Evaluation of CureXcell® in Treating Chronic Venous Leg Ulcers

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02130310

Enrollment

252

Registered

2014-05-05

Start date

2014-05-31

Completion date

2016-06-30

Last updated

2015-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Venous Leg Ulcers

Keywords

Chronic ulcers, Venous ulcers

Brief 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.

Interventions

BIOLOGICALCureXcell®

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.

OTHERPlacebo injection

Normal saline injected at each centimeter of ulcer bed

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Time to complete closure of Target Ulcer	up to 16 weeks	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.

Secondary

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

Other

Measure	Time frame	Description
Adverse Events	up to 24 weeks	Incidence of adverse events, including overall AEs, AEs related to the CureXcell® and study-ulcer-associated AEs.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026