Using stem cells to heal foot ulcers in diabetes patients

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

This study is testing if injecting stem cells into diabetic foot ulcers can help them heal faster compared to just standard care alone.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 40 Years to 75 Years
• Sex: All
• Sponsor: Cell2Cure ApS (industry)
• Locations: 1 site (Copenhagen)
• Trial ID: NCT05595681 on ClinicalTrials.gov

What this trial studies

The STEMFOOT Pilot Study is a phase I clinical intervention trial that investigates the effects of allogenic adipose-derived mesenchymal stromal cells (C2C_ASC) on the healing of diabetic foot ulcers. Conducted at the Copenhagen Diabetes Foot Center, the study will enroll 30 adult diabetes patients with foot ulcers, randomly assigning them to receive either C2C_ASC treatment alongside standard care or standard care alone. The treatment involves injecting stem cells around the wound to promote healing while maintaining optimal management of the ulcer. The primary goal is to assess the time to healing and complications associated with the treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40-75 with diabetes and a specific type of foot ulcer meeting the study criteria.

Not a fit: Patients with infected ulcers, vascular insufficiency, or ulcers not related to diabetes may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve healing times and reduce complications for patients with diabetic foot ulcers.

How similar studies have performed: While the use of stem cells in wound healing is a novel approach, similar studies have shown promising results in other contexts, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

* Diagnosis of diabetes mellitus for at least 3 months.
* Age 40-75 years.
* A foot ulcer below the level of the malleoli, excluding ulcers confined to the digits or interdigital cleft. If more than one ulcer, the largest will be selected at screening as the index ulcer.
* Wound area after sharp debridement of ≥ 50 mm\^2, but ≤1000 mm\^2.

Exclusion Criteria:

* Signs of infection of the index ulcer.
* An ulcer where a probe investigation indicates ulcer depth to the underlying bone.
* Wound caused primarily by untreated vascular insufficiency, or where participants are primarily eligible for vascular intervention to promote wound healing.
* Wounds with an etiology not related to diabetes.
* Underlying osteomyelitis of the leg with the wound to be treated.
* Participants 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).
* Surgery to lengthen achilles tendon on the leg with the wound to be treated 3 months prioer to signing the informed consent form.
* Necrosis, purulence, or sinus tracts that cannon be removed by debridement on foot to be treated.
* Toe blood pressure \< 44 mmHg at the foot with the index ulcer.
* Dialysis or an estimated glomerular filtration rate (GFR) (based on serum creatinine) \< 20 ml/min/1.73 m\^2.
* Current treatment with cytotoxic drugs.
* Hospitalisation for a major cardiovascular event or procedure or revascularization surgery on a leg in the last 3 months or scheduled major cardiovascular intervention.
* Abuse of alcohol or drugs, or presence of any condition that in the Investigators opinion may lead to poor adherence to study protocol.
* Recent use (\< 3 months) of an investigational drug or participation in interventional clinical foot ulcer-healing trial.
* Females capable of becoming pregnant must have a negative pregnancy test prior to transplantation. After inclusion, they must use contraceptives for 12 weeks following the given stem cell treatment. The pill, spirak, depot injection of progesterone, sub-dermal implantation, hormonal vaginal ring and transdermal patch regarded as safe contraceptives.
* Likely inability yo comply with the need for clinical visits because of planned activity.
* Mental incapacity, unwillingness, or language barrier precluding adequate understanding or cooperation.
* Unable to provide written and signed informed consent.
* Any clinically significant disease or disorder, except for conditions associated to the type 1 or 2 diabetes, which in the Investigator's opinion could interfere with the results of the trial.
* Active cancer or a history of cancer in the 5 years prior to signing the informed consent form (history of basal cell carcinoma is allowed).
* Life expectancy of less than 12 months.

Where this trial is running

Copenhagen

• Copenhagen Diabetes Foot Center (CODIF) — Copenhagen, Denmark (RECRUITING)

Study contacts

• Study coordinator: Jens Kastrup

Conditions: Diabetic Foot Ulcer, Mesenchymal Stromal Cells, Healing Ulcer, Complications