NCT05595681

Effect of Mesenchymal Stem Cells on Healing of Foot Ulcers in Diabetes Patients.

Effect of Mesenchymal Stem Cells on Healing of Foot Ulcers in Diabetes Patients. A Phase I Pilot Study.

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Cell to Cure ApS · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The STEMFOOT Pilot Study is a single center randomized open phase I clinical intervention pilot trial with the aim of investigating the treatment effect of an allogenic adipose-derived mesenchymal stromal cell product (C2C\_ASC) compared to conventional optimal treatment on healing and complications of foot ulcers in diabetes patients.

Detailed description

The STEMFOOT Pilot Study will be performed at Copenhagen Diabetes Foot Center, Department of Endocrinology, Bispebjerg Hospital, Denmark. 30 adult patients with diabetes and foot ulcer will be enrolled and randomly assigned 1:1 to either C2C\_ASC treatment on top of standard care (n=15) or control group with standard care (n=15). C2C\_ASC treatment: 1 ml containing 20 x 106 C2C\_ASCs will be injected into the subcutaneous dermo-epidermal junction and homogenously around the wound (4 - 6 injections), but not directly within the index foot ulcer. The depth from the index wound border will be 0,5 - 1 cm into the subcutaneous tissue. Standard care: Each treatment will be administered in the context of independently-managed standard of care, including (a) formal assessment of the ulcer and surrounding skin at each clinic review; (b) provision of any necessary off-loading, with detailed description of the type and assessment of its effectiveness; (c) debridement of the wound surface, which can be surgical (either in the clinic or in an operating room) or non-surgical; (d) selection of appropriate dressing products, ensuring a moist ulcer environment; (e) management of ulcer infection; (f) attention to nutrition and self-care; (g) optimization of glycemic and risk factor control; (h) revascularization when appropriate and (i) continued close observation with appropriate adjustment of management. We hypothesize that in diabtes patients with foot ulcer, the time to healing is significantly shorter and more foot ulcers are completely healed at week 12 when treated with C2C\_ASC on top of standard care compared to control.

Conditions

• Diabetic Foot Ulcer
• Mesenchymal Stromal Cells

Interventions

Type	Name	Description
DRUG	Adipose tissue derived mesenchymal stromal/stem cells (Cell2Cure®)	The investigational product is a C2C\_ASC cell product (Cell2Cure®, Cell2Cure ApS, Denmark). C2C\_ASC is an advanced therapy investigational medicinal product (ATIMP) manufactured from abdominal adipose tissue derived mesenchymal stromal cells (ASC) from healthy donors. C2C\_ASC is aseptically procured and manufactured according to tissue law and GMP by Cell2Cure ApS or Cardiology Stem Cell Center, Rigshospitalet, Copenhagen, Denmark, using manual isolation of cells from abdominal fat tissue, xeno-free cell expansion in automated closed bioreactor systems and cryopreservation of the final product. The active substance is the in vitro expanded ASCs. The final product, C2C\_ASC, is provided as a cryopreserved suspension of 50 million ASCs per ml with a total volume of 1,3 ml per vial. The exipient is CryoStor10 (Biolife Solutions), holding 10% DMSO.

Timeline

• Start date: 2022-12-15
• Primary completion: 2025-11-28
• Completion: 2025-11-28
• First posted: 2022-10-27
• Last updated: 2025-12-23

Locations

1 site across 1 country: Denmark