PHASE 1, OPEN-LABEL SAFETY STUDY OF UMBILICAL CORD LINING MESENCHYMAL STEM CELLS (CORLICYTE®) TO HEAL CHRONIC DIABETIC FOOT ULCERS

Inclusion criteria

Inclusion criteria

• Males or non-pregnant, non-lactating females.
• Age 18 or greater at the time of informed consent.
• Able and willing to provide written informed consent.
• Type 1 or Type 2 diabetes.
• Chronic DFU as the index ulcer meeting all of the following criteria:

• present for at least 4 weeks at the time of Screening Visit 1
• located below the malleoli of the foot
• extends to the dermis or subcutaneous tissue, surrounded by healthy skin, without evidence of exposed muscle, tendon, bone, or joint capsule
• area measures 1 to 10 cm2 inclusive, at Screening Visit 1, and
• non-healing (defined as ≤50% reduction in ulcer size by the Baseline Visit, as compared to Screening Visit 1).
• Negative for antibodies to HLA Class I molecules expressed on Corlicyte MSCs, as measured by Luminex HLA single antigen beads, within 3 months prior to start of Treatment Phase without interval sensitizing events.
• For an index ulcer on the plantar surface of the foot, willingness to offload the foot per study protocol.
• In women of childbearing potential, willingness to use effective means of birth control during the course of the study; if using systemic birth control, this must have been used for 6 months or longer prior to Screening Visit 1.

Exclusion criteria

Exclusion criteria

• Planned DFU treatment to the index ulcer that includes enzymatic agents, cytotoxic agents or any substance(s) that would affect MSC survival during the study period.
• Women planning to become pregnant during the course of the study.
• Significant history of, or current evidence of a severe comorbid medical or psychiatric condition such as liver disease, end-stage renal disease, untreated proliferative retinopathy, bleeding diathesis, schizophrenia, or laboratory abnormality that, in the opinion of the Investigator, would preclude enrollment because of unacceptable risk.
• Presence of any skin condition or skin disorder around the index ulcer that might interfere with the diagnosis of or assessment of study-related endpoints, such as atopic dermatitis, eczema, psoriasis, or seborrheic dermatitis.
• Presence of actinic keratosis or skin cancer within 2 cm of the index ulcer.
• Cellulitis or other active infection of the index ulcer or any non-index ulcer at Screening.
• Use of an investigational agent for ulcer care within 30 days prior to Screening Visit 1.
• Receipt of an investigational agent or device not approved by the US FDA for marketed use in any indication within 30 days prior to Screening Visit 1.
• Planned participation in another therapeutic study for any indication prior to completion of study participation.
• Unwillingness or inability to comply with study visits and study procedures for the entire duration of study participation.
• Known positivity for Human Immunodeficiency Virus (HIV).
• Active osteomyelitis or gangrene of either foot at Screening.
• Known Methicillin-resistant Staphylococcus aureus (MRSA) infection within 30 days prior to Screening Visit 1.
• Poorly-controlled diabetes mellitus, defined as hemoglobin A1c (HbA1c) >12%.
• Unsuitable for cellular therapy for any reason, in the opinion of the Investigator.
• Planned use of cell therapy or amniotic membrane treatment for the index ulcer during study participation.
• Significant titer of antibodies to HLA Class I molecules expressed on Corlicyte MSCs, as measured by Luminex HLA single antigen beads.
• Presence of severe peripheral artery disease (PAD) defined as clinical evidence of critical limb ischemia (CLI) during Screening.