Study for Treatment of Chronic Diabetic Foot Ulcers With the Investigational Allogeneic Cell Therapy Product, hOMSC200
Diabetic Foot, Diabetic Foot Ulcer, Diabetic Foot Ulcer Neuropathic
About this trial
This is an interventional treatment trial for Diabetic Foot focused on measuring diabetic foot ulcer, stem cells
Eligibility Criteria
Inclusion Criteria: Diagnosed with Type I or Type 2diabetes and with a neuropathic diabetic foot ulcer for longer than 8 weeks. Size of foot ulcer 0.5-13 cm2 Ulcer graded I by Wager scale Ulcer is free of necrotic debris, exhibits no signs of clinical infection Ulcer area blood circulation meets one of the following criteria: A. Palpable tibialis anterior and posterior arteries in the affected foot; B. ABI range >0.7 to <1.3; C. TcPO2>30mmHg Exclusion Criteria: Ulcer is of non-diabetic pathophysiology The ulcer has decreased in size by >=30% after the screening visit (week -2 to -4 before treatment) Severe hepatic deficiency Glycated hemoglobin A1C (HbA1C) level of >12% Postprandial blood sugar > 350mg/dl Require antibiotics to treat the target wound infection within 14 days prior to treatment Evidence of current wound infection including pus drainage from wound site Severe renal failure (GFR<30) including subject on renal dialysis Pregnant or breastfeeding Was receiving oral or parenteral corticosteroids, immunosuppressives, or cytotoxic agents prior to 4 weeks from screening Patient receiving anticoagulation therapy except for aspirin Underwent wound treatments with growth factors, dermal substitutes, or other biological therapies within the last 30 days prior to screening visit
Sites / Locations
- Shaare Zedek Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
Low dose hOMSC200
High dose hOMSC200
Placebo
Administration of low dose hOMSC200 in addition to routine standard of care
Administration of high dose hOMSC200 in addition to routine standard of care
Administration of placebo in addition to routine standard of care