Study on the Use of Allogenic Adipose-Tissue-Derived Mesenchymal Stem Cells for Healing Chronic Digital Ulcers in Systemic Sclerosis Patients

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What is this study about?

This clinical trial is focused on studying a condition known as systemic sclerosis, which is a disease that affects the skin and internal organs by causing them to harden and tighten. The study aims to explore a new treatment method for healing difficult-to-treat sores on the fingers, known as ischemic digital ulcers, which are common in patients with systemic sclerosis. The treatment being tested is called CellReady, which involves using special cells called allogenic adipose-tissue-derived mesenchymal stem cells. These cells are derived from fat tissue and are believed to help in healing by promoting tissue repair and reducing inflammation.

The purpose of the study is to compare the effectiveness and safety of injecting these stem cells directly into the affected areas of the fingers against a placebo. The trial will last for 16 weeks, during which participants will receive injections and be monitored for improvements in their ulcers. The goal is to see if the ulcers heal completely or partially without coming back and to ensure there are no complications from the treatment.

Participants in the study will receive regular check-ups to monitor their progress and any changes in their condition. The study is designed to provide valuable information on whether this new treatment can offer a better solution for patients suffering from systemic sclerosis with chronic finger ulcers. The findings could potentially lead to improved treatment options for managing this challenging condition.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the presence of systemic sclerosis and at least one active ischemic digital ulcer that meets specific criteria.

The ulcer must be located beyond the proximal interphalangeal joint, on the finger surface, and of ischemic origin. It should not be over subcutaneous calcifications or bone relief and must be refractory after 10±2 weeks of standard care.

2 treatment administration

The treatment involves subcutaneous injections of allogeneic adipose-derived stromal cells (CellReady®).

These injections are administered directly into the digital ulcers. The exact dosage and frequency are determined by the study protocol and are designed to promote healing of the ulcers.

3 monitoring and follow-up

Throughout the 16-week trial period, regular monitoring is conducted to assess the healing progress of the digital ulcers.

The primary goal is to evaluate the proportion of ulcers that heal completely or partially without recurrence and without local or general complications.

4 final evaluation

At the end of the 16-week period, a final evaluation is performed to determine the overall effectiveness and safety of the treatment.

The main evaluation criterion is a composite endpoint combining healing without recurrence and without complications.

Who Can Join the Study?

You must be over 18 years old and have a condition called systemic sclerosis, which is a type of disease that affects the skin and other organs.
You need to have at least one digital ulcer at the start of the study. A digital ulcer is a sore on your finger. It must meet these conditions:
- Located beyond the middle joint of the finger, on the finger surface, including around the nail.
- Caused by poor blood flow, as determined by your doctor.
- Not located over hard lumps under the skin or bone areas.
- Must be an active sore.
- Must not have healed after about 10 to 12 weeks of usual treatment, meaning it is still there or a new one has appeared despite treatment.
You must have given written permission to join the study before starting.
You need to be able to understand what is required to take part in the study.
You must be part of a social security system.

Who Cannot Join the Study?

Patients who do not have systemic sclerosis, a condition that affects the skin and other organs.
Patients who do not have active ischemic digital ulcers, which are painful sores on the fingers or toes that do not heal well due to poor blood flow.
Patients who have not experienced chronic or recurrent ulcers within the last 3 months.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, meaning they may need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Lille	Lille	France
Oncopole Claudius Regaud	Toulouse	France
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Universitaire De Caen Normandie	Caen	France
Cxkflr Hwmogqfkdao Ubrmuyyezxpys Dk Dxpbf	Dijon	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	22.09.2020

Trial locations

CellReady® is a treatment being studied for its ability to heal chronic and recurring digital ulcers in patients with scleroderma. These ulcers are difficult to treat and occur due to poor blood flow. CellReady® consists of stromal cells derived from fat tissue, which are injected into the affected area. The goal is to promote healing by improving blood flow and tissue repair.

Systemic sclerosis – Systemic sclerosis 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 heart, lungs, 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 cause complications in the affected organs, impacting their function. The severity and progression of symptoms can vary widely among individuals.

Trial ID:

2023-508432-53-00

Protocol code:

RC31/17/0447

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Use of Allogenic Adipose-Tissue-Derived Mesenchymal Stem Cells for Healing Chronic Digital Ulcers in Systemic Sclerosis Patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?