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

2 1

What is this study about?

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.

1 Initial Infusion

Receive the first intravenous infusion of allogeneic mesenchymal stromal cells derived from adipose tissue. The dosage is 2×10⁶ cells per kilogram of body weight.

This infusion is administered as a suspension for injection.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Rennes	Rennes	France
Awgrmyotwg Pvqbxnnd Hwkbhnji Df Ppkos	Paris	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.10.2024

Trial locations

Investigated drugs:

Allogeneic Adipose-Derived Mesenchymal Stromal Cells, Ex-Vivo Expanded

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.

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 ID:

2023-505977-34-00

Protocol code:

APHP211026

Trial Phase:

Therapeutic exploratory (Phase II)

Other Trials to Consider

#1 Clinical Trials Search in Europe

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?