Status:
ACTIVE_NOT_RECRUITING
Study for Treatment of Chronic Diabetic Foot Ulcers With the Investigational Allogeneic Cell Therapy Product, hOMSC200
Lead Sponsor:
Cytora Ltd.
Conditions:
Diabetic Foot
Diabetic Foot Ulcer
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief 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 (DF...
Detailed Description
A prospective, placebo controlled, partially blinded and randomized study, comprising two hOMSC200 dose groups (low \& high) and one placebo treated group of DFU patients (3 groups; n=8 / treatment gr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT06003530
Start Date
January 6 2022
End Date
December 31 2024
Last Update
March 13 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Shaare Zedek Medical Center
Jerusalem, Israel, 9103102