Trauma InjuryNCT02577731
Hematopoietic Stem Cell Dysfunction in the Elderly After Severe Injury
A study testing Bone marrow collection, Blood collection and Clinical data collection in people with Trauma Injury, run by University of Florida at 1 site in United States.
Trial summary
Traumatic injury is a leading cause of morbidity and mortality in young adults, and remains a substantial economic and health care burden. Despite decades of promising preclinical and clinical investigations in trauma, investigators understanding of these entities is still incomplete, and few therapies have shown… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma Injury
- What is being tested?
- Bone marrow collection, Blood collection and Clinical data collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adults (age ≥18 to 54)
- Blunt and/or penetrating trauma resulting in long bone or pelvic fractures requiring ORIF or closed reduction percutaneous pinning (CRPP).
- Blunt and/or penetrating trauma patient with either:
- hemorrhagic shock defined by: i. systolic BP (SBP) ≤ 90 mmHg or ii. mean arterial pressure≤ 65 mmHg or iii. base deficit (BD) ≥ 5 meq or iv. lactate ≥ 2
- Or injury severity score (ISS) greater than or equal to 15.
- All adults (age 55 and older) require:
Show all 13Show fewer
- Blunt and/or penetrating trauma resulting in log bone or pelvic fractures requiring ORIF or CRPP
- Either hemorrhagic shock defined by: i. Systolic BP (SBP) ≤ 90 mmHg or ii. Mean arterial pressure ≤ 65 mmHg or iii. Base deficit (BD) ≥5 meq or iv. Lactate ≥ 2
- Or Injury Severity Score (ISS) greater than or equal to 15.
- Ability to obtain Informed Consent prior to OR repair of injury.
- All adults (age ≥18)
- Patient undergoing elective hip repair for non-infectious reasons.
- Ability to obtain Informed Consent prior to operation.
Who cannot join
- Patients not expected to survive greater than 48 hours.
- Prisoners.
- Pregnancy.
- Patients receiving chronic corticosteroids or immunosuppression therapies.
- Previous bone marrow transplantation.
- Patients with End Stage Renal Disease.
Show all 14Show fewer
- Patients with any pre-existing hematological disease.
- Elective Hip Repair Population
- Pregnancy.
- Prisoners.
- Patients receiving chronic corticosteroids or immunosuppression therapies.
- History of receiving Chemotherapy or Radiation within the last 6 months
- Previous bone marrow transplantation
- 7. Patients with End Stage Renal Disease 8. Patients with any pre-existing hematological disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UF Health Shands Hospital at the University of Florida
Gainesville, Florida, 32610
Jennifer Lanz, MSN, 352-273-5497, jennifer.lanz@surgery.ufl.edu
Ruth Davis, ASN, 352-273-8759, ruth.davis@surgery.ufl.edu
About this study
Official title: Hematopoietic Stem Cell Dysfunction in the Elderly After Severe Injury: Chronic Stress and Anemia Recovery Following Major Trauma
Traumatic injury is a leading cause of morbidity and mortality in young adults, and remains a substantial economic and health care burden. Despite decades of promising preclinical and clinical investigations in trauma, investigators understanding of these entities is still incomplete, and few therapies have shown success. During severe trauma, bone marrow granulocyte stores are rapidly released into the peripheral circulation. This release subsequently induces the expansion and repopulation of empty or evacuated space by hematopoietic stem cells (HSCs). Although the patient experiences an early loss of bone marrow myeloid-derived cells, stem cell expansion is largely skewed towards the repopulation of the myeloid lineage/compartment. The hypothesis is that this 'emergency myelopoiesis' is critical for the survival of the severely traumatized and further, failure of the emergency myelopoietic response is associated with global immunosuppression and susceptibility to secondary infection. Also, identifying the release of myeloid derived suppressor cells (MDSCs) in the circulation of human severe trauma subjects. This process is driven by HSCs in the bone marrow of trauma subjects. Additionally, MDSCs may have a profound effect on the nutritional status of the host. The appearance of these MDSCs after trauma is associated with a loss of muscle tissue in these subjects. This muscle loss and possible increased catabolism have huge effects on long term outcomes for these subjects. It is the investigator's goal to understand the differences that occur in these in HSCs and muscle cells as opposed to non-injured and non-infected controls. This work will lead to a better understanding of the myelopoietic and catabolic response following trauma.
Read the detailed description
This is a prospective study to understand how trauma injuries changes the hematopoeitic stem cells (HSCs) in the bone marrow and muscle cells after trauma injury in elderly subjects is different when compared to non-injured subjects.
There will be three groups for this study: 1) Elective hip surgery subjects, 2) Trauma subjects and 3) deidentified bone marrow of healthy controls.
Samples of bone marrow and a blood sample will be collected at the time of surgery. The deidentified bone marrow of healthy controls will come from a tissue bank.
The blood will be used to perform PB colony assays, ELISAs to test for the following parameters: EPO, G-CSF, Reticulocyte, iron levels and cytokines and inflammatory markers.
The bone marrow and blood samples will be processed and sorted to isolate hematopoeitic stem cells for genomic content to determine genomic expression, oxidative stress, mitochondrial activity, apoptosis, autophagy, analysis of circulating erythroid progenitor cells, reticulocytes, granulocyte-colony stimulating factor assays, erythropoietin and iron levels.
Clinical data and hemodynamic measurements will be collected daily while subjects are hospitalized and trauma surgery subjects will be followed to evaluate for malunion and subsequent additional surgical procedures for repair.
- Conditions
- Trauma Injury
- Being tested
- Bone marrow collection, Blood collection, Clinical data collection
- Keywords
- Trauma
- Medical subject headings
- Accidental Injuries, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone marrow collectionOther
Bone marrow will be collected from the patient at time of orthopedic repair in the operating room. A second sample may be collected if the patient is required to return to the operating room for further repair of orthopedic injury.
Blood collectionOther
Blood sample collection will be collected from the patient at time of orthopedic repair in the operating room. A second sample may be collected if the patient is required to return to the operating room for further repair of orthopedic injury.
Clinical data collectionOther
Clinical data collection will encompass demographic information, past and present medical records, laboratory, microbiology, and all other test results, x-ray, CT, MRI, US and all other imaging test results, records about any medication received during admission, records of physical exam during admission, records of all vital signs and hemodynamic monitoring during admission, records of any procedure or intervention during admission, records of any procedure or intervention during hospital admission, condition at the discharge and discharge facility.
| Study group | Role | What they receive |
|---|---|---|
| Severe Trauma | Other | Bone marrow collection. Blood collection. Clinical data collection. Receives: Other: Bone marrow collection; Other: Blood collection; Other: Clinical data collection |
| Elective Hip Repair | Other | Bone marrow collection. Blood collection. Clinical data collection. Receives: Other: Bone marrow collection; Other: Blood collection; Other: Clinical data collection |
| Healthy Young Bone Marrow Control | Other | Deidentified freshly isolated bone marrow samples from healthy young control subjects will be purchased for a tissue bank. Receives: Other: Bone marrow collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analyze the genomics response of hematopoietic cells between the groups
Through negative isolation columns and flow sorting to isolate the hematopoietic stem cells (HSCs) from a sample for appropriate analysis. The sample will then be enriched using a lineage depletion column which will remove all mature hematopoietic cells. The HSCs will be phenotyped and sorted as CD34+ CD38- Thy1+ CD45RA-. HSCs will be lysed and the RNA genomic content will be isolated. The genomic content will then be processed onto a GeneChip® microarray to analyze the genomic expression.
Measured: Baseline
Analyze the muscle dysfunction between the groups for oxidative stress
Measured: Baseline
Analyze the muscle dysfunction between the groups for mitochondrial activity
Measured: Baseline
Analyze the muscle dysfunction between the groups for apoptosis
Measured: Baseline
Analyze the muscle dysfunction between the groups for autophagy
Measured: Baseline
Secondary outcomes (2)
The pathophysiology of injury-associated persistent anemia through PB colony assays of blood.
Measured: Baseline
The pathophysiology of injury-associated persistent anemia through ELISA test of blood.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2015 (estimated)
- Study startJan 2014
- Primary completion28 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Trauma InjuryStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
- Investigators
- Philip Efron, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02577731
- Sponsor's protocol ID
- IRB201601386-N
- Other IDs
- 1R01GM113945-01, IRB 106-2013, 5R01GM105893, OCR30562
- Status last verified
- Apr 2025
- First submitted
- 1 Oct 2015
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Munley JA, Willis ML, Gillies GS, Kannan KB, Polcz VE, Balch JA, Barrios EL, Wallet SM, Bible LE, Efron PA, Maile R, Mohr AM. Exosomal microRNA following severe trauma: Role in bone marrow dysfunction. J Trauma Acute Care Surg. 2024 Apr 1;96(4):548-556. doi: 10.1097/TA.0000000000004225. Epub 2023 Dec 28.
PubMed 38151766Munley JA, Kelly LS, Gillies GS, Kannan KB, Pons EE, Bible LE, Efron PA, Mohr AM. EFFECTS OF TRAUMA PLASMA-DERIVED EXOSOMES ON HEMATOPOIETIC PROGENITOR CELLS. Shock. 2023 Apr 1;59(4):591-598. doi: 10.1097/SHK.0000000000002094. Epub 2023 Feb 16.
PubMed 36772985
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hematopoietic Stem Cell Dysfunction in the Elderly After Severe Injury: Chronic Stress and Anemia Recovery Following Major Trauma
- ClinicalTrials.gov ID
- NCT02577731
- Acronym / sponsor ID
- IRB201601386-N
- Conditions
- Trauma Injury
- Keywords
- Trauma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- Jan 2014 (actual)
- Primary completion
- 28 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 Oct 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.
Traumatic injury is a leading cause of morbidity and mortality in young adults, and remains a substantial economic and health care burden. Despite decades of promising preclinical and clinical investigations in trauma, investigators understanding of these entities is still incomplete, and few therapies have shown success. During severe trauma, bone marrow granulocyte stores are rapidly released into the peripheral circulation. This release subsequently induces the expansion and repopulation of empty or evacuated space by hematopoietic stem cells (HSCs). Although the patient experiences an early loss of bone marrow myeloid-derived cells, stem cell expansion is largely skewed towards the repopulation of the myeloid lineage/compartment. The hypothesis is that this 'emergency myelopoiesis' is critical for the survival of the severely traumatized and further, failure of the emergency myelopoietic response is associated with global immunosuppression and susceptibility to secondary infection. Also, identifying the release of myeloid derived suppressor cells (MDSCs) in the circulation of human severe trauma subjects. This process is driven by HSCs in the bone marrow of trauma subjects. Additionally, MDSCs may have a profound effect on the nutritional status of the host. The appearance of these MDSCs after trauma is associated with a loss of muscle tissue in these subjects. This muscle loss and possible increased catabolism have huge effects on long term outcomes for these subjects. It is the investigator's goal to understand the differences that occur in these in HSCs and muscle cells as opposed to non-injured and non-infected controls. This work will lead to a better understanding of the myelopoietic and catabolic response following trauma.
Detailed description
This is a prospective study to understand how trauma injuries changes the hematopoeitic stem cells (HSCs) in the bone marrow and muscle cells after trauma injury in elderly subjects is different when compared to non-injured subjects.
There will be three groups for this study: 1) Elective hip surgery subjects, 2) Trauma subjects and 3) deidentified bone marrow of healthy controls.
Samples of bone marrow and a blood sample will be collected at the time of surgery. The deidentified bone marrow of healthy controls will come from a tissue bank.
The blood will be used to perform PB colony assays, ELISAs to test for the following parameters: EPO, G-CSF, Reticulocyte, iron levels and cytokines and inflammatory markers.
The bone marrow and blood samples will be processed and sorted to isolate hematopoeitic stem cells for genomic content to determine genomic expression, oxidative stress, mitochondrial activity, apoptosis, autophagy, analysis of circulating erythroid progenitor cells, reticulocytes, granulocyte-colony stimulating factor assays, erythropoietin and iron levels.
Clinical data and hemodynamic measurements will be collected daily while subjects are hospitalized and trauma surgery subjects will be followed to evaluate for malunion and subsequent additional surgical procedures for repair.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Severe Trauma | Other | Other: Bone marrow collection, Other: Blood collection, Other: Clinical data collectionBone marrow collection. Blood collection. Clinical data collection. |
| Elective Hip Repair | Other | Other: Bone marrow collection, Other: Blood collection, Other: Clinical data collectionBone marrow collection. Blood collection. Clinical data collection. |
| Healthy Young Bone Marrow Control | Other | Other: Bone marrow collectionDeidentified freshly isolated bone marrow samples from healthy young control subjects will be purchased for a tissue bank. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- All adults (age ≥18 to 54)
- Blunt and/or penetrating trauma resulting in long bone or pelvic fractures requiring ORIF or closed reduction percutaneous pinning (CRPP).
- Blunt and/or penetrating trauma patient with either:
- All adults (age 55 and older) require:
- Ability to obtain Informed Consent prior to OR repair of injury.
Key exclusion criteria (14 listed)
- Patients not expected to survive greater than 48 hours.
- Prisoners.
- Pregnancy.
- Patients receiving chronic corticosteroids or immunosuppression therapies.
- Previous bone marrow transplantation.
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 |
|---|---|---|
| Bone marrow collectionBone marrow will be collected from the patient at time of orthopedic repair in the operating room. A second sample may be collected if the patient is required to return to the operating room for further repair of orthopedic injury. | Other | Elective Hip Repair, Healthy Young Bone Marrow Control, Severe Trauma |
| Blood collectionBlood sample collection will be collected from the patient at time of orthopedic repair in the operating room. A second sample may be collected if the patient is required to return to the operating room for further repair of orthopedic injury. | Other | Elective Hip Repair, Severe Trauma |
| Clinical data collectionClinical data collection will encompass demographic information, past and present medical records, laboratory, microbiology, and all other test results, x-ray, CT, MRI, US and all other imaging test results, records about any medication received during admission, records of physical exam during admission, records of all vital signs and hemodynamic monitoring during admission, records of any procedure or intervention during admission, records of any procedure or intervention during hospital admission, condition at the discharge and discharge facility. | Other | Elective Hip Repair, Severe Trauma |
Primary outcome
Analyze the genomics response of hematopoietic cells between the groups
Time frame: Baseline
Through negative isolation columns and flow sorting to isolate the hematopoietic stem cells (HSCs) from a sample for appropriate analysis. The sample will then be enriched using a lineage depletion column which will remove all mature hematopoietic cells. The HSCs will be phenotyped and sorted as CD34+ CD38- Thy1+ CD45RA-. HSCs will be lysed and the RNA genomic content will be isolated. The genomic content will then be processed onto a GeneChip® microarray to analyze the genomic expression.
Analyze the muscle dysfunction between the groups for oxidative stress
Time frame: Baseline
Analyze the muscle dysfunction between the groups for mitochondrial activity
Time frame: Baseline
Analyze the muscle dysfunction between the groups for apoptosis
Time frame: Baseline
Analyze the muscle dysfunction between the groups for autophagy
Time frame: Baseline
2 secondary outcomes
The pathophysiology of injury-associated persistent anemia through PB colony assays of blood.
Time frame: Baseline
The pathophysiology of injury-associated persistent anemia through ELISA test of blood.
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Derived from this study: PubMed 38151766Munley JA, Willis ML, Gillies GS, Kannan KB, Polcz VE, Balch JA, Barrios EL, Wallet SM, Bible LE, Efron PA, Maile R, Mohr AM. Exosomal microRNA following severe trauma: Role in bone marrow dysfunction. J Trauma Acute Care Surg. 2024 Apr 1;96(4):548-556. doi: 10.1097/TA.0000000000004225. Epub 2023 Dec 28.
- Derived from this study: PubMed 36772985Munley JA, Kelly LS, Gillies GS, Kannan KB, Pons EE, Bible LE, Efron PA, Mohr AM. EFFECTS OF TRAUMA PLASMA-DERIVED EXOSOMES ON HEMATOPOIETIC PROGENITOR CELLS. Shock. 2023 Apr 1;59(4):591-598. doi: 10.1097/SHK.0000000000002094. Epub 2023 Feb 16.
Related trials for Trauma Injury
Enrolling by invitation
Risk Assessment of Mild Traumatic Brain Injury in Military Training
Trauma, Brain
Enrolling by invitationPhase 4
PPP Versus Corticosteroid for Thigh Muscle Injuries
Thigh Muscle Injury, Thigh Injury
Not yet recruitingObservational study
Results of Medical and Nursing Record,Physical Examination, Blood Test and Radiological Examination of Multiple Trauma to Find the Correlation With Patient's Morality and Mobility
Trauma Centers/Statistics & Numerical Data, Trauma Blunt
RecruitingPhase 4
Nonopioid Pain Control Regimen After Open Reduction and Internal Fixation of Traumatic Fractures
Opioid Use, Fractures, Bone
RecruitingObservational study
Collecting the Results of Multiple Trauma Patients and Find the Correlation of Morality and Mobility
Multiple Trauma/Injuries
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.
Philip Efron, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bone marrow collection, Blood collection and Clinical data collection in people with Trauma Injury, run by University of Florida 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 13 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 15 Jan 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer D Lanz, MSN (352-273-5497, jennifer.lanz@surgery.ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analyze the genomics response of hematopoietic cells between the groups (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02577731, which also lists 2 linked publications.
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 15 Jan 2026; AzTrials last refreshed its copy on 30 Oct 2026.