NCT01113307

The Use of CureXcellTM in a Community Setting for the Treatment of Hard to Heal Wounds

A Multi-Center Post- Marketing Study to Define Procedures for the Use of CureXcellTM in a Community Setting for the Treatment of Wounds

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 131 (actual)
• Sponsor: Macrocure Ltd. · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to define procedures for the use of CureXcellTM in the community through Clalit Health Services. Secondary objective is to evaluate the blinding method in a subgroup of patients, which will be used in a future study named: a multinational, multi-center, randomized, double blind, placebo controlled study for the evaluation of the tolerability, safety and efficacy of CureXcell™ therapy plus adequate ulcer treatment, in diabetic patients with ulcers in the lower extremities. Adults with chronic ulcers; pressure ulcers, venous ulcers, diabetic foot ulcers or post operative ulcer will be recruited to the study. Patients that have been recruited for the study will be treated as required for their medical condition. As required, cultures will be taken, IV or PO antibiotics will be given and debridement will be carried out. Patients will be referred to catheterization, revascularization, or amputation as required and the decision to do so will not be affected in any way by the study. CureXcellTM will be used as adjunct treatment to good ulcer care (GUC).

Conditions

• Wounds

Interventions

Type	Name	Description
BIOLOGICAL	Activated allogeneic white blood cells	The CUREXCELL™ dosage form consists of an activated cell suspension that has been isolated, activated and purified from the peripheral blood of healthy allogeneic donors, by hypo-osmotic shock, using the MacroCure custom closed bag system.The cell suspension is superficially injected throughout the wound bed ( 0.1ml per 1 cm2 of wound bed).

Timeline

• Start date: 2010-05-01
• Primary completion: 2011-07-01
• Completion: 2011-09-01
• First posted: 2010-04-29
• Last updated: 2013-01-31

Locations

7 sites across 1 country: Israel