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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Subcutaneous Injections of ASC to Heal Digital Ulcers in Patients With Scleroderma.

Subcutaneous Injections of Cultured Adipose-derived Stroma/ Stem Cells to Heal Refractory Ischemic Digital Ulcers in Patients With Scleroderma

Subcutaneous Injections of ASC to Heal Digital Ulcers in Patients With Scleroderma. (NCT04356755) is a Phase 2 interventional studying Systemic Sclerosis, sponsored by University Hospital, Toulouse. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

Ischemic digital ulcers (DUs) are a frequent complication in systemic sclerosis with a major impact on hand function and quality of life. Digital injection of cultured adipose-derived stromal cell (AdMSC) constitutes a promising approach to treat scleroderma-induced refractory ischemic DUs where no alternative therapy is validated. The aim of this phase 2 study is to compare efficacy and safety of digital injection of AdMSC versus placebo for healing refractory active ischemic digital ulcers in patients with systemic sclerosis.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Systemic Sclerosis and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 32 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - Male or female patient ≥18 years of age, - Patient with systemic sclerosis according to the 2013 ACR/EULAR classification criteria9, - SSc patient with at least one refractory active ischemic digital ulcer at "inclusion visit" (see below the eligibility conditions of a DU), - Age \> 50 years and not treated with any kind of hormone replacement therapy for at least 2 years prior to screening, with amenorrhea for at least 24 consecutive months prior to screening. An assessment of serum follicle stimulating hormone showing a level of \> 40 TU/L at screening may be used to exclude childbearing potential, based on the discretion of the investigator, - Patient must have provided written willing to sign a consent form prior to enrolment, - Patient must be able to understand their requirements of participating in the protocol, - Patient affiliated to a social security system. - Relative to each DU : The DU at " inclusion visit " must show all the following characteristics: 1. Located beyond the proximal interphalangeal joint, on finger surface (included periungual ulcers), 2. Of ischemic origin according to the physician, 3. Not over subcutaneous calcifications or bone relief, 4. Active DU, 5. Refractory after 10±2 weeks of standard of care according to EULAR recommendations26 (that is either still active (chronic) or new occurrence despite standard of care) Who Should NOT Join This Trial: - Current smoker or tobacco consumption stopped for less than 3 months prior to inclusion, - Patient participating in a clinical trial or having participated in a clinical trial within the previous 3 months, - Patients on statins, who have received treatment for less than 3 months prior to Screening or whose treatment has not been stable during this period, ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Male or female patient ≥18 years of age, * Patient with systemic sclerosis according to the 2013 ACR/EULAR classification criteria9, * SSc patient with at least one refractory active ischemic digital ulcer at "inclusion visit" (see below the eligibility conditions of a DU), * Age \> 50 years and not treated with any kind of hormone replacement therapy for at least 2 years prior to screening, with amenorrhea for at least 24 consecutive months prior to screening. An assessment of serum follicle stimulating hormone showing a level of \> 40 TU/L at screening may be used to exclude childbearing potential, based on the discretion of the investigator, * Patient must have provided written informed consent prior to enrolment, * Patient must be able to understand their requirements of participating in the protocol, * Patient affiliated to a social security system. * Relative to each DU : The DU at " inclusion visit " must show all the following characteristics: 1. Located beyond the proximal interphalangeal joint, on finger surface (included periungual ulcers), 2. Of ischemic origin according to the physician, 3. Not over subcutaneous calcifications or bone relief, 4. Active DU, 5. Refractory after 10±2 weeks of standard of care according to EULAR recommendations26 (that is either still active (chronic) or new occurrence despite standard of care) Exclusion Criteria: * Current smoker or tobacco consumption stopped for less than 3 months prior to inclusion, - Patient participating in a clinical trial or having participated in a clinical trial within the previous 3 months, * Patients on statins, who have received treatment for less than 3 months prior to Screening or whose treatment has not been stable during this period, * Patients on vasodilators, such as endothelin receptor antagonists (ERAs), PDE5 inhibitors (e.g. sildenafil, tadalafil), calcium channel blockers, ACE-inhibitors, nitroglycerin, alpha adrenergic blockers, or angiotensin II receptor antagonists, N-acetylcysteine, antiplatelet aggregation therapy and low molecular weight heparin who have received treatment if present for less than 3 months prior to "inclusion visit" or whose treatment has not been stable for at least 1 month prior to "inclusion visit", * Treatment with disease modifying agents such as methotrexate, mycophenolate mofetil, azathioprine, tacrolimus, Interferons and cyclophosphamide, those drugs should be stop at least 1 month prior study entry. * Treatment with oral corticosteroids (\> 10 mg/day of prednisone or equivalent), * Systemic antibiotics (oral and TV) to treat infected DU(s) within 4 weeks prior to "inclusion visit", * Use of topical growth factors, hyperbaric oxygen, * Local injection of botulinum toxin in an affected finger within 4 weeks prior to "inclusion visit", * Surgical sympathectomy of the upper limbs or surgical wound debridement within 1 month prior to "inclusion visit", * Liposuction technically impossible, * Patient who underwent autologous hematopoietic stem cell transplantation (HSCT) within less than 1 year, * Patients with an indication for intensification by autologous HSCT (according to EBMT guidelines and national RCP MATHEC), * History of cancer in the last five years, except for successfully excised basal cell/squamous cell carcinoma, or successfully excised early melanoma of the skin. Subjects, who had successfully tumor resection or radiation or chemotherapy more than 5 years from inclusion and no recurrence, may be enrolled in the study, - Subjects who have active proliferative retinopathy, * Positive HIV-1 or 2, HTLV-1 or 2, HBV or HCV, * Patients with a history of stroke, myocardial infarction or severe arrhythmia in the last 6 months * Patient who had severe cardiac failure in the last 6 months, * Females who are pregnant or breastfeeding or plan to do so during the course of this study, * Patient under judicial protection, - Refusal of the patient to participate in the study. * Relative to each DU: 1. Digital ulcer due to conditions other than scleroderma, 2. Non ischemic digital ulcer, 3. Ulcers with osteomyelitis, or clinically uncontrolled infection, 4. Infected digital ulcer requiring systemic antibiotherapy, 5. Digital ulcer requiring urgent surgery.

Treatments Being Tested

DRUG

AdMSC

At day 0, patients will have AdMSC injections in their ischemic DU. Patients will be followed-up for 16 weeks

DRUG

Placebo

At day 0, patients will have placebo injections in their ischemic DU. Patients will be followed-up for 16 weeks

Locations (7)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Grenoble Hospital
Grenoble, France
Lille Hopsital
Lille, France
Marseille Hospital
Marseille, France
Montpellier Hospital
Montpellier, France
Nantes Hospital
Nantes, France
Poitiers Hospital
Poitiers, France
CHU de Toulouse - Hôpital PURPAN-TSA
Toulouse, France

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT04356755), the sponsor (University Hospital, Toulouse), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT04356755 clinical trial studying?

Ischemic digital ulcers (DUs) are a frequent complication in systemic sclerosis with a major impact on hand function and quality of life. Digital injection of cultured adipose-derived stromal cell (AdMSC) constitutes a promising approach to treat scleroderma-induced refractory ischemic DUs where no alternative therapy is validated. The aim of this phase 2 study is to compare efficacy and safety of digital injection of AdMSC versus placebo for healing refractory active ischemic digital ulcers in patients with systemic sclerosis. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT04356755?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT04356755?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT04356755. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT04356755. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.