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based on outcome of previous study
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Assess the influence of HP802-247 on biochemical and cellular markers of inflammation in chronic venous leg ulcers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HP802-247 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HP802-247 | Biological | 260 µL (130 µL, one spray, of each component) containing 0.5 x 10.6 cells per mL, alternating weekly with Vehicle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determine Change From Baseline in Cell Numbers in Subjects With VLU Following the First Dose of HP802-247 | The following mediators were to be measured for the chronic ulcer stage: IL-1β, IL-6, TNF-α, IFN, MMP-2, and MMP-9, and the following for the resolving ulcer stage: PGE-2, Lipoxin, GM-CSF, TGFβ, IL-10, LL-37, Indoleamine 2,3-Dioxygenase (IDO), and Arginase (ARG-1). Each of the soluble mediators were to be plotted versus measurement time point [i.e., (pre-study run-in visit (RV)1), baseline (RV3), study visit (SV)2, and SV3]) and by subjects' quartile of percent reduction (%) in target wound area at SV3 from baseline (RV3). | Wound fluid samples were to be collected one week after the initial dose of HP802-247. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Herbert B Slade, MD | Smith & Nephew Biotherapeutics; Chief Medical Officer | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbus | Ohio | 42305 | United States |
Subjects entered a 2-week run-in; subjects whose wound radius decreased by < 0.349 cm/2weeks and met all other inclusion/exclusion (I/E) criteria were eligible for randomization.
HP802-247
Subjects were enrolled at a single US investigation site, between July 14,2014 and November 2, 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | HP802-247 | HP802-247: 260 µL (130 µL, one spray, of each component) containing 0.5 x 10.6 cells per mL, alternating weekly with Vehicle HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth-arrested keratinocytes and fibroblasts) applied every 2 weeks, with Vehicle (fibrinogen solution & acellular thrombin solution) on alternate weeks, for up to 12 weeks, or until wound closure occurred, which ever came first |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | HP802-247 | HP802-247: 260 µL (130 µL, one spray, of each component) containing 0.5 x 10.6 cells per mL, alternating weekly with Vehicle HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth-arrested keratinocytes and fibroblasts) applied every 2 weeks, with Vehicle (fibrinogen solution & acellular thrombin solution) on alternate weeks, for up to 12 weeks, or until wound closure occurred, which ever came first |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Determine Change From Baseline in Cell Numbers in Subjects With VLU Following the First Dose of HP802-247 | The following mediators were to be measured for the chronic ulcer stage: IL-1β, IL-6, TNF-α, IFN, MMP-2, and MMP-9, and the following for the resolving ulcer stage: PGE-2, Lipoxin, GM-CSF, TGFβ, IL-10, LL-37, Indoleamine 2,3-Dioxygenase (IDO), and Arginase (ARG-1). Each of the soluble mediators were to be plotted versus measurement time point [i.e., (pre-study run-in visit (RV)1), baseline (RV3), study visit (SV)2, and SV3]) and by subjects' quartile of percent reduction (%) in target wound area at SV3 from baseline (RV3). | Due to the failure of HP802-247-09-029 to show superiority over its vehicle in study 802-247-09-029, this study was terminated after enrollment of one of the proposed 25 subjects. No data was collected. | Posted | Wound fluid samples were to be collected one week after the initial dose of HP802-247. |
|
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Adverse events were not monitored for the participants due to the early termination of the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HP802-247 | HP802-247: 260 µL (130 µL, one spray, of each component) containing 0.5 x 10.6 cells per mL, alternating weekly with Vehicle HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth-arrested keratinocytes and fibroblasts) applied every 2 weeks, with Vehicle (fibrinogen solution & acellular thrombin solution) on alternate weeks, for up to 12 weeks, or until wound closure occurred, which ever came first |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jaime E Dickerson, PhD | Smith & Nephew, Inc | 1-817-302-3914 | Jaime.Dickerson@smith-nephew.com |
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| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| D014456 | Ulcer |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
HP802-247: 260 µL (130 µL, one spray, of each component) containing 0.5 x 10.6 cells per mL, alternating weekly with Vehicle HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth-arrested keratinocytes and fibroblasts) applied every 2 weeks, with Vehicle (fibrinogen solution & acellular thrombin solution) on alternate weeks, for up to 12 weeks, or until wound closure occurred, which ever came first |
|
| 0 |
| 0 |
| 0 |
| 0 |
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| D012883 |
| Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |