Brain Injuries, TraumaticPhase 2NCT02525432
Autologous Stem Cell Study for Adult TBI (Phase 2b)
A Phase 2 study testing Autologous BMMNC Infusion in people with Brain Injuries, Traumatic and Brain Injuries, Acute, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to determine the effect of intravenous infusion of autologous bone marrow mononuclear cells (BMMNC) on brain structure and neurocognitive/functional outcomes after severe traumatic brain (TBI) injury in adults. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Brain Injuries, Traumatic, Brain Injuries, Acute, TBI (Traumatic Brain Injury)
- What is being tested?
- Autologous BMMNC Infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2016to Jan 2025
- Phase
- Phase 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults 18 to 55 years of age on the day of injury,
- Non-penetrating closed head trauma.
- Glasgow Coma Score between (GCS) between 3 and 8, (best un-medicated post-resuscitation score during screening).
- Ability to obtain legally authorized representative consent for participation and complete the BMMNC/Sham harvest and cell/placebo infusion within 48 hours of the initial injury.
- Ability to speak English or Spanish.
Who cannot join
- Known history of:
- previous brain injury,
- intellectual deficiency or psychiatric condition likely to invalidate our ability to assess post-injury changes in cognition or behavior,
- neurologic impairment and/or deficit,
- seizure disorder requiring anti-convulsant therapy,
- recently treated significant infection,
Show all 25Show fewer
- renal disease/altered renal function (post-resuscitation serum creatinine > 1.5 mg/dL),
- chronic hepatic disease or altered liver function (post-resuscitation SGPT > 150 U/L, and/or T. Bilirubin >1.3 mg/dL),
- cancer,
- Chemical or ETOH dependency,
- immunosuppression (admission WBC < 3X103),
- HIV positive status;
- Obliteration of perimesencephalic cistern on initial head CT/MRI suggesting prolonged hypoxic ischemic insult;
- Initial hospital ICP > 40 mm Hg;
- Hemodynamic instability at the time of screening defined as SBP < 90mmHg, 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;
- Uncorrectable coagulopathy at the time of screening;
- Unstable pelvic fractures that in the P.I.'s opinion would preclude the bone marrow / sham harvest;
- Pulmonary contusions defined as a chest x-ray with non-anatomic opacification and PaO2:FiO2 ratio < 250 associated with the mechanism of injury;
- Greater than AAST Grade III solid or hollow visceral injury of the abdomen and/or pelvis diagnosed by CT or other imaging;
- Spinal cord injury diagnosed by CT or MR imaging or by clinical findings;
- Persistent hypoxia defined as SaO2 < 94% for > 30 minutes occurring at any time from hospital admission to time of consent;
- Positive pregnancy test (if applicable);
- Concurrent participation in an interventional drug/device research study;
- Unwillingness to return for follow-up visits;
- Contraindications to MRI.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: A Multicenter Trial of Autologous Bone Marrow Mononuclear Cells for the Treatment of Adult Severe Traumatic Brain Injury
The purpose of this study is to determine the effect of intravenous infusion of autologous bone marrow mononuclear cells (BMMNC) on brain structure and neurocognitive/functional outcomes after severe traumatic brain (TBI) injury in adults. The primary objective is to determine if the intravenous infusion of autologous BMMNC after severe TBI results in structural preservation of global gray matter (GM) volume and white matter (WM) volume and integrity; as well as select regions of interest in the corpus callosum. THe secondary objectives are to determine if autologous BMMNC infusion improves functional and neurocognitive deficits in adults after TBI; reduces the neuroinflammatory response to TBI; evaluate spleen size and splenic blood flow over time using ultrasound and corresponding changes in inflammatory cytokines; and infusion related toxicity and long-term follow-up safety evaluations.
Read the detailed description
Traumatic brain injuries are associated with 33% of all trauma related deaths. There are no effective therapies to treat secondary brain injury and the post-injury response of CNS apoptosis and neuroinflammation. Pre-clinical and Phase I clinical progenitor cell therapies have shown promise in TBI/stroke via (1) promotion of CNS structural preservation, and (2) reducing the neuroinflammatory response to injury.
This is a multicenter, randomized, blinded, Bayesian CRM dose-escalation placebo-controlled study designed to treat severe, acute TBI in adult patients with an IV infusion of autologous bone marrow mononuclear cells. 55 adult TBI patients will be randomized to receive a single IV infusion of BMMNs (6 x 10^6 or 9 x 10^6) or placebo.
Study subjects will be consecutive admissions of adults with severe TBI meeting inclusion/exclusion criteria. Adults, ages 18-55 years, hospitalized at Memorial Hermann Hospital (Houston, Texas) for severe TBI (GCS 3-8) will be screened for eligibility. Informed consent, the bone marrow/sham harvest, and stem cell/placebo infusion must take place within 48 hours of the initial injury.
Following consent and baseline procedures, subjects will be randomized in a 3:2 ratio (using permuted blocks and stratified by GCS of 3-4 or 5-8) to autologous BMMNC infusion (n=33) and placebo (n = 22), respectively. Administration will begin with the lowest dose (i.e. 6 x 10^6 cells/kg body weight) with each dose given to cohorts of 3 subjects treated with BMMNC (note: the cohort size refers only to subjects treated with autologous BMMNC). After each cohort of 3 subjects treated with autologous BMMNC infusion (accumulated on average after every 5.5 adults randomized), the dosage for the next cohort of 3 autologous BMMNC-treated subjects will be determined by the CRM based on the findings for all subjects previously treated and the prior probabilities of the likelihood of toxicity assigned by the investigators before starting the study. At all doses, the algorithm is designed to avoid administering doses that will have a p(toxicity) exceeding 0.15.
Subjects will be monitored closely for infusion related toxicity and complications during the first 14 days post-infusion while also receiving the usual standard of care for traumatic brain injury . Safety and outcome assessments will be performed at 1, 6, and 12 months post-injury study visits.
- Being tested
- Placebo Infusion, Autologous BMMNC Infusion
- Keywords
- Mesenchymal Stromal Cells, Multipotent, Multipotent Mesenchymal Stromal Cells, Stem Cells, Mesenchymal
- Medical subject headings
- Brain Injuries, Traumatic, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo InfusionBiological
In addition to the standard of care provided to all patients with traumatic brain injury, subjects assigned to the placebo control group will undergo a sham bone marrow harvest and receive a placebo infusion of saline.
Autologous BMMNC InfusionBiological
Also called Stem Cell Infusion
In addition to the standard of care provided to all patients with traumatic brain injury, subjects assigned to the BMMNC treatment group will undergo a bone marrow harvest and then receive an autologous stem cell infusion.
| Study group | Role | What they receive |
|---|---|---|
| Autologous BMMNC Infusion | Experimental | Subjects randomized to the treatment group will undergo a bone marrow harvest and then receive an autologous infusion of BMMNC's starting with the lowest dose (6 x 10^6 cells/kg body weight) and progressing to the high dose of 9 x 10^6 cells/kg body weight using a Bayesian adaptive dose escalation design. Receives: Biological: Autologous BMMNC Infusion |
| Placebo Infusion | Placebo comparator | Subjects randomized to the placebo control group will undergo a "sham" bone marrow harvest. Receives: Biological: Placebo Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macro and micro structural properties of grey matter (GM) and white matter (WM) regions will measured using high-resolution anatomical MRI and diffusion tensorm imaging and comparisons made between groups.
Subjects will undergo three 3T-MRI evaluations. The first will occur 7 to 10 days after hospitalization, when clinically stable. The following five pulse sequences constitute a complete imaging session: 1) conventional localizer/scout 2) 3D isotropic T1-weighted MPRAGE 3) 3D isotropic T2-weighted TSE 4) 32-direction single-shot spin-echo diffusion sensitized echo-planar (DTI-32dir) 5) 3D-FLAIR.
The 3T-MRI will be repeated at 1 and 6 months post-injury. Composite scores will be calculated for comparison.
Measured: up to 6 months. Post Head Injury
Secondary outcomes (7)
Brain imaging measures of GM and WM structural integrity will be compared to functional and neurocognitive scores and comparisons made between groups.
Group differences in functional and neuropsychological outcomes will be assessed. Outcome scores will be correlated with specific macrostructural and microstructural metrics from the MRI. Composite scores will be calculated for comparison.
Measured: Changes From Baseline to 6 mo. Post Head Injury
Compare neuro-inflammatory biomarkers between groups..
CSF and plasma samples will be analyzed for neuro-inflammatory biomarkers and comparisons made between groups.
Measured: Changes From Baseline to 6 mo. Post Head Injury
Measure the number of participants with infusion related adverse events.
Infusion related adverse events will be determined from analysis of standard of care ICU monitoring data and comparisons made between groups.
Measured: up to 6 mo. Post Head Injury
Measure spleen ultrasound size over time and corresponding changes in inflammatory cytokines.
Spleen ultrasound volume will be measured. A comparison of results between groups will help in understanding the contribution of the spleen in the systemic inflammatory responses after acute TBI.
Measured: up to 6 mo. Post Head Injury
Determine if microglial activation is associated with TBI and can be accurately measured with brain PET and DT-MRI imaging when compared to PET imaging data from healthy volunteers (enrolled under a different protocol).
Brain PET and DT-MRI imaging will be obtained 1yr post injury. The outcome measures will be PET-MRI imaging SUV (standardized uptake values) based upon injected dose per patient weight. Voxel-wise analysis of regions of interest (ROI) will focus on: Midbrain, thalamus, hippocampus and cortical subdivisions which will be compared over time and to imaging data from healthy volunteers (enrolled under a different protocol). The SUV in ROIs will be correlated with a battery of functional outcomes measures focusing on the NINDS Common Data Elements. The degree of microglial activation will be correlated with the degree of volumetric loss in specific ROIs.
Measured: 1 yr. Post Head Injury
Quantify the extent and location of microglial activation by brain PET imaging and how activity correlates with performance of neurocognitive outcomes measures.
Brain PET and DT-MRI imaging will be obtained 1yr post injury. The outcome measures will be PET-MRI imaging SUV (standardized uptake values) based upon injected dose per patient weight. Voxel-wise analysis of regions of interest (ROI) will focus on: Midbrain, thalamus, hippocampus and cortical subdivisions which will be compared over time and to imaging data from healthy volunteers (enrolled under a different protocol). The SUV in ROIs will be correlated with a battery of functional outcomes measures focusing on the NINDS Common Data Elements. The degree of microglial activation will be correlated with the degree of volumetric loss in specific ROIs.
Measured: 1 yr. Post Head Injury
Determine the extent to which an IV infusion of autologous BMMNC post-injury impacts microglial activation by brain PET imaging.
Brain PET and DT-MRI imaging will be obtained 1yr post injury. The outcome measures will be PET-MRI imaging SUV (standardized uptake values) based upon injected dose per patient weight. Voxel-wise analysis of regions of interest (ROI) will focus on: Midbrain, thalamus, hippocampus and cortical subdivisions which will be compared over time and to imaging data from healthy volunteers (enrolled under a different protocol). The SUV in ROIs will be correlated with a battery of functional outcomes measures focusing on the NINDS Common Data Elements. The degree of microglial activation will be correlated with the degree of volumetric loss in specific ROIs.
Measured: 1 yr. Post Head Injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2015 (estimated)
- Study start21 Nov 2016
- Primary completionJul 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Injuries, TraumaticStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, U.S. Army Medical Research and Development Command
- Responsible party
- Principal investigator, Charles Cox, The University of Texas Health Science Center, Houston
- Investigators
- Charles S Cox, MD, Principal investigator, UTHealth McGovern Medical School, Houston, TX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02525432
- Sponsor's protocol ID
- HSC-MS-16-0283
- Status last verified
- May 2024
- First submitted
- 23 Mar 2015
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Data will be reported in aggregate.
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Trial of Autologous Bone Marrow Mononuclear Cells for the Treatment of Adult Severe Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT02525432
- Acronym / sponsor ID
- HSC-MS-16-0283
- Keywords
- Mesenchymal Stromal Cells, Multipotent, Multipotent Mesenchymal Stromal Cells, Stem Cells, Mesenchymal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 37 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- United States Department of Defense, U.S. Army Medical Research and Development Command
- Study start
- 21 Nov 2016 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 17 Aug 2015 (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 the effect of intravenous infusion of autologous bone marrow mononuclear cells (BMMNC) on brain structure and neurocognitive/functional outcomes after severe traumatic brain (TBI) injury in adults. The primary objective is to determine if the intravenous infusion of autologous BMMNC after severe TBI results in structural preservation of global gray matter (GM) volume and white matter (WM) volume and integrity; as well as select regions of interest in the corpus callosum. THe secondary objectives are to determine if autologous BMMNC infusion improves functional and neurocognitive deficits in adults after TBI; reduces the neuroinflammatory response to TBI; evaluate spleen size and splenic blood flow over time using ultrasound and corresponding changes in inflammatory cytokines; and infusion related toxicity and long-term follow-up safety evaluations.
Detailed description
Traumatic brain injuries are associated with 33% of all trauma related deaths. There are no effective therapies to treat secondary brain injury and the post-injury response of CNS apoptosis and neuroinflammation. Pre-clinical and Phase I clinical progenitor cell therapies have shown promise in TBI/stroke via (1) promotion of CNS structural preservation, and (2) reducing the neuroinflammatory response to injury.
This is a multicenter, randomized, blinded, Bayesian CRM dose-escalation placebo-controlled study designed to treat severe, acute TBI in adult patients with an IV infusion of autologous bone marrow mononuclear cells. 55 adult TBI patients will be randomized to receive a single IV infusion of BMMNs (6 x 10^6 or 9 x 10^6) or placebo.
Study subjects will be consecutive admissions of adults with severe TBI meeting inclusion/exclusion criteria. Adults, ages 18-55 years, hospitalized at Memorial Hermann Hospital (Houston, Texas) for severe TBI (GCS 3-8) will be screened for eligibility. Informed consent, the bone marrow/sham harvest, and stem cell/placebo infusion must take place within 48 hours of the initial injury.
Following consent and baseline procedures, subjects will be randomized in a 3:2 ratio (using permuted blocks and stratified by GCS of 3-4 or 5-8) to autologous BMMNC infusion (n=33) and placebo (n = 22), respectively. Administration will begin with the lowest dose (i.e. 6 x 10^6 cells/kg body weight) with each dose given to cohorts of 3 subjects treated with BMMNC (note: the cohort size refers only to subjects treated with autologous BMMNC). After each cohort of 3 subjects treated with autologous BMMNC infusion (accumulated on average after every 5.5 adults randomized), the dosage for the next cohort of 3 autologous BMMNC-treated subjects will be determined by the CRM based on the findings for all subjects previously treated and the prior probabilities of the likelihood of toxicity assigned by the investigators before starting the study. At all doses, the algorithm is designed to avoid administering doses that will have a p(toxicity) exceeding 0.15.
Subjects will be monitored closely for infusion related toxicity and complications during the first 14 days post-infusion while also receiving the usual standard of care for traumatic brain injury . Safety and outcome assessments will be performed at 1, 6, and 12 months post-injury study visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autologous BMMNC Infusion | Experimental | Biological: Autologous BMMNC InfusionSubjects randomized to the treatment group will undergo a bone marrow harvest and then receive an autologous infusion of BMMNC's starting with the lowest dose (6 x 10^6 cells/kg body weight) and progressing to the high dose of 9 x 10^6 cells/kg body weight using a Bayesian adaptive dose escalation design. |
| Placebo Infusion | Placebo comparator | Biological: Placebo InfusionSubjects randomized to the placebo control group will undergo a "sham" bone marrow harvest. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adults 18 to 55 years of age on the day of injury,
- Non-penetrating closed head trauma.
- Glasgow Coma Score between (GCS) between 3 and 8, (best un-medicated post-resuscitation score during screening).
- Ability to obtain legally authorized representative consent for participation and complete the BMMNC/Sham harvest and cell/placebo infusion within 48 hours of the initial injury.
- Ability to speak English or Spanish.
Key exclusion criteria (25 listed)
- Known history of:
- Obliteration of perimesencephalic cistern on initial head CT/MRI suggesting prolonged hypoxic ischemic insult;
- Initial hospital ICP > 40 mm Hg;
- Hemodynamic instability at the time of screening defined as SBP < 90mmHg, 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;
- Uncorrectable coagulopathy at the time of screening;
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 |
|---|---|---|
| Placebo InfusionIn addition to the standard of care provided to all patients with traumatic brain injury, subjects assigned to the placebo control group will undergo a sham bone marrow harvest and receive a placebo infusion of saline. | Biological | Placebo Infusion |
| Autologous BMMNC InfusionAlso: Stem Cell InfusionIn addition to the standard of care provided to all patients with traumatic brain injury, subjects assigned to the BMMNC treatment group will undergo a bone marrow harvest and then receive an autologous stem cell infusion. | Biological | Autologous BMMNC Infusion |
Primary outcome
Macro and micro structural properties of grey matter (GM) and white matter (WM) regions will measured using high-resolution anatomical MRI and diffusion tensorm imaging and comparisons made between groups.
Time frame: up to 6 months. Post Head Injury
Subjects will undergo three 3T-MRI evaluations. The first will occur 7 to 10 days after hospitalization, when clinically stable. The following five pulse sequences constitute a complete imaging session: 1) conventional localizer/scout 2) 3D isotropic T1-weighted MPRAGE 3) 3D isotropic T2-weighted TSE 4) 32-direction single-shot spin-echo diffusion sensitized echo-planar (DTI-32dir) 5) 3D-FLAIR. The 3T-MRI will be repeated at 1 and 6 months post-injury. Composite scores will be calculated for comparison.
7 secondary outcomes
Brain imaging measures of GM and WM structural integrity will be compared to functional and neurocognitive scores and comparisons made between groups.
Time frame: Changes From Baseline to 6 mo. Post Head Injury
Compare neuro-inflammatory biomarkers between groups..
Time frame: Changes From Baseline to 6 mo. Post Head Injury
Measure the number of participants with infusion related adverse events.
Time frame: up to 6 mo. Post Head Injury
Measure spleen ultrasound size over time and corresponding changes in inflammatory cytokines.
Time frame: up to 6 mo. Post Head Injury
Determine if microglial activation is associated with TBI and can be accurately measured with brain PET and DT-MRI imaging when compared to PET imaging data from healthy volunteers (enrolled under a different protocol).
Time frame: 1 yr. Post Head Injury
Quantify the extent and location of microglial activation by brain PET imaging and how activity correlates with performance of neurocognitive outcomes measures.
Time frame: 1 yr. Post Head Injury
Determine the extent to which an IV infusion of autologous BMMNC post-injury impacts microglial activation by brain PET imaging.
Time frame: 1 yr. Post Head Injury
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Individual participant dataSharing planned: No. Data will be reported in aggregate.
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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, MD principal investigator
UTHealth McGovern Medical School, Houston, TX
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Autologous BMMNC Infusion in people with Brain Injuries, Traumatic and Brain Injuries, Acute, run by The University of Texas Health Science Center, Houston 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 25 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: status not confirmed, as of the sponsor's last update on 9 May 2024. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
Results are not available in the source record.
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?
Macro and micro structural properties of grey matter (GM) and white matter (WM) regions will measured using high-resolution anatomical MRI and diffusion tensorm imaging and comparisons made between groups. (time frame: up to 6 months. Post Head Injury). 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 9 May 2024.