Stem cell shots aim to heal scleroderma finger sores
NCT ID NCT04356755
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether injecting a patient's own cultured fat stem cells into stubborn finger ulcers can help them heal. The study includes 32 adults with scleroderma who have at least one ulcer that hasn't healed with standard care. Half get stem cell injections, half get a placebo, and they are followed for 16 weeks to see if the ulcers shrink or close completely.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- cultured adipose-derived stem cells (AdMSC)
- What this could lead to
- If it works, this could offer a new way to heal painful finger ulcers in scleroderma patients who have no other options.
- What could go wrong
- This is a small, early-phase trial with only 32 people. The treatment may not work better than placebo, and there are risks like infection or worsening ulcers.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 32 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2020
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
7 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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CHU de Toulouse - Hôpital PURPAN-TSA
RECRUITINGToulouse, 31059, France
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Grenoble Hospital
NOT_YET_RECRUITINGGrenoble, France
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Lille Hopsital
NOT_YET_RECRUITINGLille, France
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Marseille Hospital
NOT_YET_RECRUITINGMarseille, France
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Montpellier Hospital
NOT_YET_RECRUITINGMontpellier, France
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Nantes Hospital
NOT_YET_RECRUITINGNantes, France
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Poitiers Hospital
NOT_YET_RECRUITINGPoitiers, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a single drug tame multiple autoimmune diseases?
- Immune clues in the blood may foretell heart trouble
- Blood particles may reveal hidden clues to scleroderma complications
- Could a simple injection dissolve painful calcium lumps in rare diseases?
- Finger injections aim to loosen stiff hands in scleroderma