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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05595681
Study type	Interventional
Source	Cell2Cure ApS
Contact	Jens Kastrup
Phone	+4521202994
Email	jk@cell2cure.com
Status	Recruiting
Phase	Phase 1
Start date	December 15, 2022
Completion date	November 1, 2025

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms