Evaluation of CureXcell® in Treating Chronic Venous Leg Ulcers

Macrocure

Status and phase: Unknown; Phase 3

Conditions: Chronic Venous Leg Ulcers

Treatments: Other: Placebo injection; Biological: CureXcell®

Study type: Interventional

Funder types: Industry

Identifiers

NCT02130310

MC-105

Details and patient eligibility

About

The primary objective is to evaluate the clinical benefit of CureXcell® as adjunct to Standard of Care in the treatment of Chronic Venous Leg Ulcers. CureXcell® is a cell based therapy, containing activated homologous white blood cells prepared from donated healthy whole blood. A total of 252 patients will be randomized to receive either CureXcell® or Placebo.

Enrollment: 252 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ankle Brachial Pressure Index (ABI) ≥ 0.80
• Venous insufficiency confirmed by duplex Doppler ultrasound
• Presence of a venous leg ulcer, unresponsive to Standard of Care treatment for at least 4 weeks and between ≥ 1 cm2 and ≤ 17.1 cm2 at screening; and between ≥ 1 cm2 and ≤ 12cm2 at the Baseline Visit

Exclusion criteria

• Target Ulcer has decreased >30% in size from Screening to Baseline
• Documented history of osteomyelitis at the Target Ulcer location within 6 months preceding the Baseline Visit.
• Patients who are unable to tolerate multi-layer compression therapy.
• Ulcer, which in the opinion of the Investigator is suspicious for cancer.
• Any malignancy within the past 5 years, excluding successfully treated basal cell carcinoma or squamous cell carcinoma without evidence of metastases.
• History of radiation at the Target Ulcer site in previous 12 months prior to Baseline Visit.
• Patients with clinically significant claudication
• Current sepsis
• Patients with known history of significantly compromised immunity for any reason including radiation therapy, chemotherapy or HIV

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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252 participants in 2 patient groups, including a placebo group

CureXcell®

Experimental group

Description:

CureXcell® injection will be administered about every 4 weeks for up to 3 treatments, or until ulcer closure, whichever occurs first.

Treatment:

Biological: CureXcell®

Placebo injection

Placebo Comparator group

Description:

The placebo will be administered by injecting normal saline at each centimeter of the ulcer bed.

Treatment:

Other: Placebo injection