion (+/- 30 days)
- Ability of child and caregiver to travel to Houston, and stay for at least 4 days, and to return for all Follow-up visits
- Ability of child to understand (and speak) English
- Child's own cord blood banked at Cord Blood Registry
Who cannot join
- Inability to obtain all pertinent medical records, including pertinent physician notes, laboratory findings, and radiographic images, related to the original injury, hospitalization and rehabilitation
- Recent radiographic evidence of extensive stroke as evidenced by >100ml lesion
- Pre-injury history of seizure disorder and/or neurological impairment
- Obliteration of perimesencephalic cistern on initial head CT/MRI
- Initial hospital Intracranial Pressure (ICP) > 40
- Unhealed fractures or wounds including osteomyelitis
Show all 10Show fewer
- Pneumonia, or chronic lung disease requiring oxygen
- Spinal cord injury as diagnosed by CT or MR imaging or by clinical findings
- Cord blood sample contamination
- Participation in a concurrent intervention study
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Medical School at Houston, Children's Memorial Hermann Hospital
Houston, Texas, 77030
About this study
Official title: Safety of Autologous Human Umbilical Cord Blood Treatment for Traumatic Brain in Children
The purpose of this study is to determine if it is safe to use stored autologous Human Umbilical Cord Blood (hUCB) to treat pediatric patients that sustain a severe or moderate Traumatic Brain Injury (TBI), and have not fully recovered as measured by the Glasgow Outcome Score-Expanded (GOS-EC)/Child at 6 to 18 months post-injury.
Read the detailed description
Traumatic brain injury is the primary cause of pediatric trauma related morbidity and mortality. Currently there is no reparative therapeutic option available, and all interventions are designed to prevent injury progression or secondary brain injury. Pre-clinical data suggest that progenitor cellular infusions may reduce the severity of injury by a number of proposed mechanisms. The current study proposes a Phase 1 Safety Trial using stored autologous UCB to treat patients that sustain a severe or moderate TBI, and have not fully recovered as measured by the Glasgow Outcome Score-Expanded/Child at 6 to 18 months post-injury. We have chosen to use one bank that uses standardized processing and storage protocol to reduce cell product variability.
Families who have banked hUCB at Cord Blood Registry, Inc. (CBR), will be prospectively notified of the possibility of using their child's stored UCB if they sustain a moderate or severe TBI and have a persistent deficit at 6-18 months. Prior to enrolling in the study, patients will have their medical records, imaging studies reviewed, and a telephone interview will determine potential eligibility and exclusion criteria. If eligible, the patients will travel to Houston to undergo a medical history and physical exam, neuropsychiatric evaluation, DT-MRI imaging of the brain, and baseline laboratory evaluation. The UCB will be shipped to the Center for Cell and Gene Therapy for reanimation and characterization/determination of release criteria of the cell product (contamination-free). The UCB will be infused intravenously and the patient will be monitored as an in-patient in the Pediatric Intensive Care Unit (PICU) located within Children's Memorial Hermann Hospital for 24 hours, after which the patient will be discharged but will return the next day for a final examination. Follow-up visits will occur back at UT-Houston at 180 days, 1 year and 2 years post-infusion - these visits will include medical history and physical exam, neurological and neuropsych evaluations, and DT-MRI imaging of the brain.
- Conditions
- Traumatic Brain Injury
- Being tested
- Autologous cord blood
- Keywords
- Traumatic Brain Injury, TBI, Pediatric, Chronic
- Medical subject headings
- Brain Injuries, Traumatic, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous cord bloodBiological
there is no minimum acceptable dose, and the maximum allowable dose will be 10x10(9)cells/kg given IV (in the vein), one time infusion
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine if autologous hUCB transplantation is safe and free of infusion related toxicity.
Measured: 0-21 days post cellular product infusion
Secondary outcomes (1)
Determine if autologous hUCB transplantation improves post-TBI neuropsychological and imaging outcomes measures.
Measured: 6 months, 12 months, 24 months post cellular product infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2010 (estimated)
- Study startJan 2011
- Primary completionDec 2014 (estimated)
- Study completionMay 2015
Why it stopped: Unable to identify eligible subjects with traumatic brain injury who also have banked umbilical cord blood at CBR.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles Cox
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Charles Cox, The University of Texas Health Science Center, Houston
- Investigators
- Charles S Cox, Jr., MD, Principal investigator, University of Texas Medical School at Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01251003
- Sponsor's protocol ID
- HSC-MS-10-0061
- Status last verified
- Dec 2015
- First submitted
- 29 Nov 2010
- Last updated
- 10 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Autologous Human Umbilical Cord Blood Treatment for Traumatic Brain in Children
- ClinicalTrials.gov ID
- NCT01251003
- Acronym / sponsor ID
- HSC-MS-10-0061
- Conditions
- Traumatic Brain Injury
- Keywords
- Traumatic Brain Injury, TBI, Pediatric, Chronic
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to identify eligible subjects with traumatic brain injury who also have banked umbilical cord blood at CBR.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Charles CoxUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2014 (estimated)
- Study completion
- May 2015 (actual)
- First posted
- 1 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if it is safe to use stored autologous Human Umbilical Cord Blood (hUCB) to treat pediatric patients that sustain a severe or moderate Traumatic Brain Injury (TBI), and have not fully recovered as measured by the Glasgow Outcome Score-Expanded (GOS-EC)/Child at 6 to 18 months post-injury.
Detailed description
Traumatic brain injury is the primary cause of pediatric trauma related morbidity and mortality. Currently there is no reparative therapeutic option available, and all interventions are designed to prevent injury progression or secondary brain injury. Pre-clinical data suggest that progenitor cellular infusions may reduce the severity of injury by a number of proposed mechanisms. The current study proposes a Phase 1 Safety Trial using stored autologous UCB to treat patients that sustain a severe or moderate TBI, and have not fully recovered as measured by the Glasgow Outcome Score-Expanded/Child at 6 to 18 months post-injury. We have chosen to use one bank that uses standardized processing and storage protocol to reduce cell product variability.
Families who have banked hUCB at Cord Blood Registry, Inc. (CBR), will be prospectively notified of the possibility of using their child's stored UCB if they sustain a moderate or severe TBI and have a persistent deficit at 6-18 months. Prior to enrolling in the study, patients will have their medical records, imaging studies reviewed, and a telephone interview will determine potential eligibility and exclusion criteria. If eligible, the patients will travel to Houston to undergo a medical history and physical exam, neuropsychiatric evaluation, DT-MRI imaging of the brain, and baseline laboratory evaluation. The UCB will be shipped to the Center for Cell and Gene Therapy for reanimation and characterization/determination of release criteria of the cell product (contamination-free). The UCB will be infused intravenously and the patient will be monitored as an in-patient in the Pediatric Intensive Care Unit (PICU) located within Children's Memorial Hermann Hospital for 24 hours, after which the patient will be discharged but will return the next day for a final examination. Follow-up visits will occur back at UT-Houston at 180 days, 1 year and 2 years post-infusion - these visits will include medical history and physical exam, neurological and neuropsych evaluations, and DT-MRI imaging of the brain.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Hospital admission Glasgow Coma Score between 3 and 12 at the time of injury
- Injury occurring 6 to 18 months prior to study cord blood infusion (+/- 30 days)
- Ability of child and caregiver to travel to Houston, and stay for at least 4 days, and to return for all Follow-up visits
- Ability of child to understand (and speak) English
- Child's own cord blood banked at Cord Blood Registry
Key exclusion criteria (10 listed)
- Inability to obtain all pertinent medical records, including pertinent physician notes, laboratory findings, and radiographic images, related to the original injury, hospitalization and rehabilitation
- Recent radiographic evidence of extensive stroke as evidenced by >100ml lesion
- Pre-injury history of seizure disorder and/or neurological impairment
- Obliteration of perimesencephalic cistern on initial head CT/MRI
- Initial hospital Intracranial Pressure (ICP) > 40
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous cord bloodthere is no minimum acceptable dose, and the maximum allowable dose will be 10x10(9)cells/kg given IV (in the vein), one time infusion | Biological | – |
Primary outcome
Determine if autologous hUCB transplantation is safe and free of infusion related toxicity.
Time frame: 0-21 days post cellular product infusion
1 secondary outcome
Determine if autologous hUCB transplantation improves post-TBI neuropsychological and imaging outcomes measures.
Time frame: 6 months, 12 months, 24 months post cellular product infusion
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles S Cox, Jr., MD principal investigator
University of Texas Medical School at Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Autologous cord blood in people with Traumatic Brain Injury, run by Charles Cox at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine if autologous hUCB transplantation is safe and free of infusion related toxicity. (time frame: 0-21 days post cellular product infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2015.