1.1 Trial Phase~Phase 1b~1.2 Trial Aims and Objectives~To examine the safety of topical application of a single dose of allogeneic bone marrow derived mesenchymal stromal cells (REDDSTAR ORBCEL-M) seeded in a collagen scaffold to patients with non-healing neuroischaemic diabetic foot wounds.~1.3 Patient Population~Patients with non-healing neuroischaemic diabetic foot wounds despite standard care.~1.4 Trial Setting~Steno Diabetes Center Copenhagen, Denmark and Zelo Phase I Unit, Bispebjerg Hospital, Copenhagen, Denmark.~1.5 Trial Intervention~Topical application of allogeneic bone marrow derived mesenchymal stromal cells seeded in a collagen scaffold to patients with non-healing neuroischaemic diabetic foot wounds.~1.6 Concurrent Control~Open label, uncontrolled, non-randomised, single dose study.~1.7 Sample Size~9~1.8 Method of Participant Assignment~Administration of a single dose of allogeneic bone marrow-derived mesenchymal stromal cells seeded in a collagen scaffold.~1.9 Examination Points~0, 1 week, 2 weeks, 3 weeks, 4 weeks up until 12 weeks or until complete wound closure. After the week 12 visit, or ulcer closure, whichever occurs first, each patient will return to the clinic 1 (± 2 days), 2 (± 2 days), 4 (± 3 days), 8 (±3 days), and 12 (±3days) weeks later for follow-up visits to for adverse events, assess wound, wound closure and durability.~1.10 Primary Outcome~Serious adverse events that are attributable to intervention.~1.11 Secondary Outcomes~Time to complete wound closure (defined as from treatment day 1 to the first visit when closure is documented). Absolute and percent changes in wound area from baseline, at weekly intervals throughout. Durability of wound closure as measured at 4 week intervals for 12 weeks from date of wound closure.
examine safety of topical application of single dose allogeneic bone marrow derived mesenchymal stromal cells to non-healing diabetic foot ulcers