Patients with non-healing neuroischaemic diabetic foot wounds MedDRA version: 19.0 Level: LLT Classification code 10012664 Term: Diabetic foot ulcer System Organ Class: 100000004858
Conditions
Interventions
Product Name: REDDSTAR ORBCEL-M
Pharmaceutical Form: Cutaneous suspension
INN or Proposed INN: REDDSTAR ORBCEL-M
Other descriptive name: EX VIVO CULTURED HUMAN MESENCHYMAL STEM CELLS
Concentration uni
Sponsors
Steno Diabetes Center A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18-80 years. 2. Type 1 or Type 2 diabetes mellitus (with any kind or combination of pharmacological treatment for disease and/or complications to disease). 3. HbA1c = 97 mmol/mol (= 11%). 4. Males or non-pregnant females. 5. Understand trial information document. 6. Provide written informed consent. 7. Duration of (diabetic foot) wound > 4 but =65 years) yes F.1.3.1 Number of subjects for this age range 3
Exclusion criteria
Exclusion criteria: 1. Life expectancy of less than 12 months. 2. Patients with a definite diagnosis of any immunodeficiency disorder. 3. Viral hepatitis [patient must have negative hepatitis B surface-antigen (HBsAg) and hepatitis C antibody (HepCAb) test results obtained within 2 weeks prior to the Treatment Day (Day 1)]. 4. Active, uncontrolled connective tissue disease. 5. Renal failure as defined by serum creatinine > 220 µmol/L. 6. Liver function tests (e.g. AST, ALT) that are > 2.0 times ULN. 7. Poor nutritional status as measured by serum albumin 11% (>97 mmol/mol) documented at the screening visit. 17. Wounds caused primarily by untreated vascular insufficiency, or where patients are primarily eligible for vascular intervention to promote wound healing. 18. Wounds with an aetiology not related to diabetes. 19. More than three wounds on the target lower extremity. 20. The wound to be studied not anatomically distinct from another wound(s) (separated by 50% during the screening 4-week run-in period. 22. Ulcers with underlying osteomyelitis on the leg with the wound to be treated. 23. Patients presenting with the clinical characteristics of cellulitis at the wound site (suppurative inflammation involving particularly the subcutaneous tissue, often mild erythema, tenderness, malaise, chills and fever). 24. Revascularization surgery on the leg with the wound to be treated =8 weeks prior to signing the informed consent form. 25. Surgery to lengthen Achilles tendon on the leg with the wound to be treated =8 weeks prior to signing the informed consent form. 26. Necrosis, purulence, or sinus tracts that cannot be removed by debridement on foot to be treated. 27. Received dermal substitute or living skin equivalent (Leukopatch within 30 days prior to signing the informed consent form. 28. Received prior PDGF-BB (Regranex®/becaplermin) therapy within 30 days prior to
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the feasibility and safety of topically administered allogeneic bone marrow-derived mesenchymal stromal cells (REDDSTAR ORBCEL-M) seeded in a collagen scaffold to patients with non-healing neuroischaemic diabetic foot wounds.;Secondary Objective: Not applicable;Primary end point(s): Number and severity of serious adverse events considered related to treatment with study drug (mesenchymal stromal cells; REDDSTAR ORBCEL-M) ;Timepoint(s) of evaluation of this end point: From time of application of mesenchymal stromal cells until end of study visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety: Adverse events (serious or non-serious). Efficacy: a) Ulcer healing trajectories over time as assessed by plots of percentages of ulcer closure versus assessment of time. b) Time to complete ulcer closure (as defined as Treatment Day 1 to the first visit when closure is documented). c) Absolute and percent changes in ulcer area from baseline at weekly intervals through Week 12. d) Durability of ulcer closure as measured at 4 week intervals for 12 weeks from date of ulcer closure.;Timepoint(s) of evaluation of this end point: Safety: From time of application of mesenchymal stromal cells until end of study visit. Efficacy: a) From time of application of mesenchymal stromal cells until 12 weeks after (or until ulcer closure), measured at weekly intervals. b) From time of application of mesenchymal stromal cells until ulcer closure, measured at weekly intervals. c) From time of application of mesenchymal stromal cells until 12 weeks after (or until ulcer closure), measured at weekly intervals. d) From time of ulcer closure until 12 weeks after (or until re-opening of ulcer), measured at 4 week intervals. | — |
Countries
Denmark
Contacts
Public ContactStudy Coordinator
DanTrials ApS
Outcome results
None listed