Study for Treatment of Chronic Diabetic Foot Ulcers With the Investigational Allogeneic Cell Ther… (NCT06003530) | Clinical Trial Compass
UnknownPhase 1
Study for Treatment of Chronic Diabetic Foot Ulcers With the Investigational Allogeneic Cell Therapy Product, hOMSC200
Israel21 participantsStarted 2022-01-06
Plain-language summary
Purpose of this phase 1/2a study is to assess the safety and efficacy of administration of allogeneic human oral mucosal stem cells (hOMSCs) in patients suffering from chronic diabetic foot ulcers (DFU).
Who can participate
Age range18 Years – 80 Years
SexALL
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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