Trial of Compassionate Use of hp802-247 to Treat Venous Leg Ulcers in Subjects Who Have Failed Multiple Other Healing Technologies

Atlantic Health System

Status and phase: Unknown; Phase 2

Conditions: Venous Leg Ulcer

Treatments: Biological: Weekly wound spray with components 1 and 2 of the compound HP802-247

Study type: Interventional

Funder types: Other

Identifiers

NCT01320605

E001

Details and patient eligibility

About

Compound HP802-247 comprises two topical sprays, administered sequentially right after another; these deliver a suspension of fibroblasts and keratinocytes to the wound surface. HP802-247 is the subject of a larger Phase 2 multi-center trial for treating venous leg ulcers. The present study will enroll up to five patients who are suffering venous leg ulcers, have failed a prolonged course of standard wound therapy and one or more advanced technologies, but who would not qualify for the Phase 2 study.

Enrollment: 5 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic (duration greater than six months) open wound that has been diagnosed as a venous leg ulcer on the basis of consultation with a vascular surgeon and/or venous ultrasound evaluation
• Patient has been under continuous care at the Overlook Hospital Wound Healing Program for at least four months for treatment of the study lesion(s)
• Total study wound surface area greater than or equal to 12 cm2, but less than 48 cm2
• Wounds must have failed to heal despite the patient's compliance with elevation, compression and regular debridement, as well as at least one advanced wound therapy (for example, bioengineered dressing such as Oasis® or MatriStem®, low-frequency ultrasound, or cultured skin substitute (Apligraf®, Dermagraft®)
• Patient has no reasonable likelihood of healing with additional attempts to treat with FDA-approved products and treatments

Exclusion criteria

• Patients eligible to participate in a Healthpoint sponsored clinical study of HP802-247 trial (IND 13,900)
• Patients who have been previously treated with HP802-247
• Women of child-bearing potential
• Patients who are allergic to any of the components of HP802-247

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Weekly HP802247 treatment

Experimental group

Treatment:

Biological: Weekly wound spray with components 1 and 2 of the compound HP802-247