Peripheral Arterial DiseasePhase 1/2NCT06326203
Cell Therapy for Lower Limb Ulcers in Patients With Critical Limb Ischemia
A Phase 1/2 study testing CELULAS TRONCO and CONVENTIONAL DRESSING in people with Peripheral Arterial Disease and Leg Ulcer, run by UPECLIN HC FM Botucatu Unesp.
Trial summary
Peripheral arterial disease (PAD) can progress to critical limb ischemia (CLI) of the affected lower limb, characterized by pain at rest, ulcerations or gangrene, with a high risk of amputation. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Peripheral Arterial Disease, Leg Ulcer
- What is being tested?
- CELULAS TRONCO and CONVENTIONAL DRESSING
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 31 Mar 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Absence of distal pulses in the leg (anterior tibial and posterior tibial) and presence or absence of popliteal pulse.
- Peripheral Arterial Disease (PAD).
- Having foot or leg ulcer(s) (distal third) with a minimum area of 1cm2 and a maximum of 3 ulcers totaling up to 20cm2 in the lower limb.
- Having previously received conventional dressing treatment for ulcer indicating no improvement over a minimum period of 3 weeks (antibiotic therapy - if necessary - local care such as mechanical, surgical or chemical debridements - if necessary, dressings).
- PAD with IC classified as Fontaine IV and Rutherford 5.
- Having Ankle Brachial Index (ABI) <0.9 in infragenicular arteries (anterior tibial, posterior tibial, and fibular) or ABI>1.3 in one or more infragenicular arteries when suffering from chronic DMT2 (disease duration > 5 years) not subjected to revascularization treatment or subjected to partial revascularization treatment or treatment failure (stenosis or occlusion) in the last 12 months.
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- Inability to revascularize the affected limb (do not have visible infragenicular arteries for surgical approach) and or incomplete revascularization of this limb (undergone endovascular and or surgical treatment that was not able to restore infragenicular pulses) and defined by the doctor that the best available treatment from the surgical vascular point of view has already been performed and was not successful in promoting ulcer healing.
- Drug treatment for PAD and for comorbidities.
- Availability to attend medical appointments.
Who cannot join
- Being pregnant or in the puerperium.
- Having a healed ulcer during the screening period.
- Having signs of systemic infection or active infection in the arterial ulcer or infection of surgical prostheses (bypass, pins, screws). They may be eligible again if they have been successfully treated with antibiotics and the infectious focus has been removed.
- Having an ulcer with devitalized tissue (necrosis). They may be eligible again if they have undergone successful surgical debridement or minor amputations (amputation of toes or limited to the forefoot).
- Having neoplasia and/or being in chemotherapy or radiotherapy treatment or in remission for less than 6 months.
- Being on colchicine or immunomodulators.
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- Having infectious diseases such as Human Immunodeficiency Virus (HIV), Hepatitis B and C viruses, Human T-cell Lymphotropic Virus (HTLV); due to the risk of contagion during the manipulation of biological material in the laboratory.
- Having undergone amputation at the level of the leg or thigh in the limb intended to be studied.
- Having COVID-19, diagnosed less than 4 weeks ago.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Lenize S Rodrigues, Ph.D. contact
About this study
Official title: Randomized, Prospective, Controlled, Single-center, Open-label Phase II Clinical Trial Aimed at Evaluating the Safety and Efficacy of Autologous Mesenchymal Stem Cell Therapy for Lower Limb Ulcers in Patients With Critical Limb Ischemia
Peripheral arterial disease (PAD) can progress to critical limb ischemia (CLI) of the affected lower limb, characterized by pain at rest, ulcerations or gangrene, with a high risk of amputation. In this phase, the best treatment is arterial limb revascularization, but this is not always possible or even effective for promoting pain relief, healing of ulcers or preventing amputations, in addition to the high socioeconomic cost caused by the disease. Recent advances in cell therapy represent a promising supporting alternative for the treatment of PAD in cases where conventional alternatives have run out. Objective: To evaluate the safety and efficacy of cell therapy with expanded autologous mesenchymal stem cells in the treatment of patients with PAD with CLI and chronic arterial ulcers. Methods: An open randomized clinical study will be performed with 2 groups of 20 patients with CLI: in group 1, a fragment of abdominal fat tissue (10g) will be collected to obtain mesenchymal stem cells, which will be expanded and applied using subcutaneous perilesional injection in the affected lower limb, in addition to the application in the form of a personalized curative biological on the wounds. Group 2 will receive conventional treatment with a Hydrogel dressing with essential fatty acids. Periodic clinical evaluations, complementary exams and photographic record will be carried out. The main outcome of effectiveness will be partial or total wound healing. Safety outcomes will be monitored for infections, gangrene, amputations and deaths. Participants will be monitored for 120 days. Major amputation cases will not be included. An independent external evaluator and blind to the groups will evaluate the results. It is an innovative procedure with high impact and financial return for SUS, in view of the high prevalence of the disease and the high socioeconomic impact of the disease when it progresses to limb amputation.
- Conditions
- Peripheral Arterial Disease, Leg Ulcer
- Being tested
- CELULAS TRONCO, CONVENTIONAL DRESSING
- Medical subject headings
- Peripheral Arterial Disease, Leg Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CELULAS TRONCOBiological
Cellular Therapy Treatment: The treatment will consist of **20 participants (n=20) who will receive treatment with expanded mesenchymal stem cells (MSCs). The patient will undergo a surgical debridement procedure for the ulcer to be in its optimal condition (Visit 1). Subsequently, the patient will receive MSC application via perilesional injections and a biocovering produced by the study team, also containing the same cells (single session - the MSC-containing dressing will remain in contact with the ulcer for 7 days). After removal of the biological dressing, the ulcer will receive local care with a topical hydrogel dressing, dry gauze, and a crepe bandage, with a minimum of one change per day.
CONVENTIONAL DRESSINGDevice
The control group will consist of 20 participants (n=20) who will receive local care for the ulcer. The patient will undergo a surgical debridement procedure for the ulcer to be in its optimal condition (Visit 1). Subsequently, the patient will receive the application of a conventional dressing with Hydrogel, dry gauze, and a crepe bandage. The patient will be instructed to change the dressing at least once a day.
| Study group | Role | What they receive |
|---|---|---|
| EMBRYONIC STEM CELLS | Experimental | Cellular Therapy Treatment: The treatment will consist of **20 participants (n=20) who will receive treatment with expanded mesenchymal stem cells (MSCs). The patient will undergo a surgical debridement procedure for the ulcer to be in its optimal condition (Visit 1). Subsequently, the patient will receive MSC application via perilesional injections and a biocovering produced by the study team, also containing the same cells (single session - the MSC-containing dressing will remain in contact with the ulcer for 7 days). After removal of the biological dressing, the ulcer will receive local care with a topical hydrogel dressing, dry gauze, and a crepe bandage, with a minimum of one change per day. Receives: Biological: CELULAS TRONCO |
| CONVENTIONAL DRESSING (Control Group) | Active comparator | The control group will consist of 20 participants (n=20) who will receive local care for the ulcer. The patient will undergo a surgical debridement procedure for the ulcer to be in its optimal condition (Visit 1). Subsequently, the patient will receive the application of a conventional dressing with Hydrogel, dry gauze, and a crepe bandage. The patient will be instructed to change the dressing at least once a day. Receives: Device: CONVENTIONAL DRESSING |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Amputation
Defined by total number of patients subjected to amputation at the knee or tight level.
Measured: 120 days
Ulcer Healing
Defined by total or partial epithelization of the ulcer as measured in total square centimeters.
Measured: 7, 30, 60, 90 and 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start1 Jun 2026 (estimated)
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UPECLIN HC FM Botucatu Unesp
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Matheus Bertanha, PhD, UPECLIN HC FM Botucatu Unesp
- Investigators
- Francisco J de Oliveira Filho, M.D., Principal investigator, São Paulo State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06326203
- Sponsor's protocol ID
- UPECLIN-MB-8
- Status last verified
- May 2026
- First submitted
- 16 Mar 2024
- Last updated
- 6 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Oliveira Filho FJ, Rodrigues LDS, Amaral SMBD, Mellucci Filho PL, Medolago NB, de Carvalho Bovolato AL, Alvarado RC, Bertanha M. Study protocol for a randomized clinical trial evaluating the safety and efficacy of autologous adipose-derived stem cell therapy for ulcers in patients with critical limb ischemia. PLoS One. 2025 Apr 9;20(4):e0318922. doi: 10.1371/journal.pone.0318922. eCollection 2025.
PubMed 40202953
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Prospective, Controlled, Single-center, Open-label Phase II Clinical Trial Aimed at Evaluating the Safety and Efficacy of Autologous Mesenchymal Stem Cell Therapy for Lower Limb Ulcers in Patients With Critical Limb Ischemia
- ClinicalTrials.gov ID
- NCT06326203
- Acronym / sponsor ID
- UPECLIN-MB-8
- Conditions
- Peripheral Arterial Disease, Leg Ulcer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- UPECLIN HC FM Botucatu UnespUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 22 Mar 2024 (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.
Peripheral arterial disease (PAD) can progress to critical limb ischemia (CLI) of the affected lower limb, characterized by pain at rest, ulcerations or gangrene, with a high risk of amputation. In this phase, the best treatment is arterial limb revascularization, but this is not always possible or even effective for promoting pain relief, healing of ulcers or preventing amputations, in addition to the high socioeconomic cost caused by the disease. Recent advances in cell therapy represent a promising supporting alternative for the treatment of PAD in cases where conventional alternatives have run out. Objective: To evaluate the safety and efficacy of cell therapy with expanded autologous mesenchymal stem cells in the treatment of patients with PAD with CLI and chronic arterial ulcers. Methods: An open randomized clinical study will be performed with 2 groups of 20 patients with CLI: in group 1, a fragment of abdominal fat tissue (10g) will be collected to obtain mesenchymal stem cells, which will be expanded and applied using subcutaneous perilesional injection in the affected lower limb, in addition to the application in the form of a personalized curative biological on the wounds. Group 2 will receive conventional treatment with a Hydrogel dressing with essential fatty acids. Periodic clinical evaluations, complementary exams and photographic record will be carried out. The main outcome of effectiveness will be partial or total wound healing. Safety outcomes will be monitored for infections, gangrene, amputations and deaths. Participants will be monitored for 120 days. Major amputation cases will not be included. An independent external evaluator and blind to the groups will evaluate the results. It is an innovative procedure with high impact and financial return for SUS, in view of the high prevalence of the disease and the high socioeconomic impact of the disease when it progresses to limb amputation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EMBRYONIC STEM CELLS | Experimental | Biological: CELULAS TRONCOCellular Therapy Treatment: The treatment will consist of **20 participants (n=20) who will receive treatment with expanded mesenchymal stem cells (MSCs). The patient will undergo a surgical debridement procedure for the ulcer to be in its optimal condition (Visit 1). Subsequently, the patient will receive MSC application via perilesional injections and a biocovering produced by the study team, also containing the same cells (single session - the MSC-containing dressing will remain in contact with the ulcer for 7 days). After removal of the biological dressing, the ulcer will receive local care with a topical hydrogel dressing, dry gauze, and a crepe bandage, with a minimum of one change per day. |
| CONVENTIONAL DRESSING (Control Group) | Active comparator | Device: CONVENTIONAL DRESSINGThe control group will consist of 20 participants (n=20) who will receive local care for the ulcer. The patient will undergo a surgical debridement procedure for the ulcer to be in its optimal condition (Visit 1). Subsequently, the patient will receive the application of a conventional dressing with Hydrogel, dry gauze, and a crepe bandage. The patient will be instructed to change the dressing at least once a day. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Absence of distal pulses in the leg (anterior tibial and posterior tibial) and presence or absence of popliteal pulse.
- Peripheral Arterial Disease (PAD).
- Having foot or leg ulcer(s) (distal third) with a minimum area of 1cm2 and a maximum of 3 ulcers totaling up to 20cm2 in the lower limb.
- Having previously received conventional dressing treatment for ulcer indicating no improvement over a minimum period of 3 weeks (antibiotic therapy - if necessary - local care such as mechanical, surgical or chemical debridements - if necessary, dressings).
- PAD with IC classified as Fontaine IV and Rutherford 5.
Key exclusion criteria (9 listed)
- Being pregnant or in the puerperium.
- Having a healed ulcer during the screening period.
- Having signs of systemic infection or active infection in the arterial ulcer or infection of surgical prostheses (bypass, pins, screws). They may be eligible again if they have been successfully treated with antibiotics and the infectious focus has been removed.
- Having an ulcer with devitalized tissue (necrosis). They may be eligible again if they have undergone successful surgical debridement or minor amputations (amputation of toes or limited to the forefoot).
- Having neoplasia and/or being in chemotherapy or radiotherapy treatment or in remission for less than 6 months.
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 |
|---|---|---|
| CELULAS TRONCOCellular Therapy Treatment: The treatment will consist of **20 participants (n=20) who will receive treatment with expanded mesenchymal stem cells (MSCs). The patient will undergo a surgical debridement procedure for the ulcer to be in its optimal condition (Visit 1). Subsequently, the patient will receive MSC application via perilesional injections and a biocovering produced by the study team, also containing the same cells (single session - the MSC-containing dressing will remain in contact with the ulcer for 7 days). After removal of the biological dressing, the ulcer will receive local care with a topical hydrogel dressing, dry gauze, and a crepe bandage, with a minimum of one change per day. | Biological | EMBRYONIC STEM CELLS |
| CONVENTIONAL DRESSINGThe control group will consist of 20 participants (n=20) who will receive local care for the ulcer. The patient will undergo a surgical debridement procedure for the ulcer to be in its optimal condition (Visit 1). Subsequently, the patient will receive the application of a conventional dressing with Hydrogel, dry gauze, and a crepe bandage. The patient will be instructed to change the dressing at least once a day. | Device | CONVENTIONAL DRESSING (Control Group) |
Primary outcome
Major Amputation
Time frame: 120 days
Defined by total number of patients subjected to amputation at the knee or tight level.
Ulcer Healing
Time frame: 7, 30, 60, 90 and 120 days
Defined by total or partial epithelization of the ulcer as measured in total square centimeters.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Derived from this study: PubMed 40202953Oliveira Filho FJ, Rodrigues LDS, Amaral SMBD, Mellucci Filho PL, Medolago NB, de Carvalho Bovolato AL, Alvarado RC, Bertanha M. Study protocol for a randomized clinical trial evaluating the safety and efficacy of autologous adipose-derived stem cell therapy for ulcers in patients with critical limb ischemia. PLoS One. 2025 Apr 9;20(4):e0318922. doi: 10.1371/journal.pone.0318922. eCollection 2025.
- Individual participant dataSharing planned: No
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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.
Lenize S Rodrigues, Ph.D. contact
Francisco J de Oliveira Filho, M.D. principal investigator
São Paulo State University
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CELULAS TRONCO and CONVENTIONAL DRESSING in people with Peripheral Arterial Disease and Leg Ulcer, run by UPECLIN HC FM Botucatu Unesp.
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 9 inclusion and 9 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: opening soon, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matheus Bertanha, Ph.D. (+55(14)3880-1444, matheus.bertanha@unesp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Amputation (time frame: 120 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06326203, which also lists 1 linked publication.
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 6 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.