Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study on the Safety of Allogeneic Adipose-Derived Mesenchymal Stromal Cells for Patients with Severe Systemic Sclerosis

Verified siteInvestigationalNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a disease called systemic sclerosis, which is a condition that affects the skin and internal organs, causing them to harden and tighten. The treatment being tested involves the use of allogeneic adipose-derived mesenchymal stromal cells, which are special cells taken from fat tissue and grown outside the body. These cells are then given to patients through an intravenous infusion, which means they are delivered directly into the bloodstream. The treatment is sometimes referred to by its code name, MxASC01.

The purpose of this study is to evaluate the safety of this cell therapy in patients with severe systemic sclerosis. Participants in the study will receive the cell treatment once or twice over a period of three months. The study will monitor the participants for any side effects and assess how the treatment affects their condition. The trial will also include a comparison with a placebo to better understand the effects of the cell therapy.

Throughout the study, participants will have regular check-ups to monitor their health and the progression of their disease. The study will last for about a year, with follow-up visits to assess the long-term effects of the treatment. The goal is to determine if this new therapy can be a safe and effective option for people with severe systemic sclerosis.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial Infusion

    Receive the first intravenous infusion of allogeneic mesenchymal stromal cells derived from adipose tissue. The dosage is 2x106 cells per kilogram of body weight.

    This infusion is administered as a suspension for injection.

  2. Step 2

    First Month Monitoring

    One month after the initial infusion, monitoring for any treatment-related severe adverse events is conducted.

    Adverse events are evaluated using a standardized classification system.

  3. Step 3

    Second Infusion

    Three months after the first infusion, a second intravenous infusion of the same dosage is administered.

    This step is similar to the initial infusion, with the same dosage and method of administration.

  4. Step 4

    Fourth Month Monitoring

    One month after the second infusion, monitoring for any treatment-related severe adverse events is conducted again.

    The same standardized classification system is used for evaluation.

  5. Step 5

    Follow-Up Assessments

    Regular follow-up assessments are conducted at months 3, 6, 9, and 12.

    These assessments include evaluations of skin condition, lung function, and overall health-related quality of life.

    Specific tests include the modified Rodnan Skin Score, forced vital capacity, and diffusing capacity of the lung for carbon monoxide.

  6. Step 6

    Final Evaluation

    At the end of the 12-month period, a comprehensive evaluation is conducted to assess the overall effectiveness and safety of the treatment.

    This includes a review of all collected data and any changes in health status.

Who can join the trial?

13 criteria

  • Provide signed and dated informed consent, which means you agree to participate in the study after understanding what it involves.
  • Have health insurance.
  • Be willing to follow all study procedures and be available for the entire duration of the study.
  • Be a male or female aged over 18 years.
  • Have a diagnosis of systemic sclerosis (SSc) according to specific medical guidelines.
  • Have severe disease with specific conditions, such as:
    • Disease duration of 2 years or less with a modified Rodnan skin score (mRSS) of 20 or more, and certain blood test results.
    • mRSS of 15 or more, with at least one major organ involvement due to SSc, such as:
      • Respiratory issues, like reduced lung function or signs of lung disease on imaging tests.
      • Kidney problems related to SSc.
      • Heart issues, such as heart failure or irregular heart rhythms.
      • Have a reason not to undergo a specific treatment called AHSCT, based on patient and doctor judgment.
      • Have a reason not to continue with certain immune system treatments due to side effects or lack of response.
      • Women who can have children must use highly effective birth control methods.
      • Men who can father children must use condoms.

Who cannot join the trial?

10 criteria

  • Patients with other serious health conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients with a history of severe allergic reactions.
  • Patients who are unable to follow the study procedures.
  • Patients with active infections that require treatment.
  • Patients with a history of cancer within the last five years, except for certain skin cancers.
  • Patients with a history of drug or alcohol abuse.
  • Patients who have received certain medications that could affect the study results.
  • Patients with a history of organ transplant.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

MSC-AT: This therapy involves the infusion of mesenchymal stromal cells derived from adipose tissue. These cells are administered intravenously to patients with severe systemic sclerosis. The goal of this treatment is to evaluate its safety and potential benefits in managing the symptoms of this condition. The therapy is given once or twice, with a three-month interval between administrations.

What is already known about the treatment

Allogeneic Adipose Tissue-Derived Mesenchymal Stromal Cells – This medication is administered through an intravenous infusion, typically given once or twice at a three-month interval. It is currently being studied in clinical trials for its safety and effectiveness in treating severe systemic sclerosis. The main therapeutic indication is to manage symptoms and potentially modify the disease course of systemic sclerosis. At the molecular level, these cells are believed to work by modulating the immune system and promoting tissue repair. They are classified under cell-based therapies, specifically as mesenchymal stromal cells derived from adipose tissue.

Investigated diseases

Systemic sclerosis – Systemic sclerosis, also known as scleroderma, is a chronic connective tissue disease characterized by the hardening and tightening of the skin and connective tissues. It primarily affects the skin but can also involve internal organs such as the lungs, heart, and kidneys. The disease progresses with the overproduction of collagen, leading to fibrosis and scarring. Patients may experience symptoms like skin thickening, joint pain, and Raynaud's phenomenon, where fingers and toes turn white or blue in response to cold or stress. As the disease advances, it can lead to complications in organ function due to tissue fibrosis. The severity and progression of symptoms can vary widely among individuals.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-505977-34-00Protocol codeAPHP211026Estimated enrolment18 patientsSponsorAssistance Publique Hopitaux De Paris

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).