Safety, Tolerability and Efficacy of CYP-006TK in Adults with Diabetic Foot Ulcers

Inclusion criteria

• Adults at least 18 years of age up to 80 years of age, inclusive.
• Have a current diagnosis of diabetes mellitus (DM)
• With at least one non-healing cutaneous ulcer on the foot or the lower legs
• With ankle brachial index (ABI) ≥ 0.4 and/or toe pressure >30 mmHg on the limb with the study ulcer.
• Participant co-morbidities are adequately managed, and the participant has a life expectancy of at least 6 months as determined by the Investigator based on medical history, physical examination, vital signs, or clinical laboratory tests, etc.
• A negative pregnancy test, (i.e. for female participants with childbearing potential).
• Willing to comply with birth control measures, to prevent female participants becoming pregnant for six months following administration of the study treatment.
• Able to follow the Investigator's instruction on ulcer care (in the opinion of the Investigator).
• Agrees to provide written informed consent.

Exclusion criteria

• Planned vascular surgery, angioplasty, thrombolysis or amputation of the affected limb in the next six months.
• Pregnant or breastfeeding.
• Active infection in the study ulcer.
• Any sign of osteomyelitis associated with the study ulcer.
• Study ulcer extends to bone or periosteum (ulcers that reach a ligament, joint capsule, fascia, or tendon are not excluded).
• Study ulcer requires daily dressing changes.
• Known autoimmune disease other than diabetes, including but not limited to lupus erythematosus, multiple sclerosis which are considered as clinically significant by PI and/or Medical Monitor.
• Treatment with systemic immunosuppressants within 90 days of screening.
• Active malignancy or history of malignancy within five years prior to screening (with the exception of a past history of basal or squamous cell carcinomas).
• Serum GGT, AST or ALT > 5 × upper limit of the normal range (ULN).
• . Known history of HIV infection
• Prior administration of any cell-based treatment to the limb affected by the study ulcer.
• Received any investigational research agent within 60 days or within five half-lives of the last treatment (if the half-life of the investigational agent is known to be longer than 12 days) prior to the planned initiation of study treatment.
• Any other medical condition or laboratory abnormality judged as clinically significant by the Investigator or study Medical Monitor which could confound the evaluation of the trial treatment.
• With history of sensitivity to materials of bovine, porcine origin, or human serum albumin.