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Stem cell shots aim to heal scleroderma finger sores

NCT ID NCT04356755

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 32 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2020

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    7 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • CHU de Toulouse - Hôpital PURPAN-TSA

    RECRUITING

    Toulouse, 31059, France

  • Grenoble Hospital

    NOT_YET_RECRUITING

    Grenoble, France

  • Lille Hopsital

    NOT_YET_RECRUITING

    Lille, France

  • Marseille Hospital

    NOT_YET_RECRUITING

    Marseille, France

  • Montpellier Hospital

    NOT_YET_RECRUITING

    Montpellier, France

  • Nantes Hospital

    NOT_YET_RECRUITING

    Nantes, France

  • Poitiers Hospital

    NOT_YET_RECRUITING

    Poitiers, France

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