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

NCT05595681 | Terminated Phase 1

• 1 other identifier: STEMFOOT Pilot study
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mesenchymal Stromal Cells; Diabetic Foot Ulcer

Keywords

Healing Ulcer; Complications

Outcome Measures

Primary Outcomes (1)

• Time to complete ulcer healing

  Complete ulcer healing is defined as complete skin re-epithelialization without drainage or dressing requirements after removal of callus, confirmed at two consecutive study visits two weeks apart, and the time encountered as healed is the first of the two visits.

  12 weeks

Secondary Outcomes (1)

• Amount of index ulcers completely healed

  12 weeks

Other Outcomes (1)

• Other endpoints

  12 weeks

Study Arms (2)

Treatment group

EXPERIMENTAL

20 x 1000000 C2C\_ASCs on top of standard care.

Drug: Adipose tissue derived mesenchymal stromal/stem cells (Cell2Cure®)

Control group

NO INTERVENTION

Control group with standard care.

Interventions

Adipose tissue derived mesenchymal stromal/stem cells (Cell2Cure®) DRUG

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.

Treatment group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Likely inability yo comply with the need for clinical visits because of planned activity.

Sponsors & Collaborators

• Cell to Cure ApS: lead

Study Sites (1)

Copenhagen Diabetes Foot Center (CODIF)

Copenhagen, Denmark

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Jens Kastrup

  Cell to Cure ApS

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single center randomized open phase I clinical intervention

Study Record Dates

• First Submitted: September 23, 2022
• First Posted: October 27, 2022
• Study Start: December 15, 2022
• Primary Completion: November 28, 2025
• Study Completion: November 28, 2025
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

DK (1)