Hematopoietic Stem Cell Dysfunction in the Elderly After Severe Injury

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT02577731
Status
Recruiting
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Conditions

  • Trauma Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bone marrow collection — OTHER
    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 collection — OTHER
    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 collection — OTHER
    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 Details

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.

Key Dates

Start date
Jan 31, 2014
Status verified
Apr 2025
Primary completion
Dec 28, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
400 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Other: Severe Trauma
    Bone marrow collection. Blood collection. Clinical data collection.
  • Other: Elective Hip Repair
    Bone marrow collection. Blood collection. Clinical data collection.
  • Other: Healthy Young Bone Marrow Control
    Deidentified freshly isolated bone marrow samples from healthy young control subjects will be purchased for a tissue bank.

Primary Outcome Measure

Analyze the genomics response of hematopoietic cells between the groups [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UF Health Shands Hospital at the University of FloridaGainesvilleFlorida32610
Jennifer Lanz, MSN
[email protected]
352-273-5497
Ruth Davis, ASN
[email protected]
352-273-8759
Frederick Moore, MD (SUB_INVESTIGATOR)
Christiaan Leeuwenburgh, PhD (SUB_INVESTIGATOR)
Alicia Mohr, MD (SUB_INVESTIGATOR)
Moldawer Lyle, MD (SUB_INVESTIGATOR)
Kalia Sadasivan, MD (SUB_INVESTIGATOR)
Hari Parvateneni, MD (SUB_INVESTIGATOR)
Philip Efron, MD (PRINCIPAL_INVESTIGATOR)

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By research site
UF Health Shands Hospital at the University of Florida· Gainesville, FL

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