Evaluation of CureXcell® in Treating Chronic Venous Leg Ulcers

Chronic Venous Leg Ulcers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02130310
• Other study ID #: MC-105
• Status: Active, not recruiting
• Phase: Phase 3
• First received: May 1, 2014
• Last updated: September 22, 2015
• Start date: May 2014
• Est. completion date: June 2016

Study information

• Verified date: September 2015
• Source: Macrocure Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 252
• Est. completion date: June 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Venous Leg Ulcers
• Leg Ulcer
• Ulcer
• Varicose Ulcer

Intervention

Biological:
• CureXcell®
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.

Other:
• Placebo injection
Normal saline injected at each centimeter of ulcer bed

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Macrocure Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse Events	Incidence of adverse events, including overall AEs, AEs related to the CureXcell® and study-ulcer-associated AEs.	up to 24 weeks	Yes
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Proportion of Target Ulcer recurrence	Proportion of Target Ulcer recurrence during the 12-week Follow-Up Phase.	up to 24 weeks	No