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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
252
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.
Normal saline injected at each centimeter of ulcer bed
Unnamed facility
Mesa, Arizona, United States
Unnamed facility
Phoenix, Arizona, United States
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.
Time frame: up to 16 weeks
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.
Time frame: 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.
Time frame: up to 12 weeks
Proportion of Target Ulcer recurrence
Proportion of Target Ulcer recurrence during the 12-week Follow-Up Phase.
Time frame: up to 24 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Carlsbad, California, United States
Unnamed facility
Castro Valley, California, United States
Unnamed facility
Fresno, California, United States
Unnamed facility
Laguna Hills, California, United States
Unnamed facility
Los Angeles, California, United States
Unnamed facility
San Francisco, California, United States
Unnamed facility
Sylmar, California, United States
Unnamed facility
Hialeah, Florida, United States
...and 18 more locations