Study Status: COMPLETED
Recruit Status: COMPLETED
Study Type: INTERVENTIONAL
Official Title: Diabetic Foot: Treatment of Chronic Ulcers and Neuropathy With Transplantation of Placenta Derived Stem Cells (PDSC) - A Dose Escalation Safety and Exploratory Efficacy Study
Brief Summary: This is an initial dose escalation safety and exploratory efficacy study to treat two groups of subjects with critically sized diabetic wounds and diabetic neuropathy using placental-derived stem cells (PDSC) transplanted by injection into soft tissues of the lower limb.
Its primary objective is safety assessment and its secondary objective is determining optimum PDSC safe dose.
Group 1 will receive implantation of cells in the ulcer, in the ulcer bed, and along the distal arterial vessels that supply blood to the foot.
Group 2 will follow the same protocol for the foot but will have an additional dose of cells implanted in the anterior and posterior compartments of the same leg to determine the impact on peripheral neuropathy.
Dose escalation and safety will be documented.
Exploratory measures of efficacy include: ulcer healing, hemodynamic and anatomical effects on the arteries of the foot, and changes in the sensory perceptions of the foot.