Clinical Trial: Placenta Derived Stem Cells for Treating of Chronic Ulcers and Neuropathy
Study Status: COMPLETED
Recruit Status: COMPLETED
Condition: Diabetic Foot
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…
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