- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00796627
Hypoxia-inducible Factor-1 (HIF-1) Regulated Circulating Angiogenic Cells (CACs) Recruitment in Burn Wound Healing
HIF-1 Regulated Circulating Angiogenic Cell Recruitment in Burn Wound Healing
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Burn injuries represent a major public health problem, requiring medical attention for more than one million Americans annually. Despite therapeutic advances, non-healing burn wounds and excessive scarring still result in significant long term physical and psychosocial morbidity. In this study we propose to perform clinical and research to study the role of circulating angiogenic cells (CAC) in promoting burn wound healing.
CAC's have been shown to contribute to vascularization and tissue repair in a number of animal models of tissue injury ischemia and mobilization of CACs into the peripheral blood has been demonstrated in burn wound patients.
We hypothesize that primary healing of burn wounds is dependent on repair of damaged vasculature, and that bone marrow derived stem cells, circulating angiogenic cells (CAC), play a critical role in the healing process. Furthermore we propose that the transcription factor Hypoxia Inducible Factor 1 alpha (HIF 1 alpha) through production of peptide products of its downstream target genes directs the "homing" of CAC's to the wound where they participate in healing events. The first aim of this study is to correlate mobilization of CAC's into the blood stream with the success of burn wound healing.
CAC's have been shown to contribute to vascularization and tissue repair in a number of studies. The relationship between mobilization of CAC's and burn wound healing has not been examined. In addition to surveying CAC numbers in the peripheral blood, we will assay levels of the putative mediators of CAC mobilization: Vascular Endothelial Growth Factor (VEGF), Placenta Growth Factor (PLGF), and Stromal Cell-Derived Factor (SDF-1). We hypothesize that individuals who are able to mount a large and sustained mobilization of CAC's into the peripheral blood from the bone marrow, will be more likely to heal the injured vasculature and go on to primary healing. Individuals with an inadequate mobilization of CAC's will fail to repair the damaged vasculature in the wound and proceed to necrosis and "conversion" to third degree, necrotic burn wounds.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21224
- Johns Hopkins Bayview Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Recruitment of patients at the Johns Hopkins Regional Burn Center for study will be based upon the following clinical criteria:
- Second degree scald burn of 10 cm2
- Age between 14 to 75 years
- Burn area equal or less than 95% of Burn Surface Area (BSA)
- Body temperature between 98.5 and 101 degree F
- Informed consent for enrolment into study
- Spanish speaking patients will be included when we have a Spanish consent form available.
Exclusion Criteria:
- First and third degree burn wounds
- Hemodynamic instability (SBP below 100, Heart Rate (HR) over 100, urine output less than 30 ml/hour
- Area of burn over 20% of BSA
- Hypothermia T<98.5 or Hyperthermia T>101 degree F
- Urine output less than 30 ml/hour
- Serum albumin less than 3 mg/ml.
- Subjects weighing less than 50 kg.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Sham Comparator: Healthy volunteers
Healthy volunteers with no burn wounds Volunteers donate blood that will be studied in comparison to patients who have sustained burns.
The circulating "bone marrow stem cells" will be counted and compared to the levels in burn patients.
Six 12 ml tubes will be taken for the study.
You will not be compensated.
But you will be helping to advance science if you join the study.
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Comparison of healthy volunteers to burn wounded volunteers
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Active Comparator: Burn volunteer
To recruit burn wound patients with defined clinical criteria for study.
A second-degree burn of at least 10 cm2 to up to 95% BSA; age = 14-75 years; BP > 100 mm Hg systolic; heart rate < 100 beats/minute; urine output > 30 ml/hour; area of burn < 20% of BSA; body temperature = 98.5-101 degrees Fahrenheit; serum albumin > 3 mg/ml; and informed consent.
We will also obtain a history regarding the presence or absence of risk factors that may affect CAC numbers: hypertension > 1 year; smoking > 2 pack-years or within the last year; diabetes mellitus; and family history of premature coronary artery disease (men < 55 and women < 65 years of age).Six 12 ml tubes will be taken at 5 time points
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Comparison of burn wounded volunteers to healthy volunteers
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Quantification of Circulating Angiogenic Cells in the Blood of Individuals Who Are Healthy Volunteers Compared to Those in Individuals Who Have Sustained a Burn Injury
Time Frame: baseline
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Tissue samples were harvested from healthy volunteers and participants who sustained burns.
CACs were isolated and counted under fluorescence microscopy.
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baseline
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Mean of Circulating Angiogenic Cells in the Blood of Individuals Who Have Sustained a Burn Injury
Time Frame: 0 to 24 hours post-operative
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Tissue samples were harvested from healthy volunteers and participants who sustained burns.
CACs were isolated and counted under fluorescence microscopy.
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0 to 24 hours post-operative
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Mean of Circulating Angiogenic Cells in the Blood of Individuals Who Have Sustained a Burn Injury
Time Frame: 49 to 72 hours post-operative
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Tissue samples were harvested from healthy volunteers and participants who sustained burns.
CACs were isolated and counted under fluorescence microscopy.
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49 to 72 hours post-operative
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Mean of Circulating Angiogenic Cells in the Blood of Individuals Who Have Sustained a Burn Injury
Time Frame: 73 hours to 6 weeks post-operative
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Tissue samples were harvested from healthy volunteers and participants who sustained burns.
CACs were isolated and counted under fluorescence microscopy.
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73 hours to 6 weeks post-operative
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: John Harmon, MD, Johns Hopkins University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NA_00018037
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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