A Phase 2 Exploratory Pharmacodynamic Study of HP802-247 in Venous Leg Ulcers
Condition: Venous Leg Ulcers
MeSH terms: Varicose Ulcer; Leg Ulcer; Ulcer
Intervention: HP802-247
Intervention description: 260 µL (130 µL, one spray, of each component) containing 0.5 x 10.6 cells per mL, alternating weekly with Vehicle
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Venous leg ulcer; Ulcer; Venous stasis; Compression

Summary:

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

Eligibility criteria:

        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)