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

Inclusion Criteria:

1. Adults at least 18 years of age up to 80 years of age, inclusive.

2. Have a current diagnosis of diabetes mellitus (DM)

3. With at least one non-healing cutaneous ulcer on the foot or the lower legs

4. With ankle brachial index (ABI) ≥ 0.4 and/or toe pressure >30 mmHg on the limb withthe study ulcer.

5. Participant co-morbidities are adequately managed, and the participant has a lifeexpectancy of at least 6 months as determined by the Investigator based on medicalhistory, physical examination, vital signs, or clinical laboratory tests, etc.

6. A negative pregnancy test, (i.e. for female participants with childbearingpotential).

7. Willing to comply with birth control measures, to prevent female participantsbecoming pregnant for six months following administration of the study treatment.

8. Able to follow the Investigator's instruction on ulcer care (in the opinion of theInvestigator).

9. Agrees to provide written informed consent.

Exclusion Criteria:

1. Planned vascular surgery, angioplasty, thrombolysis or amputation of the affectedlimb in the next six months.

2. Pregnant or breastfeeding.

3. Active infection in the study ulcer.

4. Any sign of osteomyelitis associated with the study ulcer.

5. Study ulcer extends to bone or periosteum (ulcers that reach a ligament, jointcapsule, fascia, or tendon are not excluded).

6. Study ulcer requires daily dressing changes.

7. Known autoimmune disease other than diabetes, including but not limited to lupuserythematosus, multiple sclerosis which are considered as clinically significant byPI and/or Medical Monitor.

8. Treatment with systemic immunosuppressants within 90 days of screening.

9. 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).

10. Serum GGT, AST or ALT > 5 × upper limit of the normal range (ULN).

11. . Known history of HIV infection

12. Prior administration of any cell-based treatment to the limb affected by the studyulcer.

13. Received any investigational research agent within 60 days or within five half-livesof the last treatment (if the half-life of the investigational agent is known to belonger than 12 days) prior to the planned initiation of study treatment.

14. Any other medical condition or laboratory abnormality judged as clinicallysignificant by the Investigator or study Medical Monitor which could confound theevaluation of the trial treatment.

15. With history of sensitivity to materials of bovine, porcine origin, or human serumalbumin.