Phase 1 Safety Trial of Placental Stem Cells (PLSC) to Accelerate the Healing of Diabetic Foot Ulcers
Wake Forest University Health Sciences
Summary
The purpose of this research study is to test the safety of placental stem cells to treat non-healing diabetic foot ulcers.
Description
This is a prospective, non-randomized, single institution, Phase 1 safety trial to evaluate the safety of placental stem cells and the rate of diabetic foot ulcer healing in a population of subjects with non-healing diabetic foot ulcers for at least 4 weeks. The trial will also explore the clinical outcomes of placental stem cells treatment on diabetic peripheral neuropathy. Furthermore, the trial will evaluate the effect of the placental stem cells on serum biomarkers associated with diabetic foot ulcers and diabetic peripheral neuropathy (measured pre- and post-treatment) and correlate the b…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Diagnosed with Type 2 Diabetes mellitus (DM) - for at least 1 year * Unilateral non-healing Diabetic Foot Ulcer (DFU) \> 2 cm2 and ≤ 4 cm2 (length × width) for at least four weeks despite Atrium Health Wake Forest Baptist standard of care treatment (which can include total contact cast, knee high air cast, and/or compression wrap) * No new diabetes medication for at least 2 weeks pre-treatment * Subjects must be willing to avoid steroids for the week prior to procedure day Exclusion Criteria: * Clinical signs of active infection requiring systemic antibiotic therapy le…
Interventions
- DrugPlacenta Stem Cells
Injection of 30 M placenta stem cells into/around the diabetic foot ulcer and along the anterior and posterior tibial arteries of the index leg.
Location
- Atrium Health Wake Forest BaptistWinston-Salem, North Carolina