NCT03509870

Bone Marrow Derived Allogeneic Mesenchymal Stromal Cells to Non-healing Diabetic Foot Wounds

Uncontrolled Non-randomised Single Dose Study of Topically Applied Bone Marrow Derived Allogeneic Mesenchymal Stromal Cells (REDDSTAR (ORBCEL-M)) in Patients With Non-healing Neuroischaemic Diabetic Foot Wounds'

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Steno Diabetes Center Copenhagen · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

examine safety of topical application of single dose allogeneic bone marrow derived mesenchymal stromal cells to non-healing diabetic foot ulcers

Detailed description

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.

Conditions

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
BIOLOGICAL	mesenchymal stromal cells	mesenchymal stromal cells in a collagen scaffold

Timeline

• Start date: 2018-06-01
• Primary completion: 2020-04-01
• Completion: 2020-04-01
• First posted: 2018-04-26
• Last updated: 2020-08-19

Locations

1 site across 1 country: Denmark