The objective of this study is to make Dermacyte Liquid available on an expanded accessbasis to treat cutaneous ulcers and wounds refractory to initial treatment or that do nothave adequate alternative treatments. Minimal data will be collected to evaluate theefficacy and safety of Dermacyte Liquid.
The primary purpose is to provide expanded access of Dermacyte Liquid to subjects who
have serious cutaneous ulcers and wounds (e.g., ulcers related to diabetes mellitus,
venous insufficiency, complications of systemic sclerosis or rheumatic disease; decubitus
ulcers, burns, acute trauma, wound dehiscence, ischemic ulcers, and mixed etiology
ulcers). Eligible subjects must have a high likelihood of significant morbidity, loss of
quality of life, potential amputation, or mortality without efficacious treatment. As
there are many types of patients who may be enrolled, study results will not have
statistical significance.
Drug: MTX-001 (Dermacyte Liquid)
Repeat dose subcutaneous drug injection for the treatment of serious chronic wounds.
Inclusion Criteria:
- Must be 18 years of age or older
- Must have a cutaneous ulcer or wound refractory to initial treatment or does not
have an adequate treatment alternative, as determined by the Investigator
Exclusion Criteria:
- Must not be pregnant or lactating
- Must not have known malignancies
- Must not be less than 18 years of age
The WISH Clinic
Arvada, Colorado, United States
Sean O'Connell, PhD Scientic & Medical Affairs Scientist
973-214-0837
seano@merakris.com
Not Provided