Diabetic Foot UlcerPhase 1STEMFOOTNCT05595681
Effect of Mesenchymal Stem Cells on Healing of Foot Ulcers in Diabetes Patients.
A Phase 1 study testing Adipose tissue derived mesenchymal stromal/stem cells (Cell2Cure®) in people with Diabetic Foot Ulcer and Mesenchymal Stromal Cells, run by Cell to Cure ApS at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Diabetic Foot Ulcer, Mesenchymal Stromal Cells
- What is being tested?
- Adipose tissue derived mesenchymal stromal/stem cells (Cell2Cure®)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Dec 2022to 28 Nov 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Mesenchymal Stem Cells on Healing of Foot Ulcers in Diabetes Patients. A Phase I Pilot Study.
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.
Read the 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
- Being tested
- Adipose tissue derived mesenchymal stromal/stem cells (Cell2Cure®)
- Keywords
- Healing Ulcer, Complications
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | 20 x 1000000 C2C_ASCs on top of standard care. Receives: Drug: Adipose tissue derived mesenchymal stromal/stem cells (Cell2Cure®) |
| Control group | No intervention | Control group with standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (1)
Amount of index ulcers completely healed
Change in ulcer area at week 12
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start15 Dec 2022
- Primary completion28 Nov 2025
- Study completion28 Nov 2025
Why it stopped: Difficulties in enrolling trial subjects within in- and exclusion criteria, despite the trial period having been extended several times.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single center randomized open phase I clinical intervention
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cell to Cure ApS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jens Kastrup, Study director, Cell to Cure ApS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05595681
- Sponsor's protocol ID
- STEMFOOT Pilot study
- Acronym
- STEMFOOT
- Status last verified
- Dec 2025
- First submitted
- 23 Sep 2022
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mesenchymal Stem Cells on Healing of Foot Ulcers in Diabetes Patients. A Phase I Pilot Study.
- ClinicalTrials.gov ID
- NCT05595681
- Acronym / sponsor ID
- STEMFOOT / STEMFOOT Pilot study
- Conditions
- Diabetic Foot Ulcer, Mesenchymal Stromal Cells
- Keywords
- Healing Ulcer, Complications
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties in enrolling trial subjects within in- and exclusion criteria, despite the trial period having been extended several times.
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Cell to Cure ApSIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 28 Nov 2025 (actual)
- Study completion
- 28 Nov 2025 (actual)
- First posted
- 27 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single center randomized open phase I clinical intervention
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Adipose tissue derived mesenchymal stromal/stem cells (Cell2Cure®)20 x 1000000 C2C_ASCs on top of standard care. |
| Control group | No intervention | –Control group with standard care. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Treatment group |
Primary outcome
Time to complete ulcer healing
Time frame: 12 weeks
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.
1 secondary outcome
Amount of index ulcers completely healed
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Difficulties in enrolling trial subjects within in- and exclusion criteria, despite the trial period having been extended several times.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens Kastrup study director
Cell to Cure ApS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Adipose tissue derived mesenchymal stromal/stem cells (Cell2Cure®) in people with Diabetic Foot Ulcer and Mesenchymal Stromal Cells, run by Cell to Cure ApS at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Difficulties in enrolling trial subjects within in- and exclusion criteria, despite the trial period having been extended several times.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to complete ulcer healing (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.