A Phase 2 Exploratory Pharmacodynamic Study of HP802-247 in Venous Leg Ulcers

Study Overview
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Brief Summary
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Assess the influence of HP802-247 on biochemical and cellular markers of inflammation in chronic venous leg ulcers

Official Title
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A Phase 2 Exploratory Pharmacodynamic Study of HP802-247 in Venous Leg Ulcers

Conditions
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Venous Leg Ulcers

Intervention / Treatment
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* Biological: HP802-247


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provide informed consent Age ≥ 18 years and of either sex Willing to comply with protocol instructions, including allowing all study assessments Have a venous leg ulcer (VLU) between the knee and ankle (at or above the malleolus), with a surface area ≥ 4.0 cm x cm and ≤ 15.0 cm x cm Venous insufficiency confirmed by duplex Doppler ultrasound examination for valvular or venous incompetence Arterial supply adequacy confirmed Target ulcer involves a full thickness skin loss, but WITHOUT exposure of tendon, muscle, or bone Target ulcer duration ≥ 12 weeks but ≤ 104 weeks (24 months). Acceptable state of health and nutrition Exclusion Criteria: History of anaphylaxis, serum sickness, or erythema multiforme reaction to aprotinin, bovine serum albumin or bovine serum proteins, penicillin, streptomycin, amphotericin B or any other component of HP802-247,or known sensitivity to Iodine Prior diagnosis of Systemic Lupus Erythematosus with elevated anti-DNA antibody titers, Buerger's disease (thromboangiitis obliterans), current diagnosis of vasculitis, or current diagnosis of claudication Therapy with another investigational agent within thirty (30) days of Screening, or during the study, or any participation in a previous HP802-247 trial A target ulcer of non-venous etiologies (e.g., sickle cell anemia, necrobiosis lipoidica diabeticorum, pyoderma gangrenosum, vasculopathic or vasculitic) Documented history of osteomyelitis at the target wound location within 6 months preceding the Screening Visit Refusal of or inability to tolerate compression therapy Therapy of the target ulcer with Collagenase Santyl® ointment, autologous skin graft, biological dressings or living cell products (e.g., Oasis®, Apligraf™, Dermagraft™) within 30 days preceding the Screening Visit Therapy of the target ulcer with topical growth factors within 1 week preceding the Screening Visit Current therapy with systemic antibiotics Current systemic therapy with cytotoxic drugs Current therapy with chronic (> 10 days) oral corticosteroids Current therapy with TNFα inhibitors History of cancer in the preceding 5 years (other than carcinoma in situ of the cervix or adequately treated non-melanoma skin cancers)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HP802-247<br> | Biological: HP802-247<br>* 260 µL (130 µL, one spray, of each component) containing 0.5 x 10.6 cells per mL, alternating weekly with Vehicle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Venous leg ulcer, Ulcer, Venous stasis, Compression