Evaluation of CureXcell® in Treating Chronic Venous Leg Ulcers

Study Overview
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Brief Summary
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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.

Official Title
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A Phase-3 Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of CureXcell® as an Adjunct to Good Ulcer Care Measures in Treating Chronic Venous Leg Ulcers

Conditions
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Chronic Venous Leg Ulcers

Intervention / Treatment
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* Biological: CureXcell®
* Other: Placebo injection


Participation Criteria
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Eligibility Criteria
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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

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CureXcell®<br>CureXcell® injection will be administered about every 4 weeks for up to 3 treatments, or until ulcer closure, whichever occurs first. | Biological: CureXcell®<br>* CureXcell® is a cell based therapy obtained from donated whole blood. The blood is collected from healthy young adults, the white blood cells are separated and then activated by hypo-osmotic shock.<br>|
| Placebo Comparator: Placebo injection<br>The placebo will be administered by injecting normal saline at each centimeter of the ulcer bed. | Other: Placebo injection<br>* Normal saline injected at each centimeter of ulcer bed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to complete closure of Target Ulcer | Time to complete closure of Target Ulcer at any time during the 12-week Treatment Phase. Complete closure is confirmed at two consecutive study visits two weeks apart. | up to 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of complete closure of Target Ulcer | Proportion of complete closure of Target Ulcer within the Treatment Phase. Complete closure is confirmed at two consecutive study visits two weeks apart. | up to 16 weeks | 
| Percentage change from baseline in Target Ulcer surface area | Percentage change from baseline in Target Ulcer surface area at the end of the Treatment Phase. | up to 12 weeks | 
| Proportion of Target Ulcer recurrence | Proportion of Target Ulcer recurrence during the 12-week Follow-Up Phase. | up to 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic ulcers, Venous ulcers